Clinical trial NCT01424254: The Effectiveness of Video-capsule Endoscopy in Gastrointestinal Bleeding of Obscure Origin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastrointestinal Bleeding
Keywords: Gastrointestinal Bleeding of Obscure Origin
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: American Society for Gastrointestinal Endoscopy
name: American College of Gastroenterology
name: Canadian Institutes of Health Research (CIHR)
First posted: 2011-08-26
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: resolution of the anemia/recurrent bleeding
timeFrame: 12 months
measure: blood transfusion requirements
timeFrame: 12 months
measure: Number of required imaging tests (i.e: gastroscopy, colonoscopy, etc)
timeFrame: 12 months
measure: hospitalization/length of stay
timeFrame: 12 months
measure: days away from usual activities (protocol unrelated)
timeFrame: 12 months
measure: patient satisfaction
timeFrame: Following procedure at randomization
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
References: