Using early video capsule endoscopy for suspected upper gastrointestinal bleeding
Official title: A Randomized Controlled Trial Evaluating the Efficacy of Early Videocapsule Endoscopy Following Negative Gastroscopy in Patients Presenting With Suspected Upper Gastrointestinal Bleeding
Run by University of Alberta · NCT05108844 · Data updated 2026-11-12
This study is testing if using a tiny camera to look inside the gut right after a negative gastroscopy can help people with suspected upper gastrointestinal bleeding get better results compared to the usual method of waiting for a colonoscopy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | University of Alberta Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Edmonton, Alberta) |
| Status | Recruiting |
| Started | September 1, 2021 |
| Main results expected | November 30, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | March 16, 2026 |
| Trial ID | NCT05108844 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older experiencing new onset acute gastrointestinal bleeding with a negative gastroscopy.
✕Probably not a fit
Patients who may not benefit include those with prior small bowel surgery, Crohn's disease, strictures, or those unable to provide consent.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of early video capsule endoscopy (VCE) in patients with suspected upper gastrointestinal bleeding (UGIB) who have had a negative gastroscopy. The research compares patient outcomes between those receiving VCE immediately after gastroscopy and those undergoing the standard approach of colonoscopy prior to small bowel investigations. Key metrics such as diagnostic yield, number of procedures, length of hospitalization, mortality rates, and healthcare costs will be analyzed to determine the benefits of this approach.
Why it matters
Potential benefit: If successful, this approach could lead to improved diagnostic accuracy and reduced healthcare costs for patients with upper gastrointestinal bleeding.
How similar studies have gone: While the approach of using early VCE is innovative, similar studies have not been widely conducted, making this a potentially novel investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University of Alberta Hospital
Edmonton, Alberta, Canada Recruiting
Study contacts
- Study coordinator: Sergio Zepeda-Gomez, MD
- Email: zepedago@ualberta.ca
- Phone: 780-248-1578
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.