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Completed

NCT Number: NCT00164853

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Endoscopy Center, Prince of Wales Hospital

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoscopic balloon dilatation

Procedure

Refer to description under arms

Standard sphincterotomy

Procedure

Refer to under arms

Primary outcomes

  1. stone clearance rate at the index session

    Time frame: 24 hours

    The ability to achieve complete stone clearance on the first ERCP

Secondary outcomes

  1. Number of ERCP's required to achieve stone clearance

    Time frame: 3 months

    The number of ERCP procedures required to achieve complete stone clearance in the bile duct

  2. ERCP related complications

    Time frame: 30 days

    These include complications that were described in consensus published in 1991

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2011
First posted
Sep 14, 2005
Registry last updated
Feb 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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