Endoscopic sclerosis versus cyanoacrylate endoscopic injection for the first episode of variceal bleeding: a prospective, controlled, and randomized study in Child-Pugh class C patients.

BACKGROUND AND STUDY AIMS: Despite the recognized efficacy of sclerotherapy and elastic band ligation in controlling variceal hemorrhage, the results of endoscopic treatment in Child-Pugh class C patients remain poor. The aim of this prospective, controlled, and randomized study was to compare conventional sclerotherapy with injection of the tissue adhesive N-butyl-2-cyanoacrylate in controlling the first episode of rupturing of esophageal varices. PATIENTS AND METHODS: From January 1994 to June 1997, 36 consecutive Child-Pugh class C cirrhotic patients were admitted with an initial episode of esophageal variceal bleeding. They were randomly assigned to receive sclerotherapy with a 3% ethanolamine oleate solution (group 1, 18 patients) or injection of tissue adhesive (group 2, 18 patients). Episodes of recurrent bleeding were managed after the randomization procedure. After bleeding had been controlled, patients in both groups received weekly sessions of conventional sclerotherapy to eradicate any remaining esophageal veins.
RESULTS: The patients in the two treatment groups had similar characteristics on entry into the study. More than 80% of the patients were admitted with moderate or severe hemorrhage. Approximately half of them presented with active bleeding during the index endoscopy. Early recurrent bleeding was observed in ten of the 18 patients in group 1 (55.6%) and in two of the 18 in group 2 (11.1%; P = 0.01). The hospital mortality rates were 72.2% in group I and 33.3% in group II (P = 0.04).
CONCLUSION: These findings support the view that cyanoacrylate injection is superior to conventional sclerosis for controlling esophageal variceal bleeding in Child-Pugh class C patients. It is also highly probable that the better bleeding control achieved using the cyanoacrylate tissue adhesive treatment led to a lower hospital mortality rate.

RCT Entities:   Population Interventions Outcomes