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

Study Overview
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Brief Summary
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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
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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
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Gastrointestinal Bleeding

Intervention / Treatment
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* Device: Capsule GIVEN IMAGING
* Procedure: Push-Enteroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video-Capsule Endoscopy<br>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<br>* Injection of Capsule Endoscopy<br>|
| Experimental: Push Enterosopy<br> | Procedure: Push-Enteroscopy<br>* currently recommended standard<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Patient satisfaction questionnaire | Following procedure at randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal Bleeding of Obscure Origin