Skip to main content
OpenTrials
Completed

NCT Number: NCT02799212

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

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. Finding a reversible, non-invasive method for modulating the portal inflow would be of interest: it could be used temporarily during the early postoperative course to prevent acute portal hypertension. Somatostatin, a well-known drug already used in several indications, may limit the risk of postoperative ascites and liver failure by decreasing portal pressure after hepatectomy for HCC in patients with underlying liver disease.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

APHP - Hôpital Beaujon, Clichy, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 laparotomy
  • by coelioscopy with resection of at least 2 liver segments
  • Patients with any underlying liver disease with or without proven cirrhosis, regarding histological features (including F2-F3-F4 fibrosis with or without cirrhosis) or with other evidence of a diseased liver if no biopsy has been performed preoperatively (dysmorphic liver or evidence of portal hypertension at imaging findings, oesophageal varices at endoscopy)
  • Age ≥ 18 years
  • Patients with ability to understand and sign a written inform consent form
  • Patients who will be available for follow-up

Exclusion criteria

  • Patients participating in another interventional research in progress or including an exclusion period still in progress at pre-inclusion (except interventional research with minimal risks and constraints that do not interfere with the judgement criteria of the study according to the judgement of the coordinating investigator).
  • Patients with evidence of a healthy liver at biopsy

Disease-associated non-inclusion criteria include:

  • Another histologic type of hepatic tumor besides HCC
  • Distant extra-hepatic metastases, including peritoneal carcinomatosis
  • The existence of complete portal thrombosis of the main portal trunk

Operative technique-associated non-inclusion criteria include:

  • Indication of coelioscopy with resection of less than 2 liver segments

Treatment and study plan

somatostatin infusion

Drug

postoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day.

placebo infusion

Drug

Placebo infusion (50ml of 0.9% NaCl/day) during 6 days.

Primary outcomes

  1. presence of postoperative ascites during the postoperative course

    Time frame: Day 90

    The presence of postoperative ascites during the postoperative course defined by:

    • ≥500 ml / 24h of fluid in the drains during at least 3 days. Or
    • ascites requiring puncture or drainage

Secondary outcomes

  1. Duration of ascites

    Time frame: Day 90

    Number of days with ≥ 500ml / 24h of ascites

  2. Volume of ascites

    Time frame: Day 90

    Total ascites volume

  3. postoperative morbidity

    Time frame: Day 90

    Postoperative morbidity according to Dindo-Clavien

  4. Postoperative morbidity on Liver failure

    Time frame: Day 90

    Presence and severity of hepatic failure according to International Study Group of Liver Surgery (ISGLS)

  5. Postoperative morbidity on Renal failure

    Time frame: Day 90

    Presence and severity of renal failure according to RIFLE scale (RIFLE: Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma: Multicenter Randomized Double-blind Placebo Controlled Trial (SOMAPROTECT01)

Acronym: SOMAPROTECT01

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jun 14, 2016
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.