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

NCT02799212 | Completed Phase 3

• 2 other identifiers: 69HCL16_01292016-004230-20
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; Hepatectomy; Ascites; Somatostatin

Outcome Measures

Primary Outcomes (1)

• presence of postoperative ascites during the postoperative course

  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 Outcomes (5)

• Duration of ascites

  Day 90

• Volume of ascites

  Day 90

• postoperative morbidity

  Day 90

• Postoperative morbidity on Liver failure

  Day 90

• Postoperative morbidity on Renal failure

  Day 90

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Drug: somatostatin infusion

Control group

PLACEBO COMPARATOR

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

Drug: placebo infusion

Interventions

somatostatin infusion DRUG

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

Experimental group

placebo infusion DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with evidence of a healthy liver at biopsy
• 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
• \- Indication of coelioscopy with resection of less than 2 liver segments

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (7)

APHP - Hôpital Beaujon

Clichy, France

Location

CHRU Lille - Hopital Huriez

Lille, France

Location

Hospices Civils de Lyon - Hôpital de la Croix Rousse

Lyon, 69004, France

Location

APHM - Hôpital de la Timone

Marseille, France

Location

CHU de Bordeaux - Hôpital Haut Lévèque

Pessac, France

Location

CHU Rennes - Hôpital Pontchaillou

Rennes, France

Location

CHU de Toulouse - Hopital Rangueil

Toulouse, France

Location

Related Publications (1)

• Mohkam K, Rayar M, Adam JP, Muscari F, Rode A, Merle P, Pradat P, Bauler S, Delfour I, Chiche L, Ducerf C, Boudjema K, Lesurtel M, Laurent C, Mabrut JY. Evaluation of postoperative ascites after somatostatin infusion following hepatectomy for hepatocellular carcinoma by laparotomy: a multicenter randomized double-blind controlled trial (SOMAPROTECT). BMC Cancer. 2018 Aug 23;18(1):844. doi: 10.1186/s12885-018-4667-0.

  PMID: 30139340 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Ascites

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 14, 2016
• Study Start: January 10, 2018
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

FR (7)