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

NCT ID: NCT01424254

Last Updated: 2011-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2011-03-31

Brief Summary

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.

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.

Conditions

Gastrointestinal Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Capsule GIVEN IMAGING

Intervention Type: DEVICE

Injection of Capsule Endoscopy

Push Enterosopy

Group Type: EXPERIMENTAL

Push-Enteroscopy

Intervention Type: PROCEDURE

currently recommended standard

Interventions

Capsule GIVEN IMAGING

Injection of Capsule Endoscopy

Intervention Type: DEVICE

Push-Enteroscopy

currently recommended standard

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Society for Gastrointestinal Endoscopy

OTHER

Sponsor Role: collaborator

American College of Gastroenterology

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Alan Barkun

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Montreal General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

REC#03-025

Identifier Type: -

Identifier Source: org_study_id