What side effects are associated with this type of intervention?

The most common treatment for small bowel bleeding using non-invasive visualization methods like Video Capsule Endoscopy (VCE) primarily involves the risk of capsule retention, particularly in patients with suspected small bowel obstruction, which may require surgical or endoscopic retrieval. Other minor side effects include discomfort during the procedure and the rare possibility of bowel perforation.

What prior FDA approvals exist?

The FDA has approved Video Capsule Endoscopy (VCE) for the non-invasive visualization of the small bowel to identify sources of bleeding. VCE involves swallowing a capsule equipped with a tiny wireless camera that captures images as it travels through the gastrointestinal tract. This method is particularly useful for diagnosing obscure gastrointestinal bleeding when other diagnostic methods, such as gastroscopy and colonoscopy, are inconclusive. VCE is a significant advancement in the non-invasive diagnosis and management of small bowel bleeding, providing a safer and more comfortable alternative for patients.

What other types of research exist?

Promising alternatives to Early Video Capsule Endoscopy (VCE) for small bowel bleeding include CT enterography, which offers high diagnostic performance, and device-assisted enteroscopy, which allows for deeper visualization of the small bowel. Additionally, repeat upper endoscopy and colonoscopy can be valuable, especially if initial examinations were suboptimal.

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Videocapsule Endoscopy for Gastrointestinal Bleeding

Q: What is the mechanism of action of this treatment?

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.

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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 10Eligibility criteria met

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.