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

Hepatocellular Carcinoma Clinical Trial

— SOMAPROTECT01  

Official title:

Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma: Multicenter Randomized Double-blind Placebo Controlled Trial (SOMAPROTECT01)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02799212
• Other study ID #: 69HCL16_0129
• Secondary ID: 2016-004230-20
• Status: Completed
• Phase: Phase 3
• Start date: January 10, 2018
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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:

• 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

Related Conditions & MeSH terms

• Ascites
• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• somatostatin infusion
postoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day.
• placebo infusion
Placebo infusion (50ml of 0.9% NaCl/day) during 6 days.

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 90
Secondary	Duration of ascites	Number of days with = 500ml / 24h of ascites	Day 90
Secondary	Volume of ascites	Total ascites volume	Day 90
Secondary	postoperative morbidity	Postoperative morbidity according to Dindo-Clavien	Day 90
Secondary	Postoperative morbidity on Liver failure	Presence and severity of hepatic failure according to International Study Group of Liver Surgery (ISGLS)	Day 90
Secondary	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)	Day 90