Ignite Creation Date:
2024-05-05 @ 10:28 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01112852
Status:
COMPLETED
Last Update Posted:
2010-04-28
First Post:
2010-04-23
Brief Title:
EVL Endoscopic Variceal Ligation Plus Vasoconstrictor vsLigation Plus PPI Proton Pump Inhibitor in the Control of Acute Esophageal Variceal Bleeding
Sponsor:
National Science Council Taiwan
Organization:
National Science Council Taiwan
Study Overview
Official Title:
A Randomized Controlled Trial of Ligation Plus Vasoconstrictor vsLigation Plus Proton Pump Inhibitor in the Control of Acute Esophageal Variceal Bleeding
Status:
COMPLETED
Status Verified Date:
2010-04
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:
EVL
Brief Summary:
Previous studies showed that combination of endoscopic therapy with vasoconstrictor is better than either vasoconstrictor or endoscopic therapy alone in achieving the successful hemostatsis of acute variceal bleeding The rationale of using vasoconstrictor is to enhance the efficacy of hemostasis by endoscopic therapy Nowadays endoscopic variceal ligation EVL has replaced endoscopic injection sclerotherapy EIS as the endoscopic treatment of choice in the arresting of acute esophageal variceal hemorrhage EVL alone can achieve hemotasis up to 97 even in cases of active variceal hemorrhage However early rebleeding due to ligation-induced ulcer may be encountered It appears that prevention of esophageal ulcers and bleeding by a proton pump inhibitor may be more logical than using a vasoconstrictor after cessation of bleeding by EVL
Detailed Description:
Previous studies showed that combination of endoscopic therapy with vasoconstrictor is better than either vasoconstrictor or endoscopic therapy alone in achieving the successful hemostatsis of acute variceal bleeding The rationale of using vasoconstrictor is to enhance the efficacy of hemostasis by endoscopic therapy Nowadays endoscopic variceal ligation EVL has replaced endoscopic injection sclerotherapy EIS as the endoscopic treatment of choice in the arresting of acute esophageal variceal hemorrhage EVL alone can achieve hemotasis up to 97 even in cases of active variceal hemorrhage However early rebleeding due to ligation-induced ulcer may be encountered It appears that prevention of esophageal ulcers and bleeding by a proton pump inhibitor may be more logical than using a vasoconstrictor after cessation of bleeding by EVL
Thus we designed a controlled trial to compare the initial hemostasis early rebleeding rate in cirrhotic patients presenting with acute variceal bleeding receiving either emergency EVL plus somatostatin infusion or losec infusion for 5 days
AIMS
To investigate whether the combination of EVL and somatostatin is superior to the combination of EVL and losec in terms of efficacy in the arresting of acute esophageal variceal bleeding and very early rebleeding
Thus we designed a controlled trial to compare the initial hemostasis early rebleeding rate in cirrhotic patients presenting with acute variceal bleeding receiving either emergency EVL plus somatostatin infusion or losec infusion for 5 days
AIMS
To investigate whether the combination of EVL and somatostatin is superior to the combination of EVL and losec in terms of efficacy in the arresting of acute esophageal variceal bleeding and very early 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PPI for EVB | OTHER_GRANT | Taiwan National Science Council | None |