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Videocapsule Endoscopy for Gastrointestinal Bleeding

N/A
Recruiting
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Hemodynamically stable (i.e. blood pressure >100/60 or pulse <110 at the time of consent)
Must not have
Prior history of abdominal radiation
Prior history of small bowel or colonic strictures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

Summary

This trial tests if using a small camera pill when an initial test fails to find bleeding in patients can improve outcomes. It aims to help doctors find hidden bleeding sources more quickly and comfortably, potentially reducing hospital stays and costs.

Who is the study for?
This trial is for adults over 18 who are stable after a new episode of upper gastrointestinal bleeding, evidenced by dark stools or a significant drop in hemoglobin. They must have had an initial negative gastroscopy and be able to consent. It's not for those with prior abdominal radiation, Crohn's disease, small bowel surgery or strictures, language barriers affecting consent, or pregnant women.
What is being tested?
The study tests if doing an early videocapsule endoscopy right after a negative gastroscopy can improve outcomes for patients with suspected upper GI bleeding compared to the standard method which usually involves a colonoscopy first. Outcomes include diagnostic accuracy, number of procedures needed, hospital stay length, mortality rates and costs.
What are the potential side effects?
Videocapsule endoscopy is generally safe but potential side effects may include discomfort during swallowing the capsule, risk of capsule retention especially in people with narrowing in their bowels (not eligible for this trial), and minor risks associated with sedation if used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My blood pressure is stable and within normal ranges.
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I am able to understand and agree to the study's procedures and risks.
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My first stomach exam showed no signs of bleeding.
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I recently started bleeding from my gut and my blood levels have dropped significantly.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had radiation therapy to my abdomen before.
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I have had narrowings in my small intestine or colon before.
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I have a history of Crohn's disease.
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I have had surgery on my small intestine before.
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I am unable to give consent for the trial due to language barriers or other reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Diagnostic yield

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Early small bowel investigationExperimental Treatment1 Intervention
Patients in the early small bowel investigation group will undergo VCE immediately after their initial negative gastroscopy
Group II: ColonoscopyActive Control1 Intervention
Participants with negative gastroscopy will undergo bowel preparation and colonoscopy the next day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Videocapsule endoscopy
2009
N/A
~70

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for small bowel bleeding often start with non-invasive visualization techniques such as Video Capsule Endoscopy (VCE). VCE involves swallowing a small capsule equipped with a camera that captures images of the small bowel, helping to identify bleeding sources. This method is crucial as it allows for the detection of lesions, tumors, or other abnormalities without the need for invasive procedures. If VCE identifies a bleeding source, further treatments may include endoscopic interventions, angiography, or surgery to manage the bleeding. These approaches are vital for small bowel bleeding patients as they enable precise localization and treatment of the bleeding, thereby reducing the risk of complications and improving patient outcomes.

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
913 Previous Clinical Trials
390,363 Total Patients Enrolled

Media Library

Videocapsule Endoscopy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05108844 — N/A
~0 spots leftby Sep 2024
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