BACKGROUND AND STUDY AIMS: Recently, tissue adhesive material has been used to improve the initial control of bleeding from huge esophagogastric varices, and to prevent them from rebleeding, in contrast to the conventional sclerotherapy. The present study assessed the value of the combined use of the tissue adhesive substance: N-butyl-2-cyanoacrylate and ethanolamine oleate 5% for management of bleeding esophagogastric varices. PATIENTS AND METHODS: One hundred and fourteen patients with documented active variceal bleeding at the time of endoscopy were alternatively randomized into two groups. The combined therapy group included 58 patients who underwent injection using both cyanoacrylate for large esophageal and gastric varices and a sclerosant agent for remaining varices. The sclerosis, or control, group included 56 patients, who underwent injection with ethanolamine oleate. RESULTS: This study proved the value of the combined therapy for the initial control of all bleeders (the follow-up period ranged from 12 to 32 months). In the sclerosis group, failure of the initial control of bleeding was reported in two cases (3.6%). Recurrent bleeding occurred in 8.6% in the combined therapy group compared to 25% in the sclerosis group (p < 0.01). Two months of therapy was required to achieve complete eradication of varices in 56.5% and 21.4% in the combined therapy and the sclerosis group, respectively. The mean number of sessions needed until the time of evaluation was 2.4 +/- 1.1 in the combined therapy group versus 5.1 +/- 2.3 sessions in the sclerosis group. The difference showed high statistical significance (p < 0.01). Minor complications occurred less frequently in the combined therapy group. Only one patient in the combined therapy group developed portal pyemia after extension of the tissue adhesive material from the site of injection into the portal vein. This patient died of hepatic failure. The mortality in the combined therapy group was lower than that in the sclerosis group (3.5% and 8.8% respectively, p > 0.05). CONCLUSION: The combined use of tissue adhesive and sclerosant materials seems to be the best plan for rapid eradication of esophagogastric varices within a short time, requiring the lowest number of injection sessions and involving minor complications and low mortality.
RCT Entities:
BACKGROUND AND STUDY AIMS: Recently, tissue adhesive material has been used to improve the initial control of bleeding from huge esophagogastric varices, and to prevent them from rebleeding, in contrast to the conventional sclerotherapy. The present study assessed the value of the combined use of the tissue adhesive substance: N-butyl-2-cyanoacrylate and ethanolamine oleate 5% for management of bleeding esophagogastric varices. PATIENTS AND METHODS: One hundred and fourteen patients with documented active variceal bleeding at the time of endoscopy were alternatively randomized into two groups. The combined therapy group included 58 patients who underwent injection using both cyanoacrylate for large esophageal and gastric varices and a sclerosant agent for remaining varices. The sclerosis, or control, group included 56 patients, who underwent injection with ethanolamine oleate. RESULTS: This study proved the value of the combined therapy for the initial control of all bleeders (the follow-up period ranged from 12 to 32 months). In the sclerosis group, failure of the initial control of bleeding was reported in two cases (3.6%). Recurrent bleeding occurred in 8.6% in the combined therapy group compared to 25% in the sclerosis group (p < 0.01). Two months of therapy was required to achieve complete eradication of varices in 56.5% and 21.4% in the combined therapy and the sclerosis group, respectively. The mean number of sessions needed until the time of evaluation was 2.4 +/- 1.1 in the combined therapy group versus 5.1 +/- 2.3 sessions in the sclerosis group. The difference showed high statistical significance (p < 0.01). Minor complications occurred less frequently in the combined therapy group. Only one patient in the combined therapy group developed portal pyemia after extension of the tissue adhesive material from the site of injection into the portal vein. This patient died of hepatic failure. The mortality in the combined therapy group was lower than that in the sclerosis group (3.5% and 8.8% respectively, p > 0.05). CONCLUSION: The combined use of tissue adhesive and sclerosant materials seems to be the best plan for rapid eradication of esophagogastric varices within a short time, requiring the lowest number of injection sessions and involving minor complications and low mortality.
Authors: Joaquin Poza Cordon; Consuelo Froilan Torres; Aurora Burgos García; Francisco Gea Rodriguez; Jose Manuel Suárez de Parga Journal: World J Gastrointest Endosc Date: 2012-07-16