Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164853
Status:
COMPLETED
Last Update Posted:
2012-02-17
First Post:
2005-09-11
Brief Title:
Compare Combined Sphincterotomy and Balloon Dilation ESBD Versus Standard Sphincterotomy ES in Removing Biliary Stones
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Combined Sphincterotomy and Balloon Dilation ESBD Versus Standard Sphincterotomy ES in Removing Biliary Stones-a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None