Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma (SOMAPROTECT01)
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
somatostatin infusion
placebo infusion
Sponsored by
About this trial
This is an interventional prevention trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, Hepatectomy, Ascites, Somatostatin
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
Sites / Locations
- APHP - Hôpital BeaujonRecruiting
- CHRU Lille - Hopital HuriezRecruiting
- Hospices Civils de Lyon - Hôpital de la Croix RousseRecruiting
- APHM - Hôpital de la Timone
- CHU de Bordeaux - Hôpital Haut Lévèque
- CHU Rennes - Hôpital PontchaillouRecruiting
- CHU de Toulouse - Hopital RangueilRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Control group
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Duration of ascites
Number of days with ≥ 500ml / 24h of ascites
Volume of ascites
Total ascites volume
postoperative morbidity
Postoperative morbidity according to Dindo-Clavien
Postoperative morbidity on Liver failure
Presence and severity of hepatic failure according to International Study Group of Liver Surgery (ISGLS)
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)
Full Information
NCT ID
NCT02799212
First Posted
June 9, 2016
Last Updated
February 27, 2023
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT02799212
Brief Title
Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma
Acronym
SOMAPROTECT01
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
April 25, 2024 (Anticipated)
Study Completion Date
April 25, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular carcinoma, Hepatectomy, Ascites, Somatostatin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
177 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
postoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Placebo infusion (50ml of 0.9% NaCl/day) during 6 days
Intervention Type
Drug
Intervention Name(s)
somatostatin infusion
Intervention Description
postoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day.
Intervention Type
Drug
Intervention Name(s)
placebo infusion
Intervention Description
Placebo infusion (50ml of 0.9% NaCl/day) during 6 days.
Primary Outcome Measure Information:
Title
presence of postoperative ascites during the postoperative course
Description
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
Secondary Outcome Measure Information:
Title
Duration of ascites
Description
Number of days with ≥ 500ml / 24h of ascites
Time Frame
Day 90
Title
Volume of ascites
Description
Total ascites volume
Time Frame
Day 90
Title
postoperative morbidity
Description
Postoperative morbidity according to Dindo-Clavien
Time Frame
Day 90
Title
Postoperative morbidity on Liver failure
Description
Presence and severity of hepatic failure according to International Study Group of Liver Surgery (ISGLS)
Time Frame
Day 90
Title
Postoperative morbidity on Renal failure
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kayvan Mohkam
Phone
+4 72 07 11 00
Email
kayvan.mohkam@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Solène Pantel
Phone
+33 4 26 73 27 25
Email
solene.pantel02@chu-lyon.fr
Facility Information:
Facility Name
APHP - Hôpital Beaujon
City
Clichy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mickael LESURTEL
Email
Mickael.Lesurtel@aphp.fr
First Name & Middle Initial & Last Name & Degree
Mickael LESURTEL
First Name & Middle Initial & Last Name & Degree
Linda KHOY-EAR
Facility Name
CHRU Lille - Hopital Huriez
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie TRUANT
Email
stephanie.truant@chru-lille.fr
First Name & Middle Initial & Last Name & Degree
Stéphanie TRUANT
First Name & Middle Initial & Last Name & Degree
Gilles LEBUFFE
Facility Name
Hospices Civils de Lyon - Hôpital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kayvan Mohkam
Phone
+33 4 72 07 11 00
Email
Kayvan.mohkam@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Solène Pantel
Phone
+33 4 26 73 27 25
Email
solene.pantel@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Kayvan Mohkam
Facility Name
APHM - Hôpital de la Timone
City
Marseille
Country
France
Individual Site Status
Completed
Facility Name
CHU de Bordeaux - Hôpital Haut Lévèque
City
Pessac
Country
France
Individual Site Status
Completed
Facility Name
CHU Rennes - Hôpital Pontchaillou
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim BOUDJEMA
Email
karim.boudjema@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Karim BOUDJEMA
First Name & Middle Initial & Last Name & Degree
Hélène BELOEIL
Facility Name
CHU de Toulouse - Hopital Rangueil
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice MUSCARI
Email
muscari.f@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Fabrice MUSCARI
First Name & Middle Initial & Last Name & Degree
Pierre ROBERT
12. IPD Sharing Statement
Citations:
PubMed Identifier
30139340
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.
Results Reference
derived
Learn more about this trial
Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma
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