NCT03458000

Capsule Endoscopy for HEmorrhage in the ER

Capsule Endoscopy for Hemorrhage in the ER

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: George Washington University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a multi-center randomized controlled trial examining the use of Video Capsule Endoscopy (VCE) to discharge low-moderate risk patients with suspected upper gastrointestinal bleeds (UGIB) from the Emergency Department (ED.) The investigators will enroll 100 subjects at 4 sites who present with signs of hemodynamically stable UGIBs and compare VCE risk assessment to an Active Control (AC) group who receive inpatient upper endoscopy (EGD).

Detailed description

Video capsule endoscopy (VCE) was initially approved in 2001 by the Food and Drug Administration. VCE offers potential advantages over traditional EGD including the ability to be performed 24 hours a day without sedation and interpreted at the bedside by emergency physicians. In addition, VCE is much less invasive, is painless, and enables the patient to pursue normal daily activities after the procedure. Our primary goal is to test whether ED Video Capsule Endoscopy (VCE) is able to safely discharge low risk patients for outpatient evaluation and management. Our secondary objective is to estimate the sensitivity and specificity of VCE compared to subsequent EGD in the detection of serious bleeding lesions in the upper gastrointestinal (GI) tract. Research Coordinator will screen potential patients with signs of upper GI bleeding. Patients who screen as eligible will be approached about potential interest, to review of inclusion and exclusion criteria, and obtain informed consent. Research Coordinator will calculate traditional risk stratification scores and once enrolled, all subjects will be randomized to either Active Control (AC) \[admission plus EGD within hospital stay\] or experimental Capsule Endoscopy Risk Assessment (CERA) in ED. Only patients randomized to the experimental arm will receive video capsule endoscopy in the emergency department.Within 2 hours of presenting to the ED, patient will ingest video capsule-- RC will monitor progress on real-time viewer for passage through pylorus. Upon passing the pylorus, we will record 5 more minutes of video or until battery runs out - whichever occurs first. Patient data will be completed using a standardized data collection tool including the following elements: chief complaint of patient, history of present illness, past medical history, pertinent lab findings, current medications, vital signs, focused physical exam findings and all relevant treatments administered during the ED and hospital stay. For Active Control (AC) group each patient will be admitted. During hospital admission, EGD will be performed on all subjects and hemostasis therapy applied as necessary. The study team decided against mandating that EGD be performed within 24 hours of hospital admission.

Conditions

• Upper Gastrointestinal Bleeding

Interventions

Type	Name	Description
DEVICE	PillCam UGI	An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract.
OTHER	Standard of Care	Patient was admitted to hospital for care and received in-patient EGD.

Timeline

• Start date: 2018-04-17
• Primary completion: 2020-03-15
• Completion: 2020-09-07
• First posted: 2018-03-08
• Last updated: 2023-06-01
• Results posted: 2023-06-01

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study