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

Primary Purpose

Small-Bowel Disorders

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Double-balloon enteroscopy
Single-balloon enteroscopy
Sponsored by
Shanghai Changzheng Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Small-Bowel Disorders focused on measuring Small-Bowel Disorders, Double-balloon enteroscopy, Single-balloon enteroscopy

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai changzheng Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Double-balloon enteroscopy

Single-balloon enteroscopy

Arm Description

DBE for suspected or known small-bowel bleeding

SBE for suspected or known small-bowel bleeding

Outcomes

Primary Outcome Measures

whether the complete enteroscopy is achieved?
the rate of complete enteroscopy in both groups.

Secondary Outcome Measures

Preparation time
Investigation time
side effects
Diagnostic yield

Full Information

First Posted
July 28, 2010
Last Updated
August 5, 2010
Sponsor
Shanghai Changzheng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01176864
Brief Title
Double- Versus Single-balloon Enteroscopy for Obscure Small-bowel Bleeding
Acronym
DBE;SBE
Official Title
Prospective Trial Comparing Push-and-Pull Enteroscopy With the Single- and Double-Balloon Techniques in Patients With Obscure Small-Bowel Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shanghai Changzheng Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small-Bowel Disorders
Keywords
Small-Bowel Disorders, Double-balloon enteroscopy, Single-balloon enteroscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Double-balloon enteroscopy
Arm Type
Active Comparator
Arm Description
DBE for suspected or known small-bowel bleeding
Arm Title
Single-balloon enteroscopy
Arm Type
Active Comparator
Arm Description
SBE for suspected or known small-bowel bleeding
Intervention Type
Procedure
Intervention Name(s)
Double-balloon enteroscopy
Intervention Description
Double-balloon enteroscopy
Intervention Type
Procedure
Intervention Name(s)
Single-balloon enteroscopy
Intervention Description
Single-balloon enteroscopy
Primary Outcome Measure Information:
Title
whether the complete enteroscopy is achieved?
Description
the rate of complete enteroscopy in both groups.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Preparation time
Time Frame
2 hours
Title
Investigation time
Time Frame
2 hours
Title
side effects
Time Frame
2 days
Title
Diagnostic yield
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: suspected or known small-bowel bleeding age: 16-70 Exclusion Criteria: pregnancy coagulation disorders prior surgery of the small bowel and colon
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Shi, MD
Organizational Affiliation
Shanghai Changzheng Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bin Shi, MD
Organizational Affiliation
Shanghai Changzheng Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei-Fen Xie, MD
Organizational Affiliation
Shanghai Changzheng Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai changzheng Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
20541189
Citation
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.
Results Reference
background
PubMed Identifier
20051942
Citation
May 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.
Results Reference
result

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Double- Versus Single-balloon Enteroscopy for Obscure Small-bowel Bleeding

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