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Sponsored by: |
National Taiwan University Hospital |
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Information provided by: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00451581 |
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.
Condition | Intervention |
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Choledocholithiasis |
Procedure: Endoscopic papillary balloon dilation-5 minutes Procedure: Endoscopic papillary balloon dilation-1 minute |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective Randomized Multicenter Study Comparing Different Dilation Durations During Endoscopic Papillary Balloon Dilatation for Bile Duct Stones. |
Estimated Enrollment: | 160 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | January 2008 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Wei-Chih Liao, MD | 886-2-23123456 ext 3356 | david.ntuh@msa.hinet.net |
Taiwan | |
National Taiwan University Hospital | Recruiting |
Taipei, Taiwan, 100 | |
Principal Investigator: Wei-Chih Liao, MD |
Principal Investigator: | Wei-Chih Liao, MD | National Taiwan University Hospital |
Study ID Numbers: | 9561709036 |
Study First Received: | March 22, 2007 |
Last Updated: | March 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00451581 |
Health Authority: | Taiwan: Department of Health |
Endoscopic papillary balloon dilatation Endoscopic sphincterotomy Choledocholithiasis Efficacy Complication |
Cholecystolithiasis Cholelithiasis Digestive System Diseases Dilatation, Pathologic Gallstones |
Bile Duct Diseases Biliary Tract Diseases Calculi Choledocholithiasis |
Common Bile Duct Diseases |