Endoscopy Center, Prince of Wales Hospital
Hong Kong, China
NCT Number: NCT00164853
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Hong Kong, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Refer to description under arms
Refer to under arms
Time frame: 24 hours
The ability to achieve complete stone clearance on the first ERCP
Time frame: 3 months
The number of ERCP procedures required to achieve complete stone clearance in the bile duct
Time frame: 30 days
These include complications that were described in consensus published in 1991
Chinese University of Hong Kong
Other
Combined Sphincterotomy and Balloon Dilation (ESBD) Versus Standard Sphincterotomy (ES) in Removing Biliary Stones-a Randomized Controlled Trial
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