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Double- Versus Single-balloon Enteroscopy for Obscure Small-bowel Bleeding (DBE;SBE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Shanghai Changzheng Hospital

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

Condition or disease Intervention/treatment Phase
Small-Bowel Disorders Procedure: Double-balloon enteroscopy Procedure: Single-balloon enteroscopy Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: Double-balloon enteroscopy
DBE for suspected or known small-bowel bleeding
Procedure: Double-balloon enteroscopy
Double-balloon enteroscopy

Active Comparator: Single-balloon enteroscopy
SBE for suspected or known small-bowel bleeding
Procedure: Single-balloon enteroscopy
Single-balloon enteroscopy

Primary Outcome Measures :
  1. whether the complete enteroscopy is achieved? [ Time Frame: 2 hours ]
    the rate of complete enteroscopy in both groups.

Secondary Outcome Measures :
  1. Preparation time [ Time Frame: 2 hours ]
  2. Investigation time [ Time Frame: 2 hours ]
  3. side effects [ Time Frame: 2 days ]
  4. Diagnostic yield [ Time Frame: 2 hours ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. suspected or known small-bowel bleeding
  2. age: 16-70

Exclusion Criteria:

  1. pregnancy
  2. coagulation disorders
  3. prior surgery of the small bowel and colon

Information from the National Library of Medicine

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 identifier (NCT number): NCT01176864

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China, Shanghai
Shanghai changzheng Hospital
Shanghai, Shanghai, China, 200003
Sponsors and Collaborators
Shanghai Changzheng Hospital
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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
Publications of Results:
Other Publications:
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Responsible Party: Jian Shi, Shanghai Changzheng Hospital Identifier: NCT01176864    
Other Study ID Numbers: ERK-2
First Posted: August 6, 2010    Key Record Dates
Last Update Posted: August 6, 2010
Last Verified: July 2010
Keywords provided by Shanghai Changzheng Hospital:
Small-Bowel Disorders
Double-balloon enteroscopy
Single-balloon enteroscopy
Additional relevant MeSH terms:
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Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases