Single Balloon Enterosocpy Obscure Gastrointestinal Bleeding Bleed

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01625585
First received: June 19, 2012
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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
Obscure Gastrointestinal Bleeding

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: LONG-TERM OUTCOMES AFTER SINGLE-BALLOON ENTEROSCOPY IN PATIENTS WITH OBSCURE GASTROINTESTINAL BLEEDING

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Recurrence of obscure gastrointestinal bleeding following single balloon enteroscopy [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 147
Study Start Date: May 2011
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Consecutive patients undergoing SBE for OGIB

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.

  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

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625585

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

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01625585     History of Changes
Other Study ID Numbers: SBEWashU 2012
Study First Received: June 19, 2012
Last Updated: October 14, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 24, 2014