Single-Operator Versus Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders
DBE
Prospective Trial Comparing Single-Operator and Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2010
Shorter than P25 for phase_4
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
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 16, 2010
CompletedFirst Posted
Study publicly available on registry
August 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedAugust 19, 2010
August 1, 2010
1 year
August 16, 2010
August 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
completion whether the complete enteroscopy is achieved?
The completion rate for examination of the entire small intestine
2 hours
lesion-discovery
lesion-discovery rate
2 hours
Secondary Outcomes (2)
observation time
2 hours
Number of Participants with Adverse Events
2 days
Study Arms (2)
Single-operator DBE
ACTIVE COMPARATORSingle-operator double-balloon endoscopy
Dual-operator DBE
ACTIVE COMPARATORDual-operator double-balloon endoscopy
Interventions
Single-operator double-balloon endoscopy
dual-operator double-balloon endoscopy
Eligibility Criteria
You may qualify if:
- suspected or known small-bowel disease
- 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)
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.
PMID: 18819060RESULTAraki 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.
PMID: 19220668RESULT
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
August 16, 2010
First Posted
August 19, 2010
Study Start
August 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
August 19, 2010
Record last verified: 2010-08