Using early video capsule endoscopy for suspected upper gastrointestinal bleeding
A Randomized Controlled Trial Evaluating the Efficacy of Early Videocapsule Endoscopy Following Negative Gastroscopy in Patients Presenting With Suspected Upper Gastrointestinal Bleeding
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05108844 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older experiencing new onset acute gastrointestinal bleeding with a negative gastroscopy.
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.
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 performed: While the approach of using early VCE is innovative, similar studies have not been widely conducted, making this a potentially novel investigation.
Eligibility criteria
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 this trial is running
Edmonton, Alberta
- University of Alberta Hospital — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Study coordinator: Sergio Zepeda-Gomez, MD
- Email: zepedago@ualberta.ca
- Phone: 780-248-1578
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.