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

NCT01424254 | Completed Phase 3

• 1 other identifier: REC#03-025
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Bleeding

Keywords

Gastrointestinal Bleeding of Obscure Origin

Outcome Measures

Primary Outcomes (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

  12 months

Secondary Outcomes (6)

• 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

Study Arms (2)

Video-Capsule Endoscopy

EXPERIMENTAL

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

Push Enterosopy

EXPERIMENTAL

Procedure: Push-Enteroscopy

Interventions

Capsule GIVEN IMAGING DEVICE

Injection of Capsule Endoscopy

Video-Capsule Endoscopy

Push-Enteroscopy PROCEDURE

currently recommended standard

Push Enterosopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• Normal gastroscopy, colonoscopy and small bowel follow through in the last 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• American Society for Gastrointestinal Endoscopy: collaborator
• American College of Gastroenterology: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G1A4, Canada

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Double-Balloon Enteroscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Balloon Enteroscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: August 26, 2011
• Study Start: October 1, 2003
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: August 26, 2011

Record last verified: 2011-08

Locations

CA (1)