Capsule Endoscopy or Mesenteric Angiogram in Patients With Overt Gastrointestinal Bleeding (GIB) of Obscure Origin

May 9, 2008 updated by: Chinese University of Hong Kong

Capsule Endoscopy or Mesenteric Angiogram in Patients With Overt Gastrointestinal Bleeding of Obscure Origin: A Randomized Study

To compare the diagnostic yield of mesenteric angiogram with CE in patients with active obscure GIB.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gastrointestinal bleeding (GIB) of obscure origin is a common conditions resulting in recurrent hospitalization and extensive investigations. Mesenteric angiogram is one of the standard radiological investigations for GIB of obscure origin, and its diagnostic yield ranged from 40-80%. Capsule endoscopy (CE) is a newly available investigation for small bowel examination, especially in bleeding of obscure origin. The diagnostic yield is particularly high in patients with ongoing bleeding. This is a prospective randomized study to compare the diagnostic yield of mesenteric angiogram with CE in patients with overt GIB of obscure origin. The results will help to define the optimal management strategy for this group of patients.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong(SAR), China
        • Endoscopy Center, Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients admitted to PWH medical or surgical wards with melena or hematochezia in whom OGD and colonoscopy fail to identify site of bleeding.
  • Normal or non-diagnostic OGD and colonoscopy
  • Informed consent
  • Patients presented with shock will be resuscitated for urgent endoscopy

Exclusion Criteria:

  • Patients remained in shock despite resuscitation.
  • Moribund patients
  • Terminal malignancy
  • Presence of pacemaker or ICD
  • Suspected or confirmed intestinal obstruction
  • Swallowing difficulties
  • Renal failure that preclude angiographic examination
  • Pregnancy
  • Age <18
  • Refused consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Capsule Endoscopy
Capsule Endoscopy examination of small intestine
Procedure: capsule endoscopy
capsule endoscopy of small intestine
Other: Mesenteric Angiogram
Mesenteric Angiogram of the small intestine
Procedure: Mesenteric Angiogram
Mesenteric Angiogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnostic yield of CE and mesenteric angiogram as the primary investigation after negative EGD and colonoscopy.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with definitive diagnoses achieved;Length of stay (days) ;Transfusion requirements;No. of additional investigations (endoscopies, radiological investigation, CE etc);No. of patients requiring surgery ;12-month rebleeding rate
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Wai K Leung, MD, CUHK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

May 13, 2008

Last Update Submitted That Met QC Criteria

May 9, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE_Ang

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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