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

Condition(s) targeted: Gastrointestinal Bleeding

Intervention: Capsule GIVEN IMAGING (Device); Push-Enteroscopy (Procedure)

Phase: Phase 3

Status: Completed

Sponsored by: McGill University Health Center

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Primary outcome: 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

Secondary outcome:

resolution of the anemia/recurrent bleeding

blood transfusion requirements

Number of required imaging tests (i.e: gastroscopy, colonoscopy, etc)

hospitalization/length of stay

days away from usual activities (protocol unrelated)

patient satisfaction

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Montreal General Hospital, Montreal, Quebec H3G1A4, Canada

Starting date: October 2003
Last updated: August 25, 2011