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

McGill University

Status and phase: Completed; Phase 3

Conditions: Gastrointestinal Bleeding

Treatments: Device: Capsule GIVEN IMAGING; Procedure: Push-Enteroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01424254

REC#03-025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

79 participants in 2 patient groups

Video-Capsule Endoscopy

Experimental group

Description:

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

Treatment:

Device: Capsule GIVEN IMAGING

Push Enterosopy

Experimental group

Treatment:

Procedure: Push-Enteroscopy