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

Civil Hospices of Lyon

Status and phase: Completed; Phase 3

Conditions: Hepatocellular Carcinoma

Treatments: Drug: placebo infusion; Drug: somatostatin infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT02799212

69HCL16_0129

2016-004230-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 179 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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179 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

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

Treatment:

Drug: somatostatin infusion

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo infusion