Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma

What Was Tested

The trial (phase 3) is built around Somatostatin.

Most patients undergoing hepatectomy for hepatocellular carcinoma (HCC) suffer from underlying liver disease and are exposed to the risk of postoperative ascites, with subsequent morbidity, liver and renal failure, the need for specific treatments and prolonged hospital stay.

Postoperative ascites is favored by an imbalance between portal venous inflow and the diminished hepatic venous outflow.

It had two arms (groups): Experimental group (experimental) and Control group (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 179 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients with HCC diagnosed by histology or by imaging findings according to the Barcelona Clinic Liver Cancer Group. Patients with a single or multiple HCCs deemed to be resectable with a curative intent at the preoperative evaluation. Patients for whom an indication for hepatectomy has been decided and approved by multidisciplinary board:. By coelioscopy with resection of at least 2 liver segments. Age ≥ 18 years.

The full record lists 9 inclusion and 5 exclusion criteria; among the exclusions: patients with evidence of a healthy liver at biopsy; another histologic type of hepatic tumor besides hcc; distant extra-hepatic metastases, including peritoneal carcinomatosis.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Somatostatin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Somatostatin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2018-01-10 with completion listed for 2024-04-30.

It ran at 7 sites in France (7).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: presence of postoperative ascites during the postoperative course (time frame: Day 90).

It also tracked 5 secondary outcomes, for example Duration of ascites, Volume of ascites, postoperative morbidity, Postoperative morbidity on Liver failure and Postoperative morbidity on Renal failure.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Somatostatin in 179 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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