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Diagnostic Evaluation of Obscure Gastrointestinal Bleeding

This study is currently recruiting participants.
Verified by Massachusetts General Hospital, December 2007

Sponsored by: Massachusetts General Hospital
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00593021
  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

MedlinePlus related topics:   Endoscopy    Gastrointestinal Bleeding   

U.S. FDA Resources

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

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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   100
Study Start Date:   October 2007
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   August 2008 (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, hemetemesis, 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


Responsible Party:   Brigham and Women's Hospital ( John R. Saltzman, MD )
Study ID Numbers:   SALTZMAN: 2007P-000991
First Received:   December 28, 2007
Last Updated:   December 28, 2007
ClinicalTrials.gov Identifier:   NCT00593021
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  

Study placed in the following topic categories:
Digestive System Diseases
Gastrointestinal Diseases
Gastrointestinal Hemorrhage
Hemorrhage

Additional relevant MeSH terms:
Pathologic Processes

ClinicalTrials.gov processed this record on November 30, 2008




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