Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma (SOMAPROTECT01)

March 28, 2024 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Clichy, France
        • APHP - Hôpital Beaujon
      • Lille, France
        • CHRU Lille - Hôpital Huriez
      • Lyon, France, 69004
        • Hospices Civils de Lyon - Hopital de la Croix Rousse
      • Marseille, France
        • APHM - Hopital de la Timone
      • Pessac, France
        • CHU de Bordeaux - Hôpital Haut Leveque
      • Rennes, France
        • CHU Rennes - Hopital Pontchaillou
      • Toulouse, France
        • CHU de Toulouse - Hôpital Rangueil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
postoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day
Drug: somatostatin infusion
postoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day.
Placebo Comparator: Control group
Placebo infusion (50ml of 0.9% NaCl/day) during 6 days
Drug: placebo infusion
Placebo infusion (50ml of 0.9% NaCl/day) during 6 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of ascites
Time Frame: Day 90
Number of days with ≥ 500ml / 24h of ascites
Day 90
Volume of ascites
Time Frame: Day 90
Total ascites volume
Day 90
postoperative morbidity
Time Frame: Day 90
Postoperative morbidity according to Dindo-Clavien
Day 90
Postoperative morbidity on Liver failure
Time Frame: Day 90
Presence and severity of hepatic failure according to International Study Group of Liver Surgery (ISGLS)
Day 90
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)
Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2018

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

June 9, 2016

First Submitted That Met QC Criteria

June 13, 2016

First Posted (Estimated)

June 14, 2016

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL16_0129
  • 2016-004230-20 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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