Evaluation of postoperative ascites after somatostatin infusion following hepatectomy for hepatocellular carcinoma by laparotomy: a multicenter randomized double-blind controlled trial (SOMAPROTECT)

What Was Tested

This randomized controlled trial paper looks at Somatostatin.

The researchers aimed to evaluate the impact of somatostatin postoperative infusion on the incidence of ascites following hepatectomy by laparotomy for HCC in patients with underlying liver disease.

Why It Was Studied

The majority of patients undergoing hepatectomy for hepatocellular carcinoma (HCC) suffer from underlying liver disease and are exposed to the risk of postoperative ascites, which is favored by an imbalance between portal venous inflow and a diminished hepatic volume.

Finding a reversible, non-invasive method for modulating the portal inflow would be of interest as it could be used temporarily during the early postoperative course.

Who Took Part

PubMed indexes the participants as adults, middle-aged adults and older adults, both men and women.

The SOMAPROTECT study is a multicenter randomized double-blind placebo controlled phase III trial comparing two arms of patients with underlying liver disease undergoing hepatectomy for HCC by open approach.

All patients will have primary abdominal drainage before closure.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and multicenter study.

The participants were allocated by chance, so the Somatostatin group and the comparison group should start out alike.

As a double-blind Somatostatin study, the assignments were hidden from both participants and investigators until the end.

Some participants received a placebo instead of Somatostatin, giving a reference point.

Running at several centres spread the Somatostatin study over different clinics and patient groups.

The methods mention a period of 6 days.

Patients in the experimental arm will receive a postoperative intravenous infusion of somatostatin during 6 days.

Patients in the control group will receive a placebo infusion for the same duration.

Secondary endpoints will be duration and total volume of ascites, postoperative 90-day mortality and morbidity, liver failure, acute renal failure, length of stay in intensive care unit and hospital stay.

The total number of patients to be enrolled was calculated to be 152.

What Was Measured

PubMed files the paper under topics including Ascites, Carcinoma, Hepatocellular, Hepatectomy, Laparotomy, Liver Neoplasms, Portal Vein and Postoperative Period.

The authors tagged it with the keywords Andomized controlled trial, Hepatocellular carcinoma, Omatostatin and Surgery.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Somatostatin over 6 days.

Results are reported in around 2 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2018 (BMC cancer), a journal based in England.

More context: the Somatostatin compound page, all human trials.