Double- Versus Single-balloon Enteroscopy for Obscure Small-bowel Bleeding (DBE;SBE)
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|ClinicalTrials.gov Identifier: NCT01176864|
Recruitment Status : Unknown
Verified July 2010 by Shanghai Changzheng Hospital.
Recruitment status was: Enrolling by invitation
First Posted : August 6, 2010
Last Update Posted : August 6, 2010
|Condition or disease||Intervention/treatment||Phase|
|Small-Bowel Disorders||Procedure: Double-balloon enteroscopy Procedure: Single-balloon enteroscopy||Phase 4|
Th e double-balloon enteroscopy (DBE) system, developed by Dr Yamamoto, was presented for the fi rst time in Japan in 2001. The system has become established throughout the world for diagnostic and therapeutic small-bowel examinations, and it is now used universally in routine clinical work.
Another balloon enteroscopy system was recently introduced in which only one balloon is attached at the tip of the overtube; the method is therefore known as SBE. SBE is a simplification of the double balloon method, and its value has already been confirmed for difficult colonoscopies. The question of whether similar results can be achieved with the single balloon method in the more complex situation of the small bowel has not yet been answered.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Prospective Trial Comparing Push-and-Pull Enteroscopy With the Single- and Double-Balloon Techniques in Patients With Obscure Small-Bowel Bleeding|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||July 2012|
|Estimated Study Completion Date :||July 2012|
Active Comparator: Double-balloon enteroscopy
DBE for suspected or known small-bowel bleeding
Procedure: Double-balloon enteroscopy
Active Comparator: Single-balloon enteroscopy
SBE for suspected or known small-bowel bleeding
Procedure: Single-balloon enteroscopy
- whether the complete enteroscopy is achieved? [ Time Frame: 2 hours ]the rate of complete enteroscopy in both groups.
- Preparation time [ Time Frame: 2 hours ]
- Investigation time [ Time Frame: 2 hours ]
- side effects [ Time Frame: 2 days ]
- Diagnostic yield [ Time Frame: 2 hours ]
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 ClinicalTrials.gov identifier (NCT number): NCT01176864
|Shanghai changzheng Hospital|
|Shanghai, Shanghai, China, 200003|
|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|