Compare Combined Sphincterotomy and Balloon Dilation (ESBD) Versus Standard Sphincterotomy (ES) in Removing Biliary Stones

Phase 3

Completed

• Conditions: Common Bile Duct Stone
• Interventions: Procedure: Standard sphincterotomy; Procedure: endoscopic balloon dilatation

• Registration Number: NCT00164853
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-14
• Status Verified: 2010-09
• Primary Completion: 2011-09
• Last Update Submitted: 2012-02-16
• Last Update Posted: 2012-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard sphincterotomy (ES)	Standard sphincterotomy	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.
Sphincterotomy plus balloon dilation (ESBD)	endoscopic balloon dilatation	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.

Primary Outcome Measures

Name	Time	Method
stone clearance rate at the index session	24 hours	The ability to achieve complete stone clearance on the first ERCP

Secondary Outcome Measures

Name	Time	Method
Number of ERCP's required to achieve stone clearance	3 months	The number of ERCP procedures required to achieve complete stone clearance in the bile duct
ERCP related complications	30 days	These include complications that were described in consensus published in 1991

Trial Locations

Locations (1)

Endoscopy Center, Prince of Wales Hospital; 🇨🇳 Hong Kong, China