Clinical trial NCT00164853: Compare Combined Sphincterotomy and Balloon Dilation (ESBD) Versus Standard Sphincterotomy (ES) in Removing Biliary Stones
Official title: Combined Sphincterotomy and Balloon Dilation (ESBD) Versus Standard Sphincterotomy (ES) in Removing Biliary Stones-a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Common Bile Duct Stone
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 hypothesize that combined balloon dilation and sphincterotomy allows for easier stone removal without added morbidities when compared to standard sphincterotomy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: stone clearance rate at the index session
timeFrame: 24 hours
Secondary outcomes:
measure: Number of ERCP's required to achieve stone clearance
timeFrame: 3 months
measure: ERCP related complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Endoscopy Center, Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Frances KY Cheung, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Teoh AYB, Cheung FKY, Hu B, Pan YM, Lai LH, Chiu PWY, Wong SKH, Chan FKL, Lau JYW. Randomized trial of endoscopic sphincterotomy with balloon dilation versus endoscopic sphincterotomy alone for removal of bile duct stones. Gastroenterology. 2013 Feb;144(2):341-345.e1. doi: 10.1053/j.gastro.2012.10.027. Epub 2012 Oct 17.