Double- Versus Single-balloon Enteroscopy for Obscure Small-bowel Bleeding
DBE;SBE
Prospective Trial Comparing Push-and-Pull Enteroscopy With the Single- and Double-Balloon Techniques in Patients With Obscure Small-Bowel Bleeding
1 other identifier
interventional
100
1 country
1
Brief Summary
Double-balloon enteroscopy (DBE) is now an established method for diagnostic and therapeutic small-bowel endoscopy. Single-balloon enteroscopy (SBE) has been introduced to simplify the technique. A prospective randomized study was carried out to compare the two methods in obscure small bowel bleeding
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 28, 2010
CompletedFirst Posted
Study publicly available on registry
August 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedAugust 6, 2010
July 1, 2010
2 years
July 28, 2010
August 5, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
whether the complete enteroscopy is achieved?
the rate of complete enteroscopy in both groups.
2 hours
Secondary Outcomes (4)
Preparation time
2 hours
Investigation time
2 hours
side effects
2 days
Diagnostic yield
2 hours
Study Arms (2)
Double-balloon enteroscopy
ACTIVE COMPARATORDBE for suspected or known small-bowel bleeding
Single-balloon enteroscopy
ACTIVE COMPARATORSBE for suspected or known small-bowel bleeding
Interventions
Eligibility Criteria
You may qualify if:
- suspected or known small-bowel bleeding
- age: 16-70
You may not qualify if:
- pregnancy
- coagulation disorders
- prior surgery of the small bowel and colon
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai changzheng Hospital
Shanghai, Shanghai Municipality, 200003, China
Related Publications (2)
Frantz DJ, Dellon ES, Grimm IS, Morgan DR. Single-balloon enteroscopy: results from an initial experience at a U.S. tertiary-care center. Gastrointest Endosc. 2010 Aug;72(2):422-6. doi: 10.1016/j.gie.2010.03.1117. Epub 2010 Jun 11.
PMID: 20541189BACKGROUNDMay A, Farber M, Aschmoneit I, Pohl J, Manner H, Lotterer E, Moschler O, Kunz J, Gossner L, Monkemuller K, Ell C. Prospective multicenter trial comparing push-and-pull enteroscopy with the single- and double-balloon techniques in patients with small-bowel disorders. Am J Gastroenterol. 2010 Mar;105(3):575-81. doi: 10.1038/ajg.2009.712. Epub 2010 Jan 5.
PMID: 20051942RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jian Shi, MD
Shanghai Changzheng Hospital
- PRINCIPAL INVESTIGATOR
Bin Shi, MD
Shanghai Changzheng Hospital
- STUDY DIRECTOR
Wei-Fen Xie, MD
Shanghai Changzheng Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 28, 2010
First Posted
August 6, 2010
Study Start
July 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
August 6, 2010
Record last verified: 2010-07