Risk stratification with video capsule endoscopy leads to fewer hospital admissions in emergency department patients with low-risk to moderate-risk upper gastrointestinal bleed: A multicenter clinical trial

Objective: In US emergency departments (EDs), the physician has limited ability to evaluate for common and serious conditions of the gastrointestinal (GI) mucosa such as a bleeding peptic ulcer. Although many bleeding lesions are self-limited, the majority of these patients require emergency hospitalization for upper endoscopy (EGD). We conducted a clinical trial to determine if ED risk stratification with video capsule endoscopy (VCE) reduces hospitalization rates for low-risk to moderate-risk patients with suspected upper GI bleeding. Methods: We conducted a randomized controlled trial at 3 urban academic EDs. Inclusion criteria included signs of upper GI bleeding and a Glasgow Blatchford score <6. Patients were randomly assigned to 1 of the following 2 treatment arms: (1) an experimental arm that included VCE risk stratification and brief ED observation versus (2) a standard care arm that included admission for inpatient EGD. The primary outcome was hospital admission. Patients were followed for 7 and 30 days to assess for rebleeding events and revisits to the hospital. Results: The trial was terminated early as a result of low accrual. The trial was also terminated early because of a need to repurpose all staff to respond to the coronavirus disease 2019 pandemic. A total of 24 patients were enrolled in the study. In the experimental group, 2/11 (18.2%) patients were admitted to the hospital, and in the standard of care group, 10/13 (76.9%) patients were admitted to the hospital (P = 0.012). There was no difference in safety on day 7 and day 30 after the index ED visit. Conclusions: VCE is a potential strategy to decrease admissions for upper GI bleeding, though further study with a larger cohort is required before this approach can be recommended.