Single Balloon Enterosocpy Obscure Gastrointestinal Bleeding Bleed
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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 |
- 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 |
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.
Contacts and Locations 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: | June 21, 2012 |
| 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 May 19, 2013