Recruiting

Videocapsule Endoscopy

Sponsor:

University of Alberta

Code:

NCT05108844

Conditions

Small Bowel Bleeding

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Videocapsule endoscopy

Study Details

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

Study ID

NCT05108844

Start date

Sep 1, 2021

Status verified date

Mar, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 18 years
  • New onset of acute gastrointestinal bleeding defined as:

1. The presence of melena/maroon stool on physical exam OR history of melena/maroon stool within 48 hours of emergency room presentation PLUS
2. 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Early small bowel investigation

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

active comparator: Colonoscopy

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

Interventions

Videocapsule endoscopy

Endoscopic drop of videocapsule in duodenum after initial negative gastroscopy

Primary outcome measure

  • Diagnostic yield [ Time Frame: 30 days ]
  • Diagnostic yield of colonoscopy after initial negative gastroscopy [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Sergio Zepeda-Gomez, MD

780-248-1578zepedago@ualberta.ca

David Yang, MD

647-502-7658dyyang@ualberta.ca

Locations

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada

Contacts

Sergio Zepeda-Gomez

7802481578zepedago@ualberta.ca

David Yang

6475027658dyyang@ualberta.ca

More Information

Sponsor

University of Alberta

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-03-16.