NCT01424254

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Capsule GIVEN IMAGING	Injection of Capsule Endoscopy
PROCEDURE	Push-Enteroscopy	currently recommended standard

Timeline

• Start date: 2003-10-01
• Primary completion: 2010-12-01
• Completion: 2011-03-01
• First posted: 2011-08-26
• Last updated: 2011-08-26

Locations

1 site across 1 country: Canada