Neil B Marya1, Salmaan Jawaid2, Anne Foley2, Samuel Han3, Krunal Patel2, Louise Maranda4, Daniel Kaufman2, Kanishka Bhattacharya2, Christopher Marshall2, Joseph Tennyson5, David R Cave2. 1. Vatche and Tamar Manoukian Division of Digestive Diseases, University of California Los Angeles, Los Angeles, California, USA. 2. Department of Medicine, University of Massachusetts, Worcester, Massachusetts, USA. 3. University of Colorado, Aurora, Colorado, USA. 4. Department of Quantitative Health Sciences, University of Massachusetts, Worcester, Massachusetts, USA. 5. Department of Emergency Medicine, University of Massachusetts, Worcester, Massachusetts, USA.
Abstract
BACKGROUND AND AIMS: Patients presenting with nonhematemesis GI bleeding (NHGIB) represent a diagnostic challenge for physicians. We performed a randomized controlled trial to assess the benefits of deployment of a video capsule soon after admission in the management of patients presenting with melena, hematochezia, or severe anemia compared with standard of care management. METHODS:Patients admitted with NHGIB were randomized and placed into 1 of 2 study groups. In the experimental group, patients ingested a video capsule soon after admission to the hospital. These patients had further endoscopic workup based on the findings from the capsule. Patients in the control group underwent endoscopic evaluation (ie, upper endoscopy, capsule endoscopy, and/or colonoscopy) to identify the source of bleeding as directed by the attending gastroenterologist's interpretation of their clinical presentation. The primary endpoint for this study was the rate of localization of bleeding during hospitalization. RESULTS:Eighty-seven patients were included in this study: 45 randomized to the standard of care arm and 42 to the early capsule arm. A bleeding source was localized in 64.3% of the patients in the early capsule arm and in 31.1% of the patients in the standard of care arm (P < .01). The likelihood of endoscopic localization of bleeding over time was greater for patients receiving early capsule endoscopy compared with those in the standard of care arm (adjusted hazard ratio, 2.77; 95% confidence interval, 1.36-5.64). CONCLUSIONS: For patients admitted to the hospital for NHGIB, early capsule endoscopy is a safe and effective alternative for the detection of the source of bleeding. (Clinical trial registration number: NCT02442830.).
RCT Entities:
BACKGROUND AND AIMS: Patients presenting with nonhematemesis GI bleeding (NHGIB) represent a diagnostic challenge for physicians. We performed a randomized controlled trial to assess the benefits of deployment of a video capsule soon after admission in the management of patients presenting with melena, hematochezia, or severe anemia compared with standard of care management. METHODS:Patients admitted with NHGIB were randomized and placed into 1 of 2 study groups. In the experimental group, patients ingested a video capsule soon after admission to the hospital. These patients had further endoscopic workup based on the findings from the capsule. Patients in the control group underwent endoscopic evaluation (ie, upper endoscopy, capsule endoscopy, and/or colonoscopy) to identify the source of bleeding as directed by the attending gastroenterologist's interpretation of their clinical presentation. The primary endpoint for this study was the rate of localization of bleeding during hospitalization. RESULTS: Eighty-seven patients were included in this study: 45 randomized to the standard of care arm and 42 to the early capsule arm. A bleeding source was localized in 64.3% of the patients in the early capsule arm and in 31.1% of the patients in the standard of care arm (P < .01). The likelihood of endoscopic localization of bleeding over time was greater for patients receiving early capsule endoscopy compared with those in the standard of care arm (adjusted hazard ratio, 2.77; 95% confidence interval, 1.36-5.64). CONCLUSIONS: For patients admitted to the hospital for NHGIB, early capsule endoscopy is a safe and effective alternative for the detection of the source of bleeding. (Clinical trial registration number: NCT02442830.).
Authors: Andrew C Meltzer; Alexander T Limkakeng; Nina T Gentile; Jincong Q Freeman; Nicole C Hall; Nataly Montano Vargas; David E Fleischer; Zubair Malik; Samuel J Kallus; Marie L Borum; Yan Ma; Anita B Kumar Journal: J Am Coll Emerg Physicians Open Date: 2021-10-25
Authors: Dennis M Jensen; Alan Barkun; David Cave; Ian M Gralnek; Rome Jutabha; Loren Laine; James Y W Lau; John R Saltzman; Roy Soetikno; Joseph J Y Sung Journal: Aliment Pharmacol Ther Date: 2021-07-20 Impact factor: 9.524