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

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ClinicalTrials.gov Identifier: NCT00164853
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : February 17, 2012
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Common Bile Duct Stone Procedure: endoscopic balloon dilatation Procedure: Standard sphincterotomy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Sphincterotomy and Balloon Dilation (ESBD) Versus Standard Sphincterotomy (ES) in Removing Biliary Stones-a Randomized Controlled Trial
Study Start Date : September 2005
Actual Primary Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones

Arm Intervention/treatment
Active Comparator: Standard sphincterotomy (ES)
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.
Procedure: Standard sphincterotomy
Refer to under arms

Active Comparator: Sphincterotomy plus balloon dilation (ESBD)
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.
Procedure: endoscopic balloon dilatation
Refer to description under arms




Primary Outcome Measures :
  1. stone clearance rate at the index session [ Time Frame: 24 hours ]
    The ability to achieve complete stone clearance on the first ERCP


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164853


Locations
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China
Endoscopy Center, Prince of Wales Hospital
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Frances KY Cheung, MBChB Chinese University of Hong Kong
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anthony Yuen Bun Teoh, Department of Surgery, Chinese University of Hong Kong, Hong Kong
ClinicalTrials.gov Identifier: NCT00164853    
Other Study ID Numbers: CRE-2005.067-T
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: September 2010
Additional relevant MeSH terms:
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Cholelithiasis
Cholecystolithiasis
Gallstones
Calculi
Pathological Conditions, Anatomical
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases