Single Balloon Enterosocpy Obscure Gastrointestinal Bleeding Bleed

Obscure Gastrointestinal Bleeding Clinical Trial

Official title:

LONG-TERM OUTCOMES AFTER SINGLE-BALLOON ENTEROSCOPY IN PATIENTS WITH OBSCURE GASTROINTESTINAL BLEEDING

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625585
• Other study ID #: SBEWashU 2012
• Status: Completed
• Phase: N/A
• First received: June 19, 2012
• Last updated: October 14, 2013
• Start date: May 2011

Study information

• Verified date: October 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Obscure Gastrointestinal Bleeding

Locations

Country	Name	City	State
United States	Barnes Jewish Hospital/ Washington University	St Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of obscure gastrointestinal bleeding following single balloon enteroscopy	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.	4 years	No