Braden Kuo, MD, MSc, FACG1, Allen Lee, MD2, Thomas Abell, MD3, Ashok Attaluri, MD4, Michael Cline, DO5, William L. Hasler, MD6, Vincent Ho, MBBS, PhD7, Anthony J. Lembo, MD8, Amir Masoud, MD9, Richard W. McCallum, MD10, Baharak Moshiree, MD11, Eamonn Quigley, MD12, Satish S. C.. Rao, MD, PhD13, Mayra Sanchez, MD14, Irene Sarosiek, MD15, Abigail Stocker, MD3, Brian Surjanhata, MD16, Jerry Zhou, PhD7, William D. Chey, MD, FACG2 1Center for Neurointestinal Health, Massachusetts General Hospital, Boston, MA; 2University of Michigan, Ann Arbor, MI; 3University of Louisville School of Medicine, Louisville, KY; 4Olathe Medical Center, Olathe, KS; 5Cleveland Clinic Foundation, Cleveland, OH; 6Mayo Clinic Arizona, Scottsdale, AZ; 7Western Sydney University, Sydney, New South Wales, Australia; 8Digestive Disease Institute, Cleveland Clinic, Cleveland, OH; 9Hartford Healthcare/Connecticut GI, Madison, CT; 10Texas Tech University Health Sciences Center School of Medicine, El Paso, TX; 11Advocate Health Wake Forest Medical University, Charlotte, NC; 12Houston Methodist Hospital, Houston, TX; 13Medical College of Georgia, Augusta University, Augusta, GA; 14Hartford HealthCare, Hartford, CT; 15Texas Tech University Health Sciences Center El Paso, El Paso, TX; 16Massachusetts General Hospital, Boston, MA
Introduction: Motility disorders, such as gastroparesis and slow transit constipation (STC), are common gastrointestinal (GI) conditions affecting up to 5% of individuals worldwide. The symptoms of motility disorders can be debilitating, affecting quality of life and driving utilization of healthcare systems. Diagnosis relies on evaluation of regional transit times, with delayed gastric and colonic transit indicated for gastroparesis and STC, respectively. A Food and Drug Administration-cleared wireless motility capsule (WMC), has been used in the assessment of gastroparesis and STC since 2008 but has recently been discontinued, leaving a need for a like replacement. This study aimed to assess a novel gas-sensing capsule (GSC) against the WMC for the assessment of regional transit time in these conditions.
Methods: Individuals with upper, lower, or combined GI symptoms were recruited in a prospective multi-centre study. Participants concomitantly ingested the GSC and WMC in a randomized order. Regional transit times including Gastric Emptying Time (GET) and Colonic Transit Time (CTT) were measured and compared between the devices, where paired data were available. GET >5 hours and CTT >59 hours were defined as delayed.
Results: 213 participants were recruited across 12 sites: 177 yielded paired GET results, and 147 for CTT. Pearson correlation coefficients for GET and CTT comparisons between GSC and WMC were 0.86 (0.81-0.89) and 0.74 (0.66 – 0.81) respectively. GET demonstrated a positive predicted value (PPV) of 78.00% (SE: 5.86%), negative predictive value of 85.83% (SE: 3.09%), and overall agreement of 83.62% (SE: 2.78%). For CTT, PPV was 67.35% (SE: 6.70%), negative predictive value was 92.89% (SE: 2.60%), and overall agreement was 84.35% (SE: 3.00%). No serious adverse device effects were reported. 32.2% of the total GET evaluable cohort had delayed GET, 27.2% of the CTT evaluable cohort had delayed CTT. For the cohort that had measurement for all transit regions, 20% had delayed CTT only, 11% had delayed GET only and 18% had a delay in multiple GI regions as measured by GSC.
Discussion: The GSC exhibited substantial agreement with WMC in measuring both GET and CTT, highlighting its utility as a potential replacement for the discontinued WMC for assessment of motility disorders. Observations of multi-regional dysmotility further highlight the value of measuring multiple regional of the GI tract with a single test.
Figure: Part A: Correlation of WMC GET measure to GSC GET measure, Pearson R = 0.86. Part B: Correlation of WMC CTT measure to GSC CTT measure, Pearson R = 0.74. Part C: Venn diagram showing regional transit delay as measured by the GSC.
Braden Kuo, MD, MSc, FACG1, Allen Lee, MD2, Thomas Abell, MD3, Ashok Attaluri, MD4, Michael Cline, DO5, William L. Hasler, MD6, Vincent Ho, MBBS, PhD7, Anthony J. Lembo, MD8, Amir Masoud, MD9, Richard W. McCallum, MD10, Baharak Moshiree, MD11, Eamonn Quigley, MD12, Satish S. C.. Rao, MD, PhD13, Mayra Sanchez, MD14, Irene Sarosiek, MD15, Abigail Stocker, MD3, Brian Surjanhata, MD16, Jerry Zhou, PhD7, William D. Chey, MD, FACG2, 21, Comparative Evaluation of Gas-Sensing Capsule and Wireless Motility Capsule for Transit Time Assessment in Motility Disorders, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.
