The Effectiveness of Video-capsule Endoscopy in Gastrointestinal Bleeding of Obscure Origin

August 25, 2011 updated by: Alan Barkun, McGill University Health Centre/Research Institute of the McGill University Health Centre
The study objective is to compare the cost-effectiveness of VCE to push enteroscopy in patients with gastrointestinal bleeding of obscure origin with a negative initial work-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: The introduction of the wireless capsule endoscopy (WCE) may dramatically alter the management of patients with small bowel disease such as chronic gastrointestinal bleeding of obscure origin (CGB). Yet, to date, this non invasive technique has undergone widespread diffusion in the absence of properly designed prospective comparative cost-effectiveness evaluations.

Objectives: To examine the clinical impact and cost-effectiveness of a novel approach employing WCE compared to that of push enteroscopy (PE).

Hypothesis: WCE is more cost-effective than PE in patients with CGB. Study design: We propose a randomized clinical trial comparing WCE to PE. Study population: Patients with CGB having undergone initial normal assessment with gastroscopy, colonoscopy and radiological examination of the small bowel.

Outcomes: Primary objective: To compare the detection rates of "clinically significant" small bowel lesions using WCE versus PE in CGB patients randomized to either modality. Secondary objectives: To determine the "cure rate" for each technique after 6 months, the cost-effectiveness of WCE versus PE, the type of small bowel lesions most likely to impact on clinical care, inter-rater variability in reading WCE examinations, the feasibility of WCE interpretation by a dedicated technician, the safety of each imaging modality, and to compare patient satisfaction and quality of life between the two groups.

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G1A4
        • Montreal General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 years old
  • Normal gastroscopy, colonoscopy and small bowel follow through in the last 3 months

Exclusion Criteria:

  • Demonstrable source of blood outside the GI tract
  • Significant cardiopulmonary disease
  • Suspicion of strictures or fistulae of the GI tract
  • Pregnancy
  • Numerous small intestinal diverticula
  • Zenker's diverticulum
  • Extensive Crohn's enteritis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Video-Capsule Endoscopy
VCE will be performed in the early morning following 200 mg of simethicone and 250 - 500 mg of erythromycin (as per physician's prescription), ingestion also in the absence of contra-indications
Device: Capsule GIVEN IMAGING
Injection of Capsule Endoscopy
EXPERIMENTAL: Push Enterosopy
Procedure: Push-Enteroscopy
currently recommended standard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measure is the detection rate of clinically significant lesions thought to be responsible for the patients with gastrointestinal bleeding of obscure origin
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
resolution of the anemia/recurrent bleeding
Time Frame: 12 months
12 months
blood transfusion requirements
Time Frame: 12 months
12 months
Number of required imaging tests (i.e: gastroscopy, colonoscopy, etc)
Time Frame: 12 months
12 months
hospitalization/length of stay
Time Frame: 12 months
12 months
days away from usual activities (protocol unrelated)
Time Frame: 12 months
12 months
patient satisfaction
Time Frame: Following procedure at randomization
Patient satisfaction questionnaire
Following procedure at randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

Canadian Institutes of Health Research (CIHR)
American College of Gastroenterology
American Society for Gastrointestinal Endoscopy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

August 18, 2011

First Submitted That Met QC Criteria

August 25, 2011

First Posted (ESTIMATE)

August 26, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 26, 2011

Last Update Submitted That Met QC Criteria

August 25, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC#03-025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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