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Single-Operator Versus Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders (DBE)

Primary Purpose

Small-Bowel Disorders

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Single-operator double-balloon endoscopy
dual-operator double-balloon endoscopy
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 double-balloon endoscopy, diagnostic yield

Eligibility Criteria

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

Inclusion Criteria:

  1. suspected or known small-bowel disease
  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

Single-operator DBE

Dual-operator DBE

Arm Description

Single-operator double-balloon endoscopy

Dual-operator double-balloon endoscopy

Outcomes

Primary Outcome Measures

completion whether the complete enteroscopy is achieved?
The completion rate for examination of the entire small intestine
lesion-discovery
lesion-discovery rate

Secondary Outcome Measures

observation time
Number of Participants with Adverse Events

Full Information

First Posted
August 16, 2010
Last Updated
August 18, 2010
Sponsor
Shanghai Changzheng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01184690
Brief Title
Single-Operator Versus Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders
Acronym
DBE
Official Title
Prospective Trial Comparing Single-Operator and Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
August 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shanghai Changzheng Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Double-balloon endoscopy (DBE) is a new device that allows diagnosis and treatment throughout the entire small intestine. Although the originally described method requires two operators, the investigators have recently developed a method to perform DBE by a single operator. The investigators here assessed the clinical usefulness of this one-person method in comparison to the conventional two-person DBE.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small-Bowel Disorders
Keywords
double-balloon endoscopy, diagnostic yield

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Single-operator DBE
Arm Type
Active Comparator
Arm Description
Single-operator double-balloon endoscopy
Arm Title
Dual-operator DBE
Arm Type
Active Comparator
Arm Description
Dual-operator double-balloon endoscopy
Intervention Type
Procedure
Intervention Name(s)
Single-operator double-balloon endoscopy
Intervention Description
Single-operator double-balloon endoscopy
Intervention Type
Procedure
Intervention Name(s)
dual-operator double-balloon endoscopy
Intervention Description
dual-operator double-balloon endoscopy
Primary Outcome Measure Information:
Title
completion whether the complete enteroscopy is achieved?
Description
The completion rate for examination of the entire small intestine
Time Frame
2 hours
Title
lesion-discovery
Description
lesion-discovery rate
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
observation time
Time Frame
2 hours
Title
Number of Participants with Adverse Events
Time Frame
2 days

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 disease 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
18819060
Citation
Araki A, Tsuchiya K, Okada E, Suzuki S, Oshima S, Okamoto R, Kanai T, Watanabe M. Single-operator method for double-balloon endoscopy: a pilot study. Endoscopy. 2008 Nov;40(11):936-8. doi: 10.1055/s-2008-1077545. Epub 2008 Sep 25.
Results Reference
result
PubMed Identifier
19220668
Citation
Araki A, Tsuchiya K, Okada E, Suzuki S, Oshima S, Yoshioka S, Yoshioka A, Kanai T, Watanabe M. Single-operator double-balloon endoscopy (DBE) is as effective as dual-operator DBE. J Gastroenterol Hepatol. 2009 May;24(5):770-5. doi: 10.1111/j.1440-1746.2009.05787.x. Epub 2009 Feb 12.
Results Reference
result

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Single-Operator Versus Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders

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