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

Phase 3

Completed

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.

Recruitment & Eligibility

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:

Operative technique-associated non-inclusion criteria include:

Arm && Interventions

Group	Intervention	Description
Control group	placebo infusion	Placebo infusion (50ml of 0.9% NaCl/day) during 6 days
Experimental group	somatostatin infusion	postoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day

Primary Outcome Measures

Name	Time	Method
presence of postoperative ascites during the postoperative course	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 Outcome Measures

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

Locations (7): APHP - Hôpital Beaujon
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Clichy, France
CHRU Lille - Hopital Huriez
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Lille, France
Hospices Civils de Lyon - Hôpital de la Croix Rousse
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Lyon, France
APHM - Hôpital de la Timone
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Marseille, France
CHU de Toulouse - Hopital Rangueil
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Toulouse, France
CHU de Bordeaux - Hôpital Haut Lévèque
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Pessac, France
CHU Rennes - Hôpital Pontchaillou
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Rennes, France