A Prospective Randomized Study Comparing Different Dilation Durations for Endoscopic Papillary Balloon Dilatation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00451581
Recruitment Status : Unknown
Verified October 2006 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : March 23, 2007
Last Update Posted : March 23, 2007
Information provided by:
National Taiwan University Hospital

March 22, 2007
March 23, 2007
March 23, 2007
January 2007
Not Provided
need of switching to sphincterotomy
Same as current
No Changes Posted
  • efficacy of lithotripsy
  • post-ERCP complications
Same as current
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A Prospective Randomized Study Comparing Different Dilation Durations for Endoscopic Papillary Balloon Dilatation
A Prospective Randomized Multicenter Study Comparing Different Dilation Durations During Endoscopic Papillary Balloon Dilatation for Bile Duct Stones.
Endoscopic papillary balloon dilation is as effective as sphincterotomy in treating bile duct stone. However, a need to switch to sphincterotomy is noted in about 20% of cases receiving dilation for lithotripsy. It is hypothesized that a longer dilation duration (5 min. vs. 1 min.) can decrease the need of switching to sphincterotomy.
Endoscopic papillary balloon dilatation (EPBD) has been proposed as an alternative to endoscopic sphincterotomy (EST) for endoscopic treatment of common bile duct (CBD) stones. EPBD is as effective as EST in stone clearance with a lower risk of hemorrhage, and may preserve the function of sphincter of Oddi. However, it has been reported that about 20% of patients undergoing EPBD need EST as a rescue procedure for lithotripsy. A longer dilation duraton of 5 mintues as opposed to 1 minute has been proposed to decrease oozing after dilation and facilitate lithotripsy, and it is hypothesized that it will reduce the need of switching to EST.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Procedure: Endoscopic papillary balloon dilation-5 minutes
  • Procedure: Endoscopic papillary balloon dilation-1 minute
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
January 2008
Not Provided

Inclusion Criteria:

  • Patients undergoing endoscopic retrograde cholangiopancreatography for choledocholithiasis

Exclusion Criteria:

  • Consent not obtained.
  • No apparent stone.
  • Intradiverticular papilla.
  • Prior EST.
  • Bile duct stricture.
  • Pancreatic or biliary malignant disorders.
  • Intrahepatic stones.
  • Active acute pancreatitis.
  • Sphincter of Oddi dysfunction.
  • Pregnancy.
  • Primary sclerosing cholangitis or choledochocyst.
  • Previous biliary surgery other than cholecystectomy.
  • Stone impaction at ampulla.
  • Precut for cannulation.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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National Taiwan University Hospital
Not Provided
Principal Investigator: Wei-Chih Liao, MD National Taiwan University Hospital
National Taiwan University Hospital
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP