Clinical Trial: A Prospective Randomized Study Comparing Different Dilation Durations for Endoscopic Papillary Balloon Dilatation
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Prospective Randomized Multicenter Study Comparing Different Dilation Durations During Endoscopic Papillary Balloon Dilatation for Bile Duct Stones.
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: National Taiwan University Hospital
Current Primary Outcome: need of switching to sphincterotomy
Original Primary Outcome: Same as current
Current Secondary Outcome:
- efficacy of lithotripsy
- post-ERCP complications
Original Secondary Outcome: Same as current
Information By: National Taiwan University Hospital
Dates:
Date Received: March 22, 2007
Date Started: January 2007
Date Completion: January 2008
Last Updated: March 22, 2007
Last Verified: October 2006
