The Effectiveness of Video-capsule Endoscopy in Gastrointestinal Bleeding of Obscure Origin
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 79
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Time Frame: 12 months
Secondary Outcomes
- 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)
Investigators
Alan Barkun
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre