Status:
COMPLETED
Compare Combined Sphincterotomy and Balloon Dilation (ESBD) Versus Standard Sphincterotomy (ES) in Removing Biliary Stones
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Common Bile Duct Stone
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 hypot...
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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00164853
Start Date
September 1 2005
Last Update
February 17 2012
Active Locations (1)
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1
Endoscopy Center, Prince of Wales Hospital
Hong Kong, China