Full Text View
Tabular View
No Study Results Posted
Related Studies
N-Butyl-2-Cyanoacrylate Injection Versus Band Ligation for Gastric Variceal Hemorrhage
This study has been completed.
Study NCT00292331   Information provided by Taipei Veterans General Hospital,Taiwan
First Received: February 14, 2006   No Changes Posted

February 14, 2006
February 14, 2006
 
 
Comparing the efficacy of cyanoacrylate injection (GVO) and band ligation (GVL) in the treatment of acute gastric variceal hemorrhage (GVH) in liver cirrhotic patients
Same as current
No Changes Posted
 
 
 
N-Butyl-2-Cyanoacrylate Injection Versus Band Ligation for Gastric Variceal Hemorrhage
A Randomized Trial of Endoscopic Treatment of Acute Gastric Variceal Hemorrhage: N-Butyl-2-Cyanoacrylate Injection Versus Band Ligation

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).

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 (14/15 vs. 14/15, P = 1.000). More of the patients who underwent GVL had GV rebleeding (GVL vs. GVO, 21/48 vs. 11/49; P = .044). The 2-year and 3-year cumulative rate of GV rebleeding were 63.1% (95% confidence interval [CI], 44.5%-81.7%), 72.3% (95% CI, 51.3%-93.3%) for GVL and 26.8% (95% CI, 12.5%-41.1%), 26.8% (95% CI, 12.5%-41.1%) 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: 2.453, 95% CI: 1.036-5.806, P = .041) and the treatment method (GVL vs. GVO, relative hazard: 2.660, 95% CI: 1.167-6.061, 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.

Phase III
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Gastric Variceal Hemorrhage
Procedure: cyanoacrylate injection to treat gastric variceal hemorrhage
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
120
 
 

Inclusion Criteria:

* Patients who were aged between 18 and 80 years and had endoscopy-proven acute gastric variceal hemorrhage (GVH)

Exclusion Criteria:

  • Cases with concomitant large GV and large EV, but without stigmata of recent bleeding
  • Cases had previous endoscopic, surgical treatment or transjugular intrahepatic portosystemic shunt for GVH
  • Cases had a terminal illness of any major organ system, like heart failure, uremia, chronic obstructive pulmonary disease, or nonhepatic malignancy
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00292331
 
VGH-88-B251
Taipei Veterans General Hospital,Taiwan
 
Principal Investigator: Ming-Chih Hou, M.D. Taipei Veterans General Hospital,Taiwan
Taipei Veterans General Hospital,Taiwan
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP