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

Common Bile Duct Stone Clinical Trial

Official title:

Combined Sphincterotomy and Balloon Dilation (ESBD) Versus Standard Sphincterotomy (ES) in Removing Biliary Stones—a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164853
• Other study ID #: CRE-2005.067-T
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2005
• Last updated: February 16, 2012
• Start date: September 2005

Study information

• Verified date: September 2010
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Common Bile Duct Stone
• Gallstones

Intervention

Procedure:
• endoscopic balloon dilatation
Refer to description under arms
• Standard sphincterotomy
Refer to under arms

Locations

Country	Name	City	State
China	Endoscopy Center, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stone clearance rate at the index session	The ability to achieve complete stone clearance on the first ERCP	24 hours	Yes
Secondary	Number of ERCP's required to achieve stone clearance	The number of ERCP procedures required to achieve complete stone clearance in the bile duct	3 months	No
Secondary	ERCP related complications	These include complications that were described in consensus published in 1991	30 days	Yes