somatostatin infusion
Drugpostoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day.
NCT Number: NCT02799212
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
APHP - Hôpital Beaujon, Clichy, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Disease-associated non-inclusion criteria include:
Operative technique-associated non-inclusion criteria include:
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.
Time frame: Day 90
The presence of postoperative ascites during the postoperative course defined by:
Time frame: Day 90
Number of days with ≥ 500ml / 24h of ascites
Time frame: Day 90
Total ascites volume
Time frame: Day 90
Postoperative morbidity according to Dindo-Clavien
Time frame: Day 90
Presence and severity of hepatic failure according to International Study Group of Liver Surgery (ISGLS)
Time frame: 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)
Hospices Civils de Lyon
Other
Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma: Multicenter Randomized Double-blind Placebo Controlled Trial (SOMAPROTECT01)
Acronym: SOMAPROTECT01
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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