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

Phase 3

Completed

• Conditions: Gastrointestinal Bleeding
• Interventions: Device: Capsule GIVEN IMAGING; Procedure: Push-Enteroscopy

• Registration Number: NCT01424254
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2010-12
• Study Completion: 2011-03
• Status Verified: 2011-08
• Study First Submitted: 2011-08-18
• Study First Submitted QC: 2011-08-25
• Last Update Submitted: 2011-08-25
• Study First Posted: 2011-08-26
• Last Update Posted: 2011-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video-Capsule Endoscopy	Capsule GIVEN IMAGING	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
Push Enterosopy	Push-Enteroscopy	-

Primary Outcome Measures

Name	Time	Method
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	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada