Hepatocellular CarcinomaPhase 3SOMAPROTECT01NCT02799212
Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma
A Phase 3 study testing somatostatin infusion in people with Hepatocellular Carcinoma, run by Hospices Civils de Lyon at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- somatostatin infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 179 participants
- Where
- 7 sitesFrance
- Study dates
- 10 Jan 2018to 30 Apr 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- Age ≥ 18 years
- Patients with ability to understand and sign a written inform consent form
- Patients who will be available for follow-up
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
APHP - Hôpital Beaujon
Clichy
CHRU Lille - Hopital Huriez
Lille
Hospices Civils de Lyon - Hôpital de la Croix Rousse
Lyon, 69004
APHM - Hôpital de la Timone
Marseille
CHU de Bordeaux - Hôpital Haut Lévèque
Pessac
CHU Rennes - Hôpital Pontchaillou
Rennes
CHU de Toulouse - Hopital Rangueil
Toulouse
About this study
Official title: Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma: Multicenter Randomized Double-blind Placebo Controlled Trial (SOMAPROTECT01)
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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- somatostatin infusion, placebo infusion
- Keywords
- Hepatocellular carcinoma, Hepatectomy, Ascites, Somatostatin
- Medical subject headings
- Carcinoma, Hepatocellular, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatostatin infusionDrug
postoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day.
placebo infusionDrug
Placebo infusion (50ml of 0.9% NaCl/day) during 6 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | postoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day Receives: Drug: somatostatin infusion |
| Control group | Placebo comparator | Placebo infusion (50ml of 0.9% NaCl/day) during 6 days Receives: Drug: placebo infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 90
Secondary outcomes (5)
Duration of ascites
Number of days with ≥ 500ml / 24h of ascites
Measured: Day 90
Volume of ascites
Total ascites volume
Measured: Day 90
postoperative morbidity
Postoperative morbidity according to Dindo-Clavien
Measured: Day 90
Postoperative morbidity on Liver failure
Presence and severity of hepatic failure according to International Study Group of Liver Surgery (ISGLS)
Measured: 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)
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start10 Jan 2018
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799212
- Sponsor's protocol ID
- 69HCL16_0129
- Other IDs
- 2016-004230-20, 2016
- Acronym
- SOMAPROTECT01
- Status last verified
- Sep 2025
- First submitted
- 9 Jun 2016
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30139340
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma: Multicenter Randomized Double-blind Placebo Controlled Trial (SOMAPROTECT01)
- ClinicalTrials.gov ID
- NCT02799212
- Acronym / sponsor ID
- SOMAPROTECT01 / 69HCL16_0129
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, Hepatectomy, Ascites, Somatostatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: somatostatin infusionpostoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day |
| Control group | Placebo comparator | Drug: placebo infusionPlacebo infusion (50ml of 0.9% NaCl/day) during 6 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| somatostatin infusionpostoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day. | Drug | Experimental group |
| placebo infusionPlacebo infusion (50ml of 0.9% NaCl/day) during 6 days. | Drug | Control group |
Primary outcome
presence of postoperative ascites during the postoperative course
Time frame: Day 90
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
5 secondary outcomes
Duration of ascites
Time frame: Day 90
Volume of ascites
Time frame: Day 90
postoperative morbidity
Time frame: Day 90
Postoperative morbidity on Liver failure
Time frame: Day 90
Postoperative morbidity on Renal failure
Time frame: Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Background: PubMed 30139340Mohkam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing somatostatin infusion in people with Hepatocellular Carcinoma, run by Hospices Civils de Lyon at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of postoperative ascites during the postoperative course (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02799212, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.