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

This study has been completed.
Sponsor:
Collaborators:
American Society for Gastrointestinal Endoscopy
American College of Gastroenterology
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Alan Barkun, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01424254
First received: August 18, 2011
Last updated: August 25, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastrointestinal Bleeding
 Device: Capsule GIVEN IMAGING
Procedure: Push-Enteroscopy
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 79
Study Start Date: October 2003
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Procedure: Push-Enteroscopy
currently recommended standard

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424254

Locations
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G1A4
Sponsors and Collaborators
McGill University Health Center
American Society for Gastrointestinal Endoscopy
American College of Gastroenterology
Canadian Institutes of Health Research (CIHR)
  More Information

No publications provided

Responsible Party: Alan Barkun, Principal Investigator, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01424254     History of Changes
Other Study ID Numbers: REC#03-025
Study First Received: August 18, 2011
Last Updated: August 25, 2011
Health Authority: United States: Institutional Review Board
Canada: Therapeutic Products Programme (TPP)
Canada: MUHC Research Ethics Boards

Keywords provided by McGill University Health Center:
Gastrointestinal Bleeding of Obscure Origin

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013