Clinical trial NCT02799212: Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma
Official title: Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma: Multicenter Randomized Double-blind Placebo Controlled Trial (SOMAPROTECT01)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
Hepatectomy
Ascites
Somatostatin
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-06-14
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: presence of postoperative ascites during the postoperative course
timeFrame: Day 90
Secondary outcomes:
measure: Duration of ascites
timeFrame: Day 90
measure: Volume of ascites
timeFrame: Day 90
measure: postoperative morbidity
timeFrame: Day 90
measure: Postoperative morbidity on Liver failure
timeFrame: Day 90
measure: Postoperative morbidity on Renal failure
timeFrame: Day 90
Other outcomes:
Locations:
city: Clichy
country: France
facility: APHP - Hôpital Beaujon
city: Lille
country: France
facility: CHRU Lille - Hopital Huriez
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hôpital de la Croix Rousse
city: Marseille
country: France
facility: APHM - Hôpital de la Timone
city: Pessac
country: France
facility: CHU de Bordeaux - Hôpital Haut Lévèque
city: Rennes
country: France
facility: CHU Rennes - Hôpital Pontchaillou
city: Toulouse
country: France
facility: CHU de Toulouse - Hopital Rangueil
Study officials:
References:
citation: Mohkam K, Rayar M, Adam JP, Muscari F, Rode A, Merle P, Pradat P, Bauler S, Delfour I, Chiche L, Ducerf C, Boudjema K, Lesurtel M, Laurent C, Mabrut JY. Evaluation of postoperative ascites after somatostatin infusion following hepatectomy for hepatocellular carcinoma by laparotomy: a multicenter randomized double-blind controlled trial (SOMAPROTECT). BMC Cancer. 2018 Aug 23;18(1):844. doi: 10.1186/s12885-018-4667-0.