Early Videocapsule Endoscopy for Upper Gastrointestinal Bleeding

NCT05108844 | Recruiting DMC

• 1 other identifier: Pro00111216
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine whether early video capsule endoscopy (VCE) immediately after a negative gastroscopy in the setting of suspected upper gastrointestinal bleeding (UGIB) improves patient outcomes as compared to the standard approach which typically involves performing colonoscopy prior to small bowel investigations. We aim to examine the differences in diagnostic yield, total number of procedures, length of hospitalization, mortality rates, and healthcare cost between the two groups.

Conditions

Small Bowel Bleeding

Outcome Measures

Primary Outcomes (2)

• Diagnostic yield

  Diagnostic yield of videocapsule endoscopy after initial negative gastroscopy

  30 days

• Diagnostic yield of colonoscopy after initial negative gastroscopy

  30 days

Secondary Outcomes (4)

• Time from presentation to localization of bleeding source

  30 days

• Recurrence of bleeding

  30 days

• Length of stay in hospital

  30 days

• Adverse events in both groups

  30 days

Study Arms (2)

Early small bowel investigation

EXPERIMENTAL

Patients in the early small bowel investigation group will undergo VCE immediately after their initial negative gastroscopy

Procedure: Videocapsule endoscopy

Colonoscopy

ACTIVE COMPARATOR

Participants with negative gastroscopy will undergo bowel preparation and colonoscopy the next day

Procedure: Videocapsule endoscopy

Interventions

Videocapsule endoscopy PROCEDURE

Endoscopic drop of videocapsule in duodenum after initial negative gastroscopy

Colonoscopy; Early small bowel investigation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• New onset of acute gastrointestinal bleeding defined as:
• The presence of melena/maroon stool on physical exam OR history of melena/maroon stool within 48 hours of emergency room presentation PLUS
• Hemoglobin drop of ≥ 20 g/L from patient's baseline
• Have capacity to consent
• Hemodynamically stable (i.e. blood pressure \>100/60 or pulse \<110 at the time of consent)
• Initial gastroscopy negative for active bleeding or potential bleeding source

You may not qualify if:

• Inability to provide consent due to lack of capacity, language barrier or other reasons
• Pregnant women
• Prior history of small bowel surgery
• Prior history of Crohn's disease
• Prior history of small bowel or colonic strictures
• Prior history of abdominal radiation

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, Canada

RECRUITING

Central Study Contacts

Sergio Zepeda-Gomez, MD

CONTACT

780-248-1578; zepedago@ualberta.ca

David Yang, MD

CONTACT

647-502-7658; dyyang@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 5, 2021
• Study Start: September 1, 2021
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)