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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00451581
First received: March 22, 2007
Last updated: NA
Last verified: October 2006
History: No changes posted

March 22, 2007
March 22, 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
Not Provided
Not Provided
 
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Choledocholithiasis
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
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.
Both
18 Years and older
No
Contact: Wei-Chih Liao, MD 886-2-23123456 ext 3356 david.ntuh@msa.hinet.net
Taiwan
 
NCT00451581
9561709036
Not Provided
Not Provided
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