The Effectiveness of Video-capsule Endoscopy in Gastrointestinal Bleeding of Obscure Origin
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.
Device: Capsule GIVEN IMAGING
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
- 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 ] [ Designated as safety issue: No ]
- resolution of the anemia/recurrent bleeding [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- blood transfusion requirements [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Number of required imaging tests (i.e: gastroscopy, colonoscopy, etc) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- hospitalization/length of stay [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- days away from usual activities (protocol unrelated) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- patient satisfaction [ Time Frame: Following procedure at randomization ] [ Designated as safety issue: No ]Patient satisfaction questionnaire
|Study Start Date:||October 2003|
|Study Completion Date:||March 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Experimental: Video-Capsule Endoscopy
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
Device: Capsule GIVEN IMAGING
Injection of Capsule Endoscopy
|Experimental: Push Enterosopy||
currently recommended standard
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424254
|Montreal General Hospital|
|Montreal, Quebec, Canada, H3G1A4|