Single Balloon Enterosocpy Obscure Gastrointestinal Bleeding Bleed

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01625585
Recruitment Status : Completed
First Posted : June 21, 2012
Last Update Posted : October 16, 2013
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
The goal of the present study is to investigate the clinical outcomes of patients with gastrointestinal bleeding originating from the small intestine following diagnostic investigation with single balloon enteroscopy. We hypothesize that single balloon enteroscopy can arrive at a diagnosis and provide therapeutics in a majority of patients with gastrointestinal bleeding originating in the small intestine.

Condition or disease
Obscure Gastrointestinal Bleeding

Detailed Description:
The small intestine has been, until recent years, a black box to gastroenterologists because it is difficult to see and reach. Radiological imaging provides little details of small intestinal mucosa. Capsule endoscopy, introduced in 2001, enables gastroenterologists to visualize the entire small intestine from within for the first time, but it is only a diagnostic tool. Single-balloon enteroscopy (SBE) is a new enteroscopy methods that use an overtube with one balloon or a spiral to help pleat bowel onto the endoscope and allow examination of the distal small bowel. This methods allow for biopsy, hemostasis, and other therapeutic interventions to be performed in the small bowel. Early reports have been promising; with 50-70% diagnostic yield for small bowel pathology reported in the literature. However, despite these promising results the impact SBE findings on patient outcomes is not clear.

Study Type : Observational
Actual Enrollment : 147 participants
Observational Model: Cohort
Study Start Date : May 2011
Actual Primary Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Consecutive patients undergoing SBE for OGIB

Primary Outcome Measures :
  1. Recurrence of obscure gastrointestinal bleeding following single balloon enteroscopy [ Time Frame: 4 years ]
    The primary outcome is recurrence of gastrointestinal bleeding, defined as recurrent overt or occult gastrointestinal bleeding, hospitalization for gastrointestinal bleeding or acute blood loss anemia.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who underwent SBE at Washington University Medical Center/ Barnes Jewish Hospital prior to 1/1/2011 were eligible for inclusion. There was no control group as this was a retrospective cohort study.

Inclusion Criteria:

  • Patients with Obscure Gastrointestinal Bleeding undergoing SBE at Barnes Jewish Hospital

Exclusion Criteria:

  • Less than 3 months of follow up after SBE
  • The endoscope could not be advanced into the duodenum will be excluded.

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 identifier (NCT number): NCT01625585

United States, Missouri
Barnes Jewish Hospital/ Washington University
St Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine

Responsible Party: Washington University School of Medicine Identifier: NCT01625585     History of Changes
Other Study ID Numbers: SBEWashU 2012
First Posted: June 21, 2012    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013

Keywords provided by Washington University School of Medicine:
Push-and-Pull Enteroscopy

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