Ignite Creation Date:
2024-05-06 @ 1:42 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01873079
Status:
COMPLETED
Last Update Posted:
2016-07-18
First Post:
2013-06-05
Brief Title:
PPI for Prevention of Post-sphincterotomy Bleeding
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Prevention of Delayed Post-sphincterotomy Bleeding by High Dose Proton Pump Inhibitor
Status:
COMPLETED
Status Verified Date:
2016-07
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:
Endoscopic biliary sphincterotomy is a common and important procedure for biliary access and therapy during endoscopic retrograde cholangiopancreatography ERCP Bleeding is one of the important complications related to sphincterotomy This study determines the role of proton pump inhibitor PPI in preventing post-sphincterotomy bleeding in patients undergoing ERCP and sphincterotomy
Detailed Description:
Eligible patients will be randomized to receive either high dose PPI or standard care PPI will be given before ERCP and continue for one week after the sphincterotomy
Both overt and occult bleeding will be documented up to 10 days after the sphincterotomy Bleeding rates of the two groups will be compared
Both overt and occult bleeding will be documented up to 10 days after the sphincterotomy Bleeding rates of the two groups will be compared
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