Diagnostic Evaluation of Obscure Gastrointestinal Bleeding

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00593021
First received: December 28, 2007
Last updated: May 3, 2010
Last verified: April 2010
  Purpose

Up to 5% of patients with recurrent gastrointestinal (GI) bleeding remain undiagnosed by EGD and colonoscopy, the presumed source of bleeding in these patients being the small intestine. These patients fall under the category of "obscure gastrointestinal bleeding," and frequently require an extensive diagnostic work-up. For these reasons, most patients who present with obscure or occult gastrointestinal bleeding typically undergo multiple endoscopic evaluations, including capsule endoscopy and various radiologic imaging studies, including enteroclysis, small bowel series, CT scan, angiography, and radionuclide scan. Recently, many centers (included the Brigham and Women's Hospital) have begun using capsule endoscopy and CT enterography (CTE) for evaluation of suspected small bowel pathology. This is an observational study enrolling patients referred to the Brigham and Women's Hospital for obscure gastrointestinal bleeding designed to compare the diagnostic yield of various diagnostic modalities, in particular capsule endoscopy and CT enterography in the evaluation of obscure gastrointestinal bleeding.


Condition
Obscure Gastrointestinal Bleeding

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Diagnostic Evaluation of Obscure Gastrointestinal Bleeding

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Diagnostic yield of capsule endoscopy and CT Enterography in patients with obscure GI bleeding [ Time Frame: Continuous ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital course, clinical improvement [ Time Frame: 120 days from enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults over the age of 18 and able to give consent who are referred to the Brigham and Women's Hospital Endoscopy Center or GI Clinic for the evaluation of obscure gastrointestinal bleeding

Criteria

Inclusion Criteria:

  • Anemia, hematochezia, melena, Hematemesis, heme positive stool with negative EGD+/-colonoscopy

Exclusion Criteria:

  • Under the age of 18
  • Unable to give consent
  • IV Contrast Allergy (excluded from CT)
  • Renal insufficiency (excluded from CT)
  • Unable to swallow (excluded from capsule)
  • Small bowel obstruction or stricturing disease (excluded from capsule)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00593021

Contacts
Contact: Jaya R Agrawal, MD, MPH 617-525-8763 jagrawal@partners.org
Contact: John R Saltzman, MD 617-525-8763 jsaltzman@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jaya R Agrawal, MD, MPH     617-525-8763     jagrawal@partners.org    
Contact: John R Saltzman, MD     617-525-8763     jsaltzman@partners.org    
Sub-Investigator: Jaya R Agrawal, MD, MPH            
Principal Investigator: John R Saltzman, MD            
Sub-Investigator: Anne T Wolf, MD, MSc            
Sub-Investigator: Sarathchandra I Reddy, MD            
Sub-Investigator: Koenrad J Mortele, MD            
Sub-Investigator: Stuart G Silverman, MD            
Sub-Investigator: Rie Maurer, MA            
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: John R Saltzman, MD Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: John R. Saltzman, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00593021     History of Changes
Other Study ID Numbers: SALTZMAN: 2007P-000991
Study First Received: December 28, 2007
Last Updated: May 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Obscure Gastrointestinal Bleeding
Occult Gastrointestinal Bleeding
Overt Gastrointestinal Bleeding
Capsule Endoscopy
CT Enterography

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

ClinicalTrials.gov processed this record on May 19, 2013