BACKGROUND:Patients with hepatocellular carcinoma complicated by variceal bleeding have a very limited life span. Recurrent bleeding after endoscopic injection sclerotherapy is common. Our aim was to compare the efficacy of endoscopic injection of cyanoacrylate versus sodium tetradecyl sulphate in the control of variceal bleeding in patients with hepatocellular carcinoma. METHODS:Patients known to be suffering from inoperable hepatocellular carcinoma who presented with upper gastrointestinal bleeding underwent endoscopy within 24 hours of admission. After bleeding from esophageal varices was confirmed, they were randomized to receive endoscopic injections of either cyanoacrylate (1:1 mixture with Lipoidol) or sodium tetradecyl sulphate (1.5%). Injection were given intravariceally into each visible column for up to four injections for cyanoacrylate and up to 30 mL for sodium tetradecyl sulphate. RESULTS:A total of 50 patients were recruited for this study with 25 cases randomized to each endoscopic treatment group. Control of acute bleeding failed in four patients (16%) in both treatment groups, and two patients in each group died during the index episode of bleeding. Six patients (24%) in the cyanoacrylate group and four patients (16%) in the sodium tetradecyl sulphate group developed recurrent bleeding during their hospital stay (p = 0.48). Recurrent bleeding within 30 days after the index episode of bleeding was documented in seven patients (28%) who received cyanoacrylate injection and five patients (20%) who received sodium tetradecyl sulphate injection (p = 0.51). Median survival in the cyanoacrylate group was 16 days (range 1 to 485 days) and that of the sodium tetradecyl sulphate group was 13 days (range 1 to 407 days). There was no difference in cumulative survival between the two groups as analyzed by the Kaplan-Meier method. Patients with portal vein thrombosis had a higher risk of recurrent hemorrhage. Patients with Child's C liver disease had a significantly higher mortality. CONCLUSIONS:Cyanoacrylate did not improve the outcome of hepatocellular carcinoma patients with variceal hemorrhage.
RCT Entities:
BACKGROUND:Patients with hepatocellular carcinoma complicated by variceal bleeding have a very limited life span. Recurrent bleeding after endoscopic injection sclerotherapy is common. Our aim was to compare the efficacy of endoscopic injection of cyanoacrylate versus sodium tetradecyl sulphate in the control of variceal bleeding in patients with hepatocellular carcinoma. METHODS:Patients known to be suffering from inoperable hepatocellular carcinoma who presented with upper gastrointestinal bleeding underwent endoscopy within 24 hours of admission. After bleeding from esophageal varices was confirmed, they were randomized to receive endoscopic injections of either cyanoacrylate (1:1 mixture with Lipoidol) or sodium tetradecyl sulphate (1.5%). Injection were given intravariceally into each visible column for up to four injections for cyanoacrylate and up to 30 mL for sodium tetradecyl sulphate. RESULTS: A total of 50 patients were recruited for this study with 25 cases randomized to each endoscopic treatment group. Control of acute bleeding failed in four patients (16%) in both treatment groups, and two patients in each group died during the index episode of bleeding. Six patients (24%) in the cyanoacrylate group and four patients (16%) in the sodium tetradecyl sulphate group developed recurrent bleeding during their hospital stay (p = 0.48). Recurrent bleeding within 30 days after the index episode of bleeding was documented in seven patients (28%) who received cyanoacrylate injection and five patients (20%) who received sodium tetradecyl sulphate injection (p = 0.51). Median survival in the cyanoacrylate group was 16 days (range 1 to 485 days) and that of the sodium tetradecyl sulphate group was 13 days (range 1 to 407 days). There was no difference in cumulative survival between the two groups as analyzed by the Kaplan-Meier method. Patients with portal vein thrombosis had a higher risk of recurrent hemorrhage. Patients with Child's C liver disease had a significantly higher mortality. CONCLUSIONS:Cyanoacrylate did not improve the outcome of hepatocellular carcinomapatients with variceal hemorrhage.