Medical Policies - Medicine


Gastrointestinal (GI) Motility Measurement

Number:MED201.017

Effective Date:10-01-2018

Coverage:

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Measurement of gastrointestinal transit times, including gastric emptying and colonic transit times, using an ingestible pH and pressure capsule or cutaneous electrogastrography (EGG) are considered experimental, investigational and/or unproven including, but not limited to, for evaluation of suspected gastroparesis, constipation, or other gastrointestinal motility disorders.

Colon motility (manometric) testing is considered experimental, investigational and/or unproven for all indications.

Description:

Electrogastrography (EGG)

Cutaneous EGG is a noninvasive test that detects gastric motility by recording the frequency and regularity of gastric myoelectrical activity. The test is purported to investigate the mechanisms of gastric motility by means of surface electrodes. The cutaneous signals are low in amplitude and heavily contaminated by noise, and visual analysis is inadequate. EGG cannot determine the etiology of detected abnormalities due a lack of specificity and predictive value of the tests.

Ingestible pH and Pressure Capsule

Gastroparesis is a chronic disorder characterized by delayed gastric emptying in the absence of mechanical obstruction. Symptoms of gastroparesis are often nonspecific and may mimic other gastrointestinal tract disorders. It can be caused by many conditions; most commonly it is idiopathic, diabetic, or postsurgical.

Gastric emptying scintigraphy is considered the reference standard for diagnosing gastroparesis. The patient ingests a radionuclide-labeled standard meal and subsequent imaging is performed at 0, 1, 2, and 4 hours postprandially, to measure how much of the meal has passed beyond the stomach. A typical threshold to indicate abnormal gastric emptying is more than 10% of the meal remaining at 4 hours after ingestion.

Constipation is a chronic disorder involving infrequent bowel movements, a sensation of obstruction, and incomplete evacuation. Many medical conditions can cause constipation, such as mechanical obstruction, metabolic conditions, myopathies, and neuropathies. Diagnostic testing for constipation can aid in distinguishing between 2 categories of disorders, slow-transit constipation and pelvic floor dysfunction.

Standard tests used in the evaluation of constipation include ingestion of radiopaque markers and colonic transit scintigraphy. In the radiopaque markers test, small markers are ingested over 1 or several days, and abdominal radiographs are performed at 4 and/or 7 days. The number of remaining markers correlates with the colonic transit time. In colonic transit scintigraphy, a radio-labeled meal is ingested, followed by scintigraphic imaging at several time intervals. The location of the scintigraphic signals correlates with colonic transit times.

Colon Motility (Manometric) Testing

Colon motility testing or colonic manometry is the recording of intraluminal pressures from within the large bowel by means of a manometric catheter, which is positioned endoscopically and clipped to the colonic mucosa. Pressure activity is continuously recorded for a minimum of six hours. This test has been proposed to evaluate motility abnormalities and defecation disorders such as constipation.

Regulatory Status

In 2006, an ingestible capsule (SmartPill® GI Monitoring System; Given Imaging) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process, for evaluation of delayed gastric emptying. Gastric emptying is signaled when the pH monitor in the capsule indicates a change in pH from the acidic environment of the stomach to the alkaline environment of the small intestine. While SmartPill does not measure 50% emptying time, it can be correlated with scintigraphically measured 50% emptying time. The capsule also measures pressure and temperature during its transit through the entire gastrointestinal tract, allowing calculations of total gastrointestinal tract transit time. In 2009, the FDA expanded the use of the SmartPill to determine colonic transit time for the evaluation of chronic constipation and to differentiate between slow-versus normal-transit constipation. When colonic transit time cannot be determined, small and large bowel transit times combined can be used instead. The SmartPill is not for use in pediatric patients.

Rationale:

This medical policy was developed in 1993 and has been updated regularly with searches of Medline database. The most recent literature update was performed through March 2018.

Assessment of a diagnostic technology typically focuses on 3 categories of evidence: 1) technical reliability (test-retest reliability or interrater reliability); 2) clinical validity (sensitivity, specificity, positive and negative predictive values) in relevant populations of patients; and 3) clinical utility (i.e., demonstration that the diagnostic information can be used to improve patient outcomes). Additionally, when considering invasive monitoring, any improvements in patient outcomes must be outweighed by device-related risks associated with testing.

Electrogastrography (EGG)

Technical Reliability

EGG recording faces several technical challenges, many of them related to measuring cutaneous signals, rather than directly measuring electrical activity along the stomach mucosa or serosa. One of the parameters of the EGG analyzed is the power of the signal, commonly thought to increase after the digestion of a meal. However, the power of the signal can also be influenced by the proximity of the electrode to the stomach wall, which can change as the stomach distends after a meal (1, 2) Changes in frequency, such as tachyarrhythmias and bradyarrhythmias, are commonly reported. However, EGG artifacts, such as movement artifacts and signal drift, may limit interpretation. Simultaneous recordings of cutaneous and internal EGGs suggest that cutaneous EGG records more episodes of tachyarrhythmias, probably due to the accumulation of artifacts. The use of computer-assisted analysis, which may not be able to identify and eliminate movement artifacts, must be interpreted very cautiously. Day to day variability of the EGG is another important issue, as measured by repeated EGG in the same patient over a short period of time.

Calder et al. (2016) reported that the routine screening and accurate diagnosis of chronic gastrointestinal (GI) motility disorders represent a significant problem in current clinical practice. (3) EGG provides a non-invasive option for assessing gastric slow waves, as a means of diagnosing gastric dysrhythmias, but its uptake in motility practice has been limited partly due to an incomplete sensitivity and specificity. The reviewers presented the development of a human whole-organ gastric model to enable virtual (in silico) testing of gastric electrophysiological dispersion to improve the diagnostic accuracy of EGG. The model was developed to simulate normal gastric slow wave conduction and 3 types of dysrhythmias identified in recent high resolution gastric mapping studies: 1) conduction block, 2) re-entry, and 3) ectopic pace-making.

The stomach simulations were applied in a torso model to identify predicted EGG signatures of normal and dysrhythmic slow wave profiles. The resulting EGG data were compared using percentage differences and correlation coefficients. Virtual EGG channels that demonstrated a percentage difference over 100% and a correlation coefficient less than 0.2 (threshold relaxed to 0.5 for the ectopic pace-maker case) were further investigated for their specific distinguishing features. In particular, anatomical locations from the epigastric region and specific channel configurations were identified that could be used to clinically diagnose the 3 classes of human gastric dysrhythmia. The authors concluded that these locations and channels predicted by simulations present a promising methodology for improving the clinical reliability and applications of EGG.

Clinical Validity

Several studies have compared EGG with gastric emptying tests and have reported a poor correlation between the two. (4-8) Two of the larger studies are reviewed here. Chen and colleagues performed both EGG and scintigraphic gastric emptying in 97 patients with symptoms suggestive of gastroparesis. (7) Considering gastric emptying tests as the gold standard, the authors concluded that patients with delayed gastric emptying had either a lower percentage of normal slow waves or a higher prevalence of gastric dysrhythmias, or both. However, the sensitivities of these 3 parameters were 24%, 42%, or 14%, respectively, while the corresponding specificities were 92%, 87%, and 100%. The authors concluded that an abnormal EGG may predict delayed gastric emptying, although a normal EGG will not rule out delayed gastric emptying. One hypothesis is that normal gastric myoelectrical activity is one of many prerequisites for normal gastric emptying.

Parkman et al. correlated abnormalities in EGG with gastric emptying and symptom severity in 72 patients with functional dyspepsia (FD). (8) Patients were recruited from those who were referred for a gastric emptying scintigraphy. A total of 22 patients (31%) had an abnormal EGG, and 22 (31%) had an abnormal gastric emptying test. The EGG was abnormal in 11 of the 22 patients (50%) with an abnormal gastric emptying test. If the gastric emptying scintigraphy is considered the gold standard, the EGG had a sensitivity of 50% and a specificity of 78%. While these data suggest that EGG cannot be substituted for gastric emptying scintigraphy, it must be noted that the 2 tests are measuring different aspects of gastric activity. Therefore, another question is the clinical significance of those with abnormal EGGs but negative emptying tests and whether the 2 tests are complementary. Patients with abnormalities in both tests tended to report increased symptom severity, but the authors did not comment on the diagnostic significance of this observation.

One study did focus on how EGG could be used as an adjunct to gastric emptying studies, by focusing on the subset of patients with known delayed gastric emptying and no dysrhythmias observed on the EGG. (9) The authors concluded that while the patients with idiopathic gastroparesis were likely to have gastric dysrhythmias, patients with mechanical obstruction were more likely to have persistent and prominent 3 cycles per minute EGG patterns, which are seen in normal EGGs. This observation suggests that patients with known gastroparesis based on gastric emptying studies may be further evaluated with an EGG. If no dysrhythmias are found, the patients may be referred for further tests to identify subtle mechanical obstructions. If EGG dysrhythmias are found, the patients might benefit from a trial of a prokinetic agent. However, this study was retrospective in nature, and the results must be confirmed in larger prospective studies.

Other studies have focused on the use of EGG in diabetic patients as a research tool to study the pathogenesis of diabetic gastroparesis. Kawagishi et al., studied the relationship between glucose control, autonomic neuropathy, and EGG findings. They concluded that improved glycemic control and improved autonomic nerve function were associated with normalization of gastric myoelectrical activity. (10) Mantides et al., reported that abnormalities in the EGG are frequently detected in diabetes even without symptoms of gastroparesis. (11)

Kayar et al. (2017) utilized transcutaneous EGG to compare patients with FD (n=30) to control subjects (n=30) in terms of motility abnormalities according to the EGG results. (12) The authors concluded that a high incidence of gastric motility and myoelectrical activity abnormalities was observed in patients with FD. Although it is considered an experimental method, EGG is an effective, reliable, and non-invasive method in differentiating the subgroups and may be an essential and irreplaceable test to diagnose and follow-up patients with FD with motor dysfunction.

Clinical Utility

No study focused on the final patient outcomes in patients undergoing EGGs. Outcomes of interest could include the avoidance of unnecessary tests or unnecessary treatment, or the institution of potentially more effective treatment. Based on the studies reviewed here, due to the low sensitivity of EGG for diagnosis of gastric motility disorders compared to scintigraphic gastric-emptying studies, it is unlikely that EGG can supplant tests of gastric emptying. As an adjunct to gastric-emptying tests, 1 study suggested that EGG could be used to distinguish patients with mechanical obstruction from idiopathic gastroparesis. (9) However, this study did not include patient outcomes.

The published literature suggests that EGG is primarily used as a research tool in patients with a variety of disorders. (13-16) Other studies continue to focus on the technical performance of the test (17, 18), including the use of multichannel recording compared to single channel recording. (19) No study was identified that elucidated the diagnostic performance of EGG in different populations of patients or how this information could be used to benefit patient management.

Section Summary: Electrogastrography

While EGG may be an interesting research tool to study the correlation between gastric electrical activity and disease, data are inadequate to determine how the results of this test may be used to benefit patient management.

Wireless pH and Pressure Capsules

Technical Reliability

We did not identify any literature assessing the technical reliability of wireless pH pressure capsules.

Clinical Validity

Gastric Emptying

Although scintigraphy is considered the reference standard for evaluating gastric emptying, several issues complicate its use as a reference test. Until recently, there has been a lack of test standardization. (23) Significant day-to-day variability in the rate of gastric emptying has also been noted. (24)

Due to a lack of standardization and small sample sizes referenced in published studies, the capability of the gastric emptying test to discriminate between healthy individuals and those with known gastroparesis is uncertain. In a 2000 study by Tougas et al., 123 healthy subjects were assessed to determine the normal period required for nearly complete evacuation of a standardized meal from the stomach. (25) The authors suggested that the threshold of normality for gastric retention at 4 hours is 10% meal retention. The cutoff point was set to include 95% of normal persons. However, it appears to be unknown if this same threshold adequately identifies persons who would otherwise be classified as having gastroparesis and who are candidates or responders to treatment.

A few published studies have evaluated the ingestible capsule in relation to another diagnostic measure of gastric emptying. A 2013 systematic review of 12 studies on the ingestible capsule was published by the Agency for Healthcare Research and Quality (AHRQ). (26) Studies that included only healthy participants were excluded from the review; instead, AHRQ looked for studies with comparison groups consisting of healthy, asymptomatic (i.e., without symptoms of gastroparesis or constipation) participants as controls, thus limiting interpretation of the comparisons. Among these studies, the overall strength of evidence favoring the ingestible capsule was low. Diagnostic accuracy with the ingestible capsule was considered comparable to gastric scintigraphy in 7 studies, with diagnostic agreement ranging from 58% to 86% for test agreement when test results were positive and 64% to 81% when results were negative. There was a moderate correlation between the ingestible capsule and gastric emptying scintigraphy on transit data and device agreement in 5 studies. Three studies that evaluated transit time reported similar sensitivity and specificity rates for the ingestible capsule and scintigraphy.

In 2008, Cassilly et al. evaluated the SmartPill and simultaneous gastric emptying scintigraphy in 15 healthy subjects. (27) The capsule was ingested immediately following the radiolabeled test meal. In this study, the mean time for 50% gastric emptying by scintigraphy was 95 minutes, 90% gastric emptying by scintigraphy was 194 minutes, and gastric residence time by SmartPill was 261 minutes. The correlation coefficient (r) between SmartPill and 50% gastric emptying time was 0.606, and between SmartPill and 90% gastric emptying time it was 0.565. The average amount of meal remaining in the stomach at the time the SmartPill exited the stomach was 5.4%. This study showed only modest correlation of the SmartPill and gastric emptying scintigraphy and was too small to establish reference values for the SmartPill.

In a 2008 study by Kuo et al., 87 healthy subjects and 61 subjects with symptoms and prior positive test results for gastroparesis were evaluated with both the SmartPill and gastric emptying scintigraphy. (28) In this study, subjects ingested the capsule just before consuming the standard meal. This led to the premature passage of the SmartPill in 5 subjects (<30 minutes), whose tests were subsequently considered invalid. Sixteen other subjects had equipment malfunctions, and 2 others dropped out.

Among the remaining 125 subjects, the correlation coefficient (r) between SmartPill gastric emptying time and scintigraphy at 2 hours was 0.63, and between SmartPill gastric emptying time and scintigraphy at 4 hours was 0.73. Regarding the capability to discriminate between gastroparetic patients and healthy subjects, the area under the curve was 0.83 for SmartPill, 0.82 for scintigraphy at 4 hours, and 0.79 for scintigraphy at 2 hours (all p>0.05), indicating similar capability of each for discriminating between the 2 patient groups. At a cutoff point of 300 minutes for the SmartPill, which was established by calculating the ideal cutoff point from the data, sensitivity was 65% and specificity was 87%. The sensitivity and specificity for scintigraphy using an established cutoff point from the literature of 10% at 4 hours was 44% and 93%, respectively.

Regarding adverse events reported in the study by Kuo et al., 5 (7%) of 67 subjects who did not retrieve the capsule required a second additional plain radiograph (x-ray) beyond 5 days to demonstrate that the capsule had been passed. (28) Another patient ingested a laxative that caused the capsule to be entrapped in a viscous mass. An unsuccessful endoscopy ensued, followed by treatment with intravenous erythromycin to pass the capsule from the stomach.

A 2009 study by Maqbool et al. assessed SmartPill and gastric emptying scintigraphy in 10 healthy asymptomatic subjects. (29) Emptying time assessed by SmartPill correlated with the percent meal retained at 2 and 4 hours. The correlation coefficient (r) between SmartPill and 2-hour scintigraphy was 0.95. The correlation between SmartPill and 4-hour scintigraphy was 0.73.

A 2013 study by Green et al. assessed SmartPill and gastric emptying scintigraphy in 22 pediatric patients with severe upper gastrointestinal symptoms. (30) Of 20 evaluable patients who had both tests, 9 patients had delayed gastric emptying identified by scintigraphy. SmartPill was 100% sensitive and 50% specific for delayed gastric emptying. Patients also underwent antroduodenal manometry to detect motor abnormalities. SmartPill identified motor abnormalities in 17 patients, compared with 10 detected by antroduodenal manometry. However, there does not appear to be a reference standard for motor abnormalities. Thus, it cannot be determined whether SmartPill is more sensitive or whether it has a higher false-positive rate for detection of motor abnormalities.

Section Summary: Clinical Validity Gastric Emptying

The data present several shortcomings on the use of the SmartPill in diagnosing gastroparesis; as a result, the diagnostic accuracy is not well defined. The current reference test (gastric emptying scintigraphy) is an imperfect criterion standard, and this creates difficulties in defining the sensitivity and specificity of SmartPill. All studies cited here included healthy asymptomatic subjects either entirely or as part of a control group. Healthy subjects are not a fair representation of the clinically relevant group under consideration for a diagnosis of delayed gastric emptying. Ideally, the relevant population of subjects should be symptomatic or under evaluation for a diagnosis of gastroparesis. Although there was a moderate correlation between SmartPill gastric emptying time and scintigraphy, scintigraphy itself has limited reliability. Although the areas under the curve between SmartPill and scintigraphy are similar, the modest correlation between the 2 tests indicates that there are often discordant results.

Colonic Transit Time

Few studies have evaluated the use of SmartPill for assessing colonic transit times. In the 2013 systematic review by AHRQ, the strength of evidence in available studies on the ingestible capsule was found to be low overall. (26) Accuracy of the ingestible capsule in diagnosing slow-transit constipation was similar to tests using radiopaque markers and scintigraphy. The moderate correlation between colonic transit times with the ingestible capsule and tests with radiopaque markers was shown in 5 studies (r range, 0.69-0.71).

In the 2009 study by Maqbool et al. (discussed earlier), healthy asymptomatic subjects underwent simultaneous whole gut scintigraphy and SmartPill assessment of whole-gut transit times. (29) The 2 techniques correlated with each other reasonably well. In a 2009 study by Rao et al., healthy subjects and subjects with constipation had whole-gut transit times assessed with radiopaque markers and the SmartPill. (31) Diagnostic accuracy of the 2 techniques in differentiating the 2 groups of patients was similar. Camilleri et al. (2010) compared the wireless motility capsule with radiopaque markers in 158 patients with chronic functional constipation. (32) In this multicenter validation study, the authors reported that positive percent agreement between the wireless motility capsule and radiopaque markers was approximately 80% for colonic transit time (95% confidence interval [CI], 0.67 to 0.98). No serious adverse events were reported.

The U.S. Food and Drug Administration has received 1 adverse event report (according to their MAUDE [Manufacturer and User Facility Device Experience] database), in which the capsule was trapped in the stomach of a patient and required endoscopic removal.

Section Summary: Clinical Validity Colonic Transit Time

Although the studies cited here show moderate correlations between SmartPill and other methods for assessing colonic transit times, they should be interpreted cautiously. Two studies included healthy subjects, who are not the appropriate comparator sample needed to evaluate a diagnostic test. These studies also did not identify a population with known slow-transit constipation, which is the clinically relevant subset of patients with constipation that the test seeks to identify. Thus, the diagnostic capability of SmartPill for detecting slow-transit constipation is unknown.

Clinical Utility

Gastric Emptying and Colonic Transit Times

The clinical utility of the test depends on the frequency, duration, and interpretation of imaging and is affected by factors including the use of different test meals and patient positioning. Demonstration of clinical utility further requires that the technology is associated with change(s) in management that lead to improved health outcomes.

The 2013 AHRQ review found that there was a lack of evidence on the clinical utility of testing with the ingestible capsule. (26) Therefore, the evidence was insufficient to conclude the impact of testing results of the ingestible capsule on treatment and management decisions.

In a 2011 retrospective study by Kuo et al. 83 patients were evaluated for gastroparesis, small intestinal dysmotility, and slow-transit constipation; the authors found that wireless motility capsule testing resulted in a new diagnosis in 44 (53%) patients. (33) Changes to clinical management were recommended for 65 patients and included adjustments in medication regimens in 39 (60%) patients and in nutrition programs in 9 (14%) patients. Four (6%) patients were referred to surgery for colectomy. Abnormal gastric emptying or small intestinal transit times did not influence patient management at all (p=NS). Abnormal colonic transit times did not influence nutritional program changes (p=0.72) but did influence medication changes (p=0.02) and resulted in a trend toward increased surgical referrals (p=0.12). The authors suggested that wireless motility capsule testing eliminated the need for nuclear gastric emptying testing in 9 (17%) of 52 patients, barium radiography testing in 7 (54%) of 13 patients, and radiopaque marker testing in 41 (68%) of 60 patients. They also noted a need for prospective studies to further understand wireless motility capsule testing and its role in patient management.

In a 2011 retrospective study of 86 patients with persistent symptoms of gastrointestinal dysmotility despite normal endoscopic and radiologic test results, Rao et al. found that evaluations using wireless motility capsule testing resulted in new diagnostic information in 26 (53%) of 50 patients with lower gastrointestinal symptoms and 17 (47%) of 36 patients with upper gastrointestinal symptoms. (34) Clinical management was influenced by wireless motility capsule testing in 30% of patients with lower gastrointestinal symptoms and in 50% of patients with upper gastrointestinal symptoms. The retrospective nature of this study limits interpretation of results.

In a 2015 retrospective review of patients who underwent evaluation with SmartPill for suspected multiregional gastrointestinal dysmotility, Arora et al. reported abnormal test results in 109 (67.7%) of 161 subjects. (35) Of these patients, multiregional dysmotility was diagnosed in 54 (49.5%). Although this study demonstrated a high diagnostic yield among patients with a particular suspected condition, it did not demonstrate improved patient outcomes compared with standard tests.

Section Summary: Clinical Utility

Evidence on the clinical utility of a wireless pressure capsule is very limited, consisting of 3 retrospective analyses describing outcomes of patients undergoing testing with SmartPill. These studies lacked control subjects diagnosed without the test or with alternative tests. This evidence is insufficient to determine the clinical utility of SmartPill for either indication; higher quality studies are still needed to measure the impact of SmartPill on patient management and improved health outcomes.

Ongoing and Unpublished Clinical Trials

Some currently unpublished trials that might influence this review are listed in Table 1.

Table 1. Summary of Key Trials

NCT No.

Trial Name

Planned Enrollment

Completion Date

Unpublished

NCT02022826a

Clinical Management With SmartPill Motility Monitoring System and Validation of the SmartPill Five Hour Cutoff in Patients With Symptoms of Gastroparesis

167

Dec 2016 (terminated)

NCT: national clinical trial.

a Denotes industry-sponsored or cosponsored trial.

Colonic Motility Testing or Colonic Manometry

Technical Reliability

In 2018, Sanghavi et al. published a retrospective chart review of 36 patients that underwent placement of the colonic manometry catheter (ages ranging from 3 to 16 years, weights 12 to 95?kg) using the single balloon technique. (40) All patients had prior preparation with nasogastric Golytely. Catheter placement was successful in all cases with procedure times of 20 to 105 minutes. No major complications were noted. The authors stated that this is the first reported series of using single balloon-assisted colonoscopy to perform difficult colonoscopy in children and place colonic manometry catheters. It may have other therapeutic implications in children such as removal of polyps or placement of similar catheters.

Colonic manometry is used often in children with constipation that is long standing and difficult to manage to aid in management decisions. Accurate analysis requires placement of the colonic manometry catheter in the colon without looping. This is technically difficult due to the long-standing nature of the constipation in most patients leading to sigmoid and other colonic redundancy. The authors reported the first series of single balloon-assisted colonoscopy for performing difficult colonoscopy in children and placing colonic manometry catheters.

Wiklendt et al. (2013) conducted a manual analysis of data obtained from manometric studies. (41) It evaluated an automated analysis technique of colonic manometry data that was developed to differentiate the motor patterns of 17 patients with slow transit constipation (STC) from those recorded in 14 healthy controls. According to the authors, manual analysis of data is laborious, subject to laboratory bias and not specific enough to differentiate all patients from control subjects. The authors found that automated analysis of colonic manometry data using cross-correlation separated all patients from controls. This study is limited by a small sample size (n=17).

Clinical Validity

Giorgio et al. (2013) sought to correlate neuromuscular histological phenotypes in pediatric STC with colonic manometric phenotypes using high-resolution manometry (HRM). (42) They tested the hypothesis that failure of motor quiescence (FQ) between bisacodyl-induced high amplitude propagating sequences (HAPSs) might predict neuromuscular pathology. Eighteen children (10 males, median age: 7.5 years) with refractory STC underwent stationary colonic HRM before segmental colonic resection. Six age-matched constipated children with normal colonic transit were the controls. Conventional manometric parameters and area under the curve (AUC) during a 1-minute period following bisacodyl-induced HAPSs [PBAUC(1)], as measure of FQ, were calculated. In segments with HAPS, PBAUC(1) was predictive of colonic neuropathy using a cutoff of 205 mmHg.s (-1) (Sensitivity 100%, specificity 86%, PPV 92%, NPV 100%). The authors concluded that PBAUC(1) is increased in multiple colonic segments in neuropathic pediatric STC and constitutes a sensitive and specific biomarker of neuropathy. The small study population limits the validity of the conclusion of this study.

Clinical Utility

Singh et al. (2013) investigated whether colonic manometric evaluation is useful for characterizing colonic sensorimotor dysfunction and for guiding therapy in STC. (43) A 24-hour ambulatory colonic manometry was performed in 80 patients with STC by placing a six-sensor solid-state probe, along with assessment of colonic sensation with barostat. Anorectal manometry was also performed. Manometrically, patients were categorized as having colonic neuropathy or myopathy based on gastrocolonic response, waking response and high amplitude propagated contractions (HAPC); and based on colonic sensation, as colonic hyposensitivity or hypersensitivity. Clinical response to pharmacological, biofeedback, and surgical treatment was assessed at 1 year and correlated with manometric findings. Forty-seven (59%) patients who had abnormal colonic manometry, with features suggestive of neuropathy (26%), and myopathy (33%); 41% had normal colonic manometry. Seventy-four percent of the patients had abnormal colonic sensation and 61% had overlapping dyssynergic defecation. Patients with neuropathy were more likely to have colonic hyposensitivity. Sixty-four percent of patients with colonic myopathy or normal manometry improved with medical/biofeedback therapy when compared to 15% with colonic neuropathy. Selected patients with colonic neuropathy had excellent response to surgery, but many developed bacterial overgrowth. The authors concluded that colonic manometry demonstrates significant colonic sensorimotor dysfunction in STC patients and reveals considerable pathophysiological heterogeneity. They reported that colonic manometry can be useful for characterizing the underlying pathophysiology and for guiding clinical management in STC, especially surgery. The study was limited, as it lacked a controlled comparator group.

Pensabene et al. (2003) conducted a retrospective review of medical records for 145 children to evaluate the impact of colonic manometry in clarifying pathophysiology of childhood defecatory disorders and evaluated its impact on management. (44) Treatment changes were recommended in 93% of patients after colonic manometry. Changes in medical treatment were suggested for 121 patients (81%). Surgical treatment (cecostomy, subtotal or total colectomy, myectomy) was suggested for 102 (68%), mostly in addition to the changes in medical treatment or recommended in case the medical treatment had failed. Surgery was the only recommendation for 18 children. Follow up was done in 65% of the families. When recommendations were followed (96% of the contacted patients), the symptoms improved in 78%, were unchanged in 18%, and were worse in 4% of patients. Among the parents, 88% believed that the suggestions given after colonic manometry had been helpful in improving their children's health. According to the authors, the study limitations include the shortcomings of a retrospective study. In addition, the duration of follow-up was variable, there was no control group, and only two thirds of the families were contacted for follow up.

Section Summary: Colonic Motility Testing or Colonic Manometry

There is currently insufficient evidence regarding the effectiveness of colon manometry or colonic motility testing. Patient selection criteria and the role of colonic manometry in the management of motility abnormalities must be better defined in well-designed studies.

Practice Guidelines and Position Statements

Electrogastrography

American Gastroenterological Association

In 2001, the American Gastroenterological Association published a medical position statement on nausea and vomiting (20), which offered the following conclusion:

“Although well-documented disorders of enteric nerve and muscle such as the pseudo-obstruction syndrome may result in nausea and vomiting, the role of gastrointestinal dysmotility and gastroparesis, in particular, in the patient with isolated chronic nausea and vomiting remains unclear. Although gastroparesis is common among patients in this category, its primacy remains in dispute, and the interrelationships between such entities as functional and psychogenic vomiting, idiopathic gastroparesis, and functional dyspepsia remain unclear. For these same reasons, the place of such tests of motor function as gastric emptying studies, electrogastrography, and manometry have not been defined, and the yield of such diagnostic studies has not been adequately compared with a therapeutic trial of an antiemetic and/or prokinetic agents.”

In 2004, a position statement on the diagnosis and treatment of gastroparesis from the American Gastroenterological Association reported that the guideline developers discussed, but did not recommend, the use of EGG to test for gastric myoelectrical activity. (21) Overall, the literature indicates that the use of EGG is investigational; therefore, the coverage statement is unchanged.

Ingestible pH and Pressure Capsule

American Neurogastroenterology and Motility Society

The American Neurogastroenterology and Motility Society issued a consensus statement on intraluminal measurement of gastrointestinal and colonic motility in clinical practice in 2008. (36) In this consensus statement, formal recommendations on any type of test were not issued. It was noted that SmartPill could be used to identify delayed gastric emptying, but that the impact of the technology on patient management has not been studied. Use of SmartPill to assess colonic motility was noted, but no mention was made of its use to measure colonic transit time.

American and European Neurogastroenterology and Motility Societies

The American and European Neurogastroenterology and Motility Societies issued a position paper on the evaluation gastrointestinal transit in 2011. (37) In it, the wireless motility capsule was recommended by consensus for assessing gastric emptying and small bowel, colonic, and whole-gut transit times in patients with suspected gastroparesis or gastrointestinal dysmotility in multiple regions. However, the position paper noted that the clinical utility of identifying delays in small bowel transit times is unknown.

American Gastroenterological Association

The American Gastroenterological Association’s 2013 guidelines on gastroparesis diagnosis and treatment indicate wireless motility capsule testing requires validation before it can be considered as an alternative to scintigraphy for diagnosing gastroparesis. (38) Gastric emptying scintigraphy is considered the best accepted method to test for delays in gastric emptying.

Colonic Motility Testing or Colonic Manometry

American Gastroenterological Association

An American Gastroenterological Association 2013 medical position statement includes a guideline on constipation that states colonic intraluminal testing (manometry, barostat) should be considered to document colonic motor dysfunction before colectomy (weak recommendation, moderate-quality evidence). (45) A weak recommendation implies that benefits, risks, and the burden of intervention are more closely balanced, or appreciable uncertainty exists in regard to patient’s values and preferences.

A 2013 AGA’s technical review on constipation states that colonic manometry or barostat-manometric testing should be considered in patients with medically refractory slow transit constipation (STC). (46) However, these tests are only available in highly specialized centers with a research interest and their role in management is not well established. Colonic manometry may identify a subset of patients with STC colonic motor dysfunctions that may be explained by a marked reduction in colonic intrinsic nerves and interstitial cells of Cajal. This should prompt consideration of colonic resection in medically refractory patients who do not have pelvic floor dysfunction.

Summary of Evidence

For individuals who have suspected gastroparesis and other gastric or intestinal disorders, some published literature suggests that EGG is primarily used as a research tool and other studies continue to focus on the technical performance of the test. There are inadequate data to determine how the results of this test may be used to benefit patient management. The evidence is insufficient to determine the effects of electrogastrography on patient health outcomes.

For individuals who have suspected disorders of gastric emptying or suspected slow-transit constipation who receive diagnostic testing with an ingestible pH and pressure capsule, the evidence includes studies of test characteristics and case series of patients who have undergone the test. Relevant outcomes are test accuracy and validity, other performance measures, symptoms, functional outcomes, and health status measures. The available studies provide some comparative date on the SmartPill ingestible pH plus pressure-sensing capsule and other techniques for measuring gastric emptying and colonic transit times. The evidence primarily consists of assessments of concordance with available tests. Because the available tests (e.g., gastric emptying scintigraphy) are imperfect criterion standards, it is not possible to determine the true sensitivity and specificity of SmartPill. The results of the concordance studies have revealed a moderate correlation with alternative tests, but have provided only limited additional data on the true accuracy of the test in clinical care. Evaluation of cases with discordant results would be of particular value, and ideally, these studies should be linked to therapeutic decisions and to meaningful clinical outcomes. The evidence to date on clinical utility of testing is lacking, consisting of a small number of retrospective studies. It is not possible to determine whether there is net improvement in health outcomes using SmartPill versus standard diagnostic tests. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals with motility abnormalities, the available studies for the use of colonic motility testing or colonic manometry includes small sample size studies, studies that lack controlled comparator group, and the need for a better-defined patient selection criterion. The evidence is insufficient to determine the effects of the technology on health outcomes.

Contract:

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions. Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply. If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Coding:

CODING:

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps.

CPT/HCPCS/ICD-9/ICD-10 Codes

The following codes may be applicable to this Medical policy and may not be all inclusive.

CPT Codes

91112, 91117, 91132, 91133, 91299

HCPCS Codes

None

ICD-9 Diagnosis Codes

Refer to the ICD-9-CM manual

ICD-9 Procedure Codes

Refer to the ICD-9-CM manual

ICD-10 Diagnosis Codes

Refer to the ICD-10-CM manual

ICD-10 Procedure Codes

Refer to the ICD-10-CM manual


Medicare Coverage:

The information contained in this section is for informational purposes only. HCSC makes no representation as to the accuracy of this information. It is not to be used for claims adjudication for HCSC Plans.

The Centers for Medicare and Medicaid Services (CMS) does not have a national Medicare coverage position. Coverage may be subject to local carrier discretion.

A national coverage position for Medicare may have been developed since this medical policy document was written. See Medicare's National Coverage at <http://www.cms.hhs.gov>.

References:

Cutaneous Electrogastrograph (EGG)

1. Verhagen MA, Van Schelven LJ, Samsom M, et al. Pitfalls in the analysis of electrogastrographic recordings. Gastroenterology. Aug 1999; 117(2):453-60. PMID 10419928

2. Bortolotti M. Electrogastrography: a seductive promise, only partially kept. Am J Gastroenterol. Oct 1998; 93(10):1791-4. PMID 9772032

3. Calder S, O’Grady G, Cheng LK, et al. A Theoretical Analysis of Electrogastrography (EGG) Signatures Associated With Gastric Dysrhythmias. IEEE Trans Biomed Eng. Jul 2017; 64(7): 1592-1601. PMID 28113227

4. Koch KL, Medina M, Bingaman S, et al. Gastric dysrhythmia and visceral sensations in patients with functional dyspepsia. Gastroenterology. 1992; 102:A469.

5. Koch KL, Stern RM, Stewart WR, et al. Gastric emptying and gastric myoelectrical activity in patients with diabetic gastroparesis: effect of long-term domperidone treatment. Am J Gastroenterol. Sep 1989; 84(9):1069-75. PMID 2773901

6. Smout AJ, Jebbink HJ, Akkermans LM, et al. Role of electrogastrography and gastric impedance measurements in evaluation of gastric emptying and motility. Dig Dis Sci. Dec 1994; 39(12 suppl):110S-113S. PMID 7995202

7. Chen JD, Lin Z, Pan J, et al. Abnormal gastric myoelectrical activity and delayed gastric emptying in patients with symptoms suggestive of gastroparesis. Dig Dis Sci. Aug 1996; 41(8):1538-45. PMID 8769276

8. Parkman HP, Miller MA, Trate D, et al. Electrogastrography and gastric emptying scintigraphy are complementary for assessment of dyspepsia. J Clin Gastroenterol. Jun 1997; 24(4):214-9. PMID 9252843

9. Brzana RJ, Koch KL, Bingaman S. Gastric myoelectrical activity in patients with gastric outlet obstruction and idiopathic gastroparesis. Am J Gastroenterol. Oct 1998; 93(10):1803-9. PMID 9772035

10. Kawagishi T, Nishizawa Y, Emoto M, et al. Gastric myoelectrical activity in patients with diabetes: Role of glucose control and autonomic nerve function. Diabetes Care. May 1997; 20(5):848-53. PMID 9135954

11. Mantides A, Stefanides G, Kioulanis J, et al. Cutaneous electrogastrography for the assessment of gastric myoelectrical activity in type I diabetes mellitus. Am J Gastroenterol. Jul 1997; 92(7):1190-3. PMID 9219797

12. Kayar Y, Danalioglu A, Kafee AA, et al. Gastric myoelectrical activity abnormalities of electrogastrography in patients with functional dyspepsia. Turk J Gastroenetol. Sep 2016; 27(5):415-420. PMID 27782888

13. Aktay AN, Splaingard ML, Miller T, et al. Electrogastrography in children with cystic fibrosis. Dig Dis Sci. Apr 2002; 47(4):699-703. PMID 11991595

14. Levy J, Harris J, Chen J, et al. Electrogastrographic norms in children: toward the development of standard methods, reproducible results, and reliable normative data. J Pediatr Gastoenterol Nutr. Oct 2001; 33(4):455-61. PMID 11698763

15. Koch KL. Electrogastrography: physiological basis and clinical application in diabetic gastropathy. Diabetes Technol Ther. Spring 2001; 3(1):51-62. PMID 11469708

16. Mathur R, Pimentel M, Sam CL, et al. Postprandial improvement of gastric dysrhythmias in patients with type II diabetes: identification of responders and nonresponders. Dig Dis Sci. Apr 2001: 46(4):705-12. PMID 11330402

17. Koch KL, Hong SP, Xu L. Reproducibility of gastric myoelectrical activity and the water load test in patients with dysmotility-like dyspepsia symptoms and in control subjects. J Clin Gastroenterol. Sep 2000; 31(2):125-9. PMID 10993427

18. Lin Z, Eaker EY, Sarosiek I, et al. Gastric myoelectrical activity and gastric emptying in patients with functional dyspepsia. Am J Gastroenterol. Sep 1999; 94(9):2384-9. PMID 10483996

19. Simonian HP, Panganamamula K, Chen JZ, et al. Multichannel electrogastrography (EGG) in symptomatic patients: a single center study. Am J Gastroenterol. Mar 2004; 99(3):478-85. PMID 15056089

20. American Gastroenterological Association. American Gastroenterological Association medical position statement: nausea and vomiting. Gastroenterology. Jan 2001; 120(1):261-3. PMID 11208735

21. American Gastroenterological Association, Parkman HP, Hasler WL, et al. American Gastroenterological Association medical position statement: diagnosis and treatment of gastroparesis. Gastroenterology. Nov 2004; 127(5):1589-91. PMID 15521025

22. Cutaneous Electrogastrography (EGG) (Archived). Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2009 December) Medicine 2.01.34.

Ingestible pH and Pressure Capsule

23. Abell TL, Camilleri M, Donohoe K, et al. Consensus recommendations for gastric emptying scintigraphy: a joint report of the American Neurogastroenterology and Motility Society and the Society of Nuclear Medicine. J Nucl Med Technol. Mar 2008; 36(1):44-54. PMID 18287197

24. American Gastroenterological Association, Parkman HP, Hasler WL, et al. American Gastroenterological Association technical review on the diagnosis and treatment of gastroparesis. Gastroenterology. Nov 2004; 127(5):1592-1622. PMID 15521026

25. Tougas G, Eaker EY, Abell TL, et al. Assessment of gastric emptying using a low fat meal: establishment of international control values. Am J Gastroenterol. Jun 2000; 95(6):1456-1462. PMID 10894578

26. Stein E, Berger Z, Hutfless S, et al. Wireless Motility Capsule Versus Other Diagnostic Technologies for Evaluating Gastroparesis and Constipation: A Comparative Effectiveness Review. Rockville (MD): Agency for Healthcare Research and Quality; 2013.

27. Cassilly D, Kantor S, Knight LC, et al. Gastric emptying of a non-digestible solid: assessment with simultaneous SmartPill pH and pressure capsule, antroduodenal manometry, gastric emptying scintigraphy. Neurogastroenterol Motil. Apr 2008; 20(4):311-319. PMID 18194154

28. Kuo B, McCallum RW, Koch KL, et al. Comparison of gastric emptying of a nondigestible capsule to a radio- labelled meal in healthy and gastroparetic subjects. Aliment Pharmacol Ther. Jan 15 2008; 27(2):186-196. PMID 17973643

29. Maqbool S, Parkman HP, Friedenberg FK. Wireless capsule motility: comparison of the SmartPill GI monitoring system with scintigraphy for measuring whole gut transit. Dig Dis Sci. Oct 2009; 54(10):2167-2174. PMID 19655250

30. Green AD, Belkind-Gerson J, Surjanhata BC, et al. Wireless motility capsule test in children with upper gastrointestinal symptoms. J Pediatr. Jun 2013; 162(6):1181-1187. PMID 23290514

31. Rao SS, Kuo B, McCallum RW, et al. Investigation of colonic and whole-gut transit with wireless motility capsule and radiopaque markers in constipation. Clin Gastroenterol Hepatol. May 2009; 7(5):537-544. PMID 19418602

32. Camilleri M, Thorne NK, Ringel Y, et al. Wireless pH-motility capsule for colonic transit: prospective comparison with radiopaque markers in chronic constipation. Neurogastroenterol Motil. Aug 2010; 22(8):874-882, e233. PMID 20465593

33. Kuo B, Maneerattanaporn M, Lee AA, et al. Generalized transit delay on wireless motility capsule testing in patients with clinical suspicion of gastroparesis, small intestinal dysmotility, or slow transit constipation. Dig Dis Sci. Oct 2011; 56(10):2928-2938. PMID 21625964

34. Rao SS, Mysore K, Attaluri A, et al. Diagnostic utility of wireless motility capsule in gastrointestinal dysmotility. J Clin Gastroenterol. Sep 2011; 45(8):684-690. PMID 21135705

35. Arora Z, Parungao JM, Lopez R, et al. Clinical utility of wireless motility capsule in patients with suspected multiregional gastrointestinal dysmotility. Dig Dis Sci. May 2015; 60(5):1350-1357. PMID 25399332

36. Camilleri M, Bharucha AE, di Lorenzo C, et al. American Neurogastroenterology and Motility Society consensus statement on intraluminal measurement of gastrointestinal and colonic motility in clinical practice. Neurogastroenterol Motil. Dec 2008; 20(12):1269-1282. PMID 19019032

37. Rao SS, Camilleri M, Hasler WL, et al. Evaluation of gastrointestinal transit in clinical practice: position paper of the American and European Neurogastroenterology and Motility Societies. Neurogastroenterol Motil. Jan 2011; 23(1):8-23. PMID 21138500

38. Camilleri M, Parkman HP, Shafi MA, et al. Clinical guideline: management of gastroparesis. Am J Gastroenterol. Jan 2013; 108(1):18-37; quiz 38. PMID 23147521

39. Ingestible pH and Pressure Capsule. Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual (2017 November) Medicine 2.01.81.

Colonic Motility Testing or Colonic Manometry

40. Sanghavi RM, Medina-Centeno R, Barth B. Single-Balloon-assisted Colonoscopy for Placement of Colonic Manometry Catheters: Initial Experience in Children. J Pediatr Gastroenterol Nutr. Mar 22 2018. PMID 29570555

41. Wiklendt L, Mohammed SD, Scott SM, et al. Classification of normal and abnormal colonic motility based on cross-correlations of pancolonic manometry data. Neurogastroenterol Motil. Mar 2013; 25(3):e215-23. PMID 23360122

42. Giorgio V, Borrelli O, Smith VV, et al. High-resolution colonic manometry accurately predicts colonic neuromuscular pathological phenotype in pediatric slow transit constipation. Neurogastroenterol Motil. Jan 2013; 25(1):70-8.e8-9. PMID 23030503

43. Singh S, Heady S, Coss-Adame E, et al. Clinical utility of colonic manometry in slow transit constipation. Neurogastroenterol Motil. Jun 2013; 25(6):487495. PMID 23384415

44. Pensabene L, Youssef NN, Griffiths JM, et al. Colonic manometry in children with defecatory disorders. role in diagnosis and management. Am J Gastroenterol. May 2003; 98(5):1052-7. PMID 12809827

45. American Gastroenterological Association, Bharucha AE, Dorn SD, et al. American Gastroenterological Association medical position statement on constipation. Gastroenterology. Jan 2013; 144(1):211-7. PMID 23261064

46. Bharucha AE, Pemberton JH, Locke GR 3rd. American Gastroenterological Association technical review on constipation. Gastroenterology. Jan 2013; 144(1):218-38. PMID 23261065

Policy History:

Date Reason
10/1/2018 Document updated with literature review. The following statement was added to Coverage: Colon motility (manometric) testing is considered experimental, investigational and/or unproven for all indications. References 3,12, and 40-46 were added.
4/15/2017 Reviewed. No changes.
4/15/2016 Document updated with literature review. Coverage unchanged.
7/1/2015 Reviewed. No changes.
7/1/2014 Document updated with literature review. Coverage unchanged.
9/15/2012 Document updated with literature review. Title changed from “Gastrointestinal (GI) Motility using the Smart Pill GI Monitoring System” to “Gastrointestinal (GI) Motility Measurement.” The following changes were made: coverage was clarified, duodenal-jejunal manometry (DJM) was removed from coverage statement. The following statement was removed “This policy is no longer scheduled for routine literature review and update.” CPT/HCPCS code(s) updated. Rationale revised.
12/15/2010 CPT codes updated.
12/1/2008 Revised/updated entire document
6/1/2008 Policy reviewed without literature review; new review date only. This policy is no longer scheduled for routine literature review and update.
10/1/2006 Revised/updated entire document
1/1/2006 CPT/HCPCS code(s) updated
7/1/2004 Revised/updated entire document
4/1/1993 New medical document

Archived Document(s):

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