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

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ClinicalTrials.gov Identifier: NCT01424254
Recruitment Status : Completed
First Posted : August 26, 2011
Last Update Posted : August 26, 2011
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

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Bleeding Device: Capsule GIVEN IMAGING Procedure: Push-Enteroscopy Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Study Start Date : October 2003
Actual Primary Completion Date : December 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. resolution of the anemia/recurrent bleeding [ Time Frame: 12 months ]
  2. blood transfusion requirements [ Time Frame: 12 months ]
  3. Number of required imaging tests (i.e: gastroscopy, colonoscopy, etc) [ Time Frame: 12 months ]
  4. hospitalization/length of stay [ Time Frame: 12 months ]
  5. days away from usual activities (protocol unrelated) [ Time Frame: 12 months ]
  6. patient satisfaction [ Time Frame: Following procedure at randomization ]
    Patient satisfaction questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)

Responsible Party: Alan Barkun, Principal Investigator, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01424254     History of Changes
Other Study ID Numbers: REC#03-025
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: August 26, 2011
Last Verified: August 2011

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

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