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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2010

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.

Interventions

  • Device: Capsule GIVEN IMAGING
    • Injection of Capsule Endoscopy
  • Procedure: Push-Enteroscopy
    • currently recommended standard

Arms, Groups and Cohorts

  • 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
  • Experimental: Push Enterosopy

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Collaborator
    • American Society for Gastrointestinal Endoscopy
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alan Barkun, Principal Investigator – McGill University Health Centre/Research Institute of the McGill University Health Centre

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