Somatostatin versus Sengstaken balloon tamponade for primary haemostasia of bleeding esophageal varices. A randomized pilot study.

In this study we evaluate the efficacy of somatostatin (ST) versus balloon tamponade (BT) in controlling bleeding from esophageal varices. Forty-four consecutive patients with active variceal bleeding were randomly assigned to treatment with a continuous infusion of ST at 250 micrograms/h after an initial bolus of 50 micrograms (group A) or to treatment with BT (group B). Five cases were excluded from the final analysis because of methodological issues. Nineteen patients were allocated to group A and twenty to group B. No differences in age, sex, alcohol intake, severity of bleeding or liver failure were found between the groups. Initial haemostasia within the first 4 h of treatment was obtained in 14 (74%) of the patients receiving ST and in 12 (60%) of those receiving BT. Three patients in group A and two in group B had early rebleeding. Bleeding was controlled over a 24-h period or until elective sclerotherapy could be performed in 11 (58%) and 10 (50%) of the patients, in groups A and B, respectively. One BT-treated patient developed aspiration pneumonia. No complications were observed in patients treated with ST. No significant differences in initial haemostasia, definite control of bleeding or complications were found between the two groups. In this study, somatostatin infusion was found to be as effective as Sengstaken BT in controlling acute variceal bleeding until an elective session of endoscopic sclerotherapy could be performed. However, larger studies are still needed to confirm this theory.

RCT Entities:   Population Interventions Outcomes