Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00371943
Status:
TERMINATED
Last Update Posted:
2006-09-15
First Post:
2006-09-01
Brief Title:
EVL Plus Drug to Prevent Variceal Rebleeding
Sponsor:
National Science Council Taiwan
Organization:
National Science Council Taiwan
Study Overview
Official Title:
A Controlled Trial of Ligation Plus Drug Vs Drug Alone in the Prevention of Variceal Rebleeding
Status:
TERMINATED
Status Verified Date:
2006-09
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:
Both medications with beta-blockers and isosorbide-5-mononitrate and endoscopic variceal ligation have been proven plausible in the prevention of variceal rebleeding However the relative efficacy and safety of the combined treatment for preventing rebleeding remains unresolved
Detailed Description:
Bleeding from esophageal varices is a severe complication of portal hypertension After initial control of acute variceal bleeding patients still carry a high risk of rebleeding Of those do rebleed there is a 20-35 mortality 1 Therefore preventive procedures are required in patients surviving an episode of acute variceal bleeding In recent years endoscopic variceal ligation EVL has replaced endoscopic injection sclerotherapy EIS as the endoscopic treatment of choice in the management of bleeding esophageal varices 2-3 On the other hand nonselective beta blockers have been well documented to be effective in reducing variceal rebleeding 4-5 The addition of isosorbide-5-mononitrate ISMN has been shown to be even more effective than propranolol alone in the reduction of portal pressure and in the prevention of variceal rebleeding 6 Some studies showed that the combination of nadolol and ISMN is more effective than EIS or EVL in the reduction of variceal rebleeding 7-8 It is still unknown whether EVL combined with nadolol and ISMN is superior to nadolol and ISMN in the prevention of variceal rebleeding This study was undertaken to compare the effectiveness and complications of ligation plus nadolol and isosorbide mononitrate vs nadolol plus isosorbide mononitrate for the prevention of variceal rebleeding
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