A Phase 3 interventional study of somatostatin infusion and placebo infusion in Hepatocellular Carcinoma, sponsored by Hospices Civils de Lyon. Completed at 7 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by Hospices Civils de Lyon · Phase 3, Interventional, and Prevention
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.
3,180 studies on the registry are indexed under Carcinoma, Hepatocellular; 953 are open to participants now.
This study's enrollment of 179 is above the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Disease-associated non-inclusion criteria include:
Operative technique-associated non-inclusion criteria include:
- Indication of coelioscopy with resection of less than 2 liver segments
postoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day
Drug: somatostatin infusion
Placebo infusion (50ml of 0.9% NaCl/day) during 6 days
Drug: placebo infusion
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.
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
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon