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

Gastrointestinal Bleeding Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01424254
• Other study ID #: REC#03-025
• Status: Completed
• Phase: Phase 3
• First received: August 18, 2011
• Last updated: August 25, 2011
• Start date: October 2003
• Est. completion date: March 2011

Study information

• Verified date: August 2011
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardCanada: Therapeutic Products Programme (TPP)Canada: MUHC Research Ethics Boards
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastrointestinal Bleeding
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Device:
• Capsule GIVEN IMAGING
Injection of Capsule Endoscopy

Procedure:
• Push-Enteroscopy
currently recommended standard

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
McGill University Health Center	American College of Gastroenterology, American Society for Gastrointestinal Endoscopy, Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	resolution of the anemia/recurrent bleeding		12 months	No
Secondary	blood transfusion requirements		12 months	No
Secondary	Number of required imaging tests (i.e: gastroscopy, colonoscopy, etc)		12 months	No
Secondary	hospitalization/length of stay		12 months	No
Secondary	days away from usual activities (protocol unrelated)		12 months	No
Secondary	patient satisfaction	Patient satisfaction questionnaire	Following procedure at randomization	No