A randomized trial of endoscopic treatment of acute gastric variceal hemorrhage: N-Butyl-2-Cyanoacrylate injection versus band ligation

Abstract

Progression of gastric variceal hemorrhage (GVH) is poorer than esophageal variceal bleeding. 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 patients with cirrhosis with or without concomitant hepatocellular 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% and 72.3% for GVL, and 26.8% for both periods with GVO; P ‫؍‬ .0143, log-rank test. The rebleeding risk of GVL was 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 attributable to these two treatments were rare. In conclusion, the efficacy of GVL to control active GVH appears not different to GVO, but GVO is associated with a lower GV rebleeding rate. (HEPATOLOGY 2006;43:690-697.) A lthough the outcome of variceal hemorrhage has improved over the past two decades, variceal hemorrhage is still the most serious complication of portal hypertension and chronic liver disease. 1 Although bleeding occurs less often from gastric varices (GV) than from esophageal varices (EV) (esophageal variceal hemorrhage [EVH] accounts for 70% to 80% of variceal hemorrhage), it has a poorer prognosis and is associated with more severe blood loss, a higher rebleeding rate, and a higher mortality rate. 1-3 However, limited data exist on the best treatment for GV hemorrhage (GVH). Endoscopic treatment is an alternative in the management of GVH and includes endoscopic injection of sclerosants or thrombin, 4,5 endoscopic band ligation, 6,7 and others. The success rate in controlling GVH by endoscopic injection of N-butyl-2-cyanoacrylate (GVO) appears higher than for other sclerosants according to previous non-randomized trials. 8,9 Though endoscopic variceal ligation is regarded as the optimal endoscopic treatment for EVH, 10 its safety and efficacy for the treatment of GVH is uncertain. 7,11 The rebleeding rate of GVO is variable and ranges from 10% to 42%. 12 At the time we started this trial, there were no randomized control trials, and even now, there is only one relatively small randomized clinical trial, 13 which was conducted to compare these two potential treatment modalities (endoscopic band ligation [GVL] vs. GVO) on the GVH; it showed results in favor of GVO for the treatment of GVH. We...

Gastric Varices in Cirrhosis versus Extrahepatic Portal Venous Obstruction and Response to Endoscopic N-Butyl-2-cyanoacrylate Injection

“…21 The preferred first line treatment for acute gastric variceal bleeding is endoscopic obliteration with NBC. 20,22 Endoscopic injection of tissue glue for gastric variceal bleeding was first reported in 1986 by Soehendra et al 12 Since then, this method has been adopted widely and proved to be effective in the hemostasis of gastric variceal bleeding. [23][24][25][26][27][28]30 NBC, a liquid monomer, undergoes rapid exothermic polymerization on contact with living tissues, and this property of the compound has been used to eradicate and treat GV.…”

“…The relative efficacy of glue injection in the control of active gastric variceal bleed has been addressed in three randomized trials; it has been compared to sclerotherapy in one trial and variceal ligation in two. 22,24 Two trials demonstrated better control of bleed with the use of glue injection as compared to sclerotherapy or variceal ligation (89% vs. 62% and 87% vs. 45%) 27 ; the third showed equivalent results as variceal ligation. 22 Rebleed was significantly lower with glue injection when compared to variceal ligation (31% vs. 54%) 22,28 and similar to sclerotherapy.…”

“…22,24 Two trials demonstrated better control of bleed with the use of glue injection as compared to sclerotherapy or variceal ligation (89% vs. 62% and 87% vs. 45%) 27 ; the third showed equivalent results as variceal ligation. 22 Rebleed was significantly lower with glue injection when compared to variceal ligation (31% vs. 54%) 22,28 and similar to sclerotherapy. Glue injection achieves variceal eradication in about 75% of patients (range: 50%-100%) with rebleed in 23%-50% of patients.…”

“…In this study, the success rate of acute hemostasis was 98.4%, comparable with other studies. 22,30 Though NBC has been used worldwide for the treatment for gastric varices, data regarding the long-term efficacy and safety of this procedure are still lacking. Indeed, although rare, fatal complications like systemic and pulmonary embolization do occur.…”

“…Indeed, although rare, fatal complications like systemic and pulmonary embolization do occur. 22,28 Such events are especially commoner in those with large gastro-renal shunts and hepatopulmonary syndrome and caution is required with the use of glue in such patients. 8 In our study there were no post glue complications.…”