Compare Combined Sphincterotomy and Balloon Dilation (ESBD) Versus Standard Sphincterotomy (ES) in Removing Biliary Stones
February 16, 2012 updated by: Chinese University of Hong Kong
Combined Sphincterotomy and Balloon Dilation (ESBD) Versus Standard Sphincterotomy (ES) in Removing Biliary Stones-a Randomized Controlled Trial
To compare the technique of combined balloon sphincter dilation after an initial sphincterotomy and standard sphincterotomy in the endoscopic removal of large bile duct stones.
The investigators hypothesize that combined balloon dilation and sphincterotomy allows for easier stone removal without added morbidities when compared to standard sphincterotomy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Endoscopic sphincterotomy is a standard technique to enlarge the bile duct opening before stone removal during endoscopic retrograde cholangiopancreatography.
However, complete sphincter ablation by endoscopic sphincterotomy is not always possible.
Also, due to the tapering end of the distal duct, standard sphincterotomy may not be adequate for removal of particularly large stones.
In a retrospective series by Ersoz et al, the addition of balloon dilation after sphincterotomy achieves a high stone clearance rate (89-95%).
The investigators postulate that the combination of endoscopic sphincterotomy followed by balloon dilation may allow easier stone retrieval with acceptable complication rate.
Study Type
Interventional
Enrollment (Actual)
180
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, China
- Endoscopy Center, Prince of Wales Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients at least 18 years old, presented to Prince of Wales Hospital for endoscopic retrograde cholangiopancreatography (ERCP) for known or suspected bile duct stones are invited to participate.
- Informed consent will be obtained before the beginning of ERCP.
- Patients are randomized to EST or ESBD after confirming the presence of bile duct stones on the initial cholangiogram
Exclusion Criteria:
- septic shock, coagulopathy (international normalized ratio >1.3,
- partial thromboplastin time greater than twice that of control),
- platelet count <50,000x103/uL or
- ampullary tumors
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Standard sphincterotomy (ES)
After deep cannulation, a pull-type sphincterotomy will be performed with a 25mm sphincterotome (eg clever cut, Olympus, Tokyo, Japan) with division of sphincter up to the duodenal wall.
A complete sphincterotomy is defined by the free passage of a fully bowed sphincterotome with a 25m wire and spontaneous bile drainage.
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Refer to under arms
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Active Comparator: Sphincterotomy plus balloon dilation (ESBD)
After complete sphincterotomy, a 3-cm long 15mm diameter CRE balloon is passed over a guidewire across the lower end of common bile duct.
The contrast filled balloon is inflated to the size of the bile duct for around 30 seconds until waisting is abolished.
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Refer to description under arms
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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stone clearance rate at the index session
Time Frame: 24 hours
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The ability to achieve complete stone clearance on the first ERCP
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24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of ERCP's required to achieve stone clearance
Time Frame: 3 months
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The number of ERCP procedures required to achieve complete stone clearance in the bile duct
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3 months
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ERCP related complications
Time Frame: 30 days
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These include complications that were described in consensus published in 1991
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30 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Frances KY Cheung, MBChB, Chinese University of Hong Kong
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
September 11, 2005
First Submitted That Met QC Criteria
September 11, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
February 17, 2012
Last Update Submitted That Met QC Criteria
February 16, 2012
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRE-2005.067-T
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