Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292331
Status:
COMPLETED
Last Update Posted:
2006-02-15
First Post:
2006-02-14
Brief Title:
N-Butyl-2-Cyanoacrylate Injection Versus Band Ligation for Gastric Variceal Hemorrhage
Sponsor:
Taipei Veterans General Hospital Taiwan
Organization:
Taipei Veterans General Hospital Taiwan
Study Overview
Official Title:
A Randomized Trial of Endoscopic Treatment of Acute Gastric Variceal Hemorrhage N-Butyl-2-Cyanoacrylate Injection Versus Band Ligation
Status:
COMPLETED
Status Verified Date:
2006-02
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:
The purpose of this study was to test the hypothesis by comparing the efficacy of cyanoacrylate injection GVO and band ligation GVL in the treatment of acute GVH in liver cirrhotic patients with or without concomitant hepatocellular carcinoma HCC
Detailed Description:
Gastric variceal hemorrhage GVH has a poorer prognosis than esophageal variceal hemorrhage However data on its optimal treatment are limited We designed a prospective study to compare the efficacy of endoscopic band ligation GVL and endoscopic N-butyl-2-cyanoacrylate injection GVO Liver cirrhotic patients with or without concomitant hepatocelluar carcinoma HCC and patients presenting with acute GVH were randomized into two treatment groups Forty-eight patients received GVL and another 49 patients received GVO Both treatments were equally successful in controlling active bleeding 1415 vs 1415 P 1000 More of the patients who underwent GVL had GV rebleeding GVL vs GVO 2148 vs 1149 P 044 The 2-year and 3-year cumulative rate of GV rebleeding were 631 95 confidence interval CI 445-817 723 95 CI 513-933 for GVL and 268 95 CI 125-411 268 95 CI 125-411 for GVO P 0143 log-rank test The rebleeding risk of GVL sustained throughout the entire follow-up period Multivariate Cox regression indicated that concomitance with HCC relative hazard 2453 95 CI 1036-5806 P 041 and the treatment method GVL vs GVO relative hazard 2660 95 CI 1167-6061 P 020 were independent factors predictive of GV rebleeding There was no difference in survival between the two groups Severe complications due to these two treatments were rare In conclusion the efficacy of GVL to control active GVH appears to have no difference with GVO but GVO is associated with a lower GV rebleeding 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