A randomized controlled trial comparing efficacy of early video capsule endoscopy with standard of care in the approach to nonhematemesis GI bleeding (with videos)

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.).

Copyright © 2019 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1.

Number of patients screened, included, randomized, and analyzed according to intention-to-treat protocol. DNR/DNI, Do not resuscitate/do not intubate.

Figure 2.

Kaplan-Meier analysis of cumulative incidence of localization of bleeding source after presentation to the emergency department (ED) by study cohort.

Figure 3.

Examples of bleeding localized by video capsule endoscopy. A, Active cecal bleeding. Colonoscopy revealed a cecal Dieulafoy lesion. B, Actively bleeding gastric angioectasia. C, Fresh bleeding in the duodenum. Upper endoscopy revealed a duodenal angioectasia. D, Active bleeding identified in the stomach. Upper endoscopy revealed portal hypertensive gastropathy as the source of bleeding.