Fact CheckerSign in

NCT02799212CompletedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 3 Oct 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
179 (actual)
First submitted
9 Jun 2016
Start date
10 Jan 2018
Primary completion date
30 Apr 2024
Lead sponsor
Hospices Civils de Lyon
NCT number
NCT02799212
EudraCT number
2016-004230-20

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 179
  • From 10 Jan 2018 to the primary completion date, 30 Apr 2024
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with evidence of a healthy liver at biopsy
    • Disease-associated non-inclusion criteria include:
  • 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

Other

  • 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).
  • Another histologic type of hepatic tumor besides HCC
  • Distant extra-hepatic metastases, including peritoneal carcinomatosis

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
APHP - Hôpital Beaujon
Coordinator of this site? Confirm its status
ClichyFranceUnknown status
Chru Lille - Hopital Huriez
Coordinator of this site? Confirm its status
LilleFranceUnknown status
Hospices Civils de Lyon - Hôpital de la Croix Rousse
Coordinator of this site? Confirm its status
LyonFranceUnknown status
APHM Hôpital de la Timone
Coordinator of this site? Confirm its status
MarseilleFranceUnknown status
CHU de Bordeaux Hopital Haut leveque
Coordinator of this site? Confirm its status
PessacFranceUnknown status
CHU Rennes - Hopital Pontchaillou
Coordinator of this site? Confirm its status
RennesFranceUnknown status
CHU de Toulouse - Hopital Rangueil
Coordinator of this site? Confirm its status
ToulouseFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.