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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
179
postoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day.
Placebo infusion (50ml of 0.9% NaCl/day) during 6 days.
APHP - Hôpital Beaujon
Clichy, France
CHRU Lille - Hopital Huriez
Lille, France
Hospices Civils de Lyon - Hôpital de la Croix Rousse
Lyon, France
APHM - Hôpital de la Timone
Marseille, France
CHU de Bordeaux - Hôpital Haut Lévèque
Pessac, France
CHU Rennes - Hôpital Pontchaillou
Rennes, France
CHU de Toulouse - Hopital Rangueil
Toulouse, France
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
Time frame: Day 90
Duration of ascites
Number of days with ≥ 500ml / 24h of ascites
Time frame: Day 90
Volume of ascites
Total ascites volume
Time frame: Day 90
postoperative morbidity
Postoperative morbidity according to Dindo-Clavien
Time frame: Day 90
Postoperative morbidity on Liver failure
Presence and severity of hepatic failure according to International Study Group of Liver Surgery (ISGLS)
Time frame: Day 90
Postoperative morbidity on Renal failure
Presence and severity of renal failure according to RIFLE scale (RIFLE: Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease)
Time frame: Day 90
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