Primary Liver CancersNCT02145013
Portal Hypertension and Liver Resection in Patients With Hepatocellular Carcinoma
An observational study of Primary Liver Cancers, run by Henri Mondor University Hospital at 1 site in France.
Trial summary
According to the BCLC guidelines, surgical resection of hepatocellular carcinoma complicating cirrhosis is restricted to patients with preserved liver function, single nodule without vascular invasion and with hepatic venous gradient below 10 mmHg. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Liver Cancers
- What is being tested?
- Liver resection
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to 30 May 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with hepatocellular carcinoma
Patients with hepatocellular carcinoma who undergo surgical resection (intention to treat analysis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment and Impact of Portal Hypertension Before and During Liver Resection in Patients With Hepatocellular Carcinoma
According to the BCLC guidelines, surgical resection of hepatocellular carcinoma complicating cirrhosis is restricted to patients with preserved liver function, single nodule without vascular invasion and with hepatic venous gradient below 10 mmHg.
However, other guideline treatment, especially from eastern countries demonstrated that surgical resection is safe and feasible and provides better survival than the treatment recommended by the BCLC system for patients with similar stage.
The primary goal of this study is to assess the impact of HVPG on short and long-term outcomes in HCC patients who undergo liver resection.
Read the detailed description
Patients with HCC and candidates for hepatectomy are classified into two groups according to the presence of portal hypertension. Short- and long-term outcomes will be compared.
- Conditions
- Primary Liver Cancers
- Being tested
- Liver resection
- Keywords
- portal hypertension, hepatocellular carcinoma, resection
- Medical subject headings
- Hypertension, Portal, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver resectionProcedure or surgery
Hepatectomy by either open, laparoscopic or robotic procedures
| Study group | Role | What they receive |
|---|---|---|
| Portal hypertension | Hepatectomy Receives: Procedure: Liver resection | |
| No portal hypertension | Hepatectomy Receives: Procedure: Liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
In-hospital or 90-day mortality
Measured: 90 day
Secondary outcomes (2)
morbidity
Overall and liver-related complications including liver failure, ascites, biliary fistula, bleeding, pulmonary complications, and renal complications.
Grading system according to Clavien-Dindo classification
Measured: 90 day
Survival outcomes
Including Overall survival and disease free survival
Measured: 1,3 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2017
- Study completion30 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Primary Liver CancersStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henri Mondor University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chetana LIM, Henri Mondor University Hospital
- Investigators
- Daniel Azoulay, MD PhD, Principal investigator, Henri Mondor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145013
- Sponsor's protocol ID
- LIM Chetana
- Status last verified
- Feb 2018
- First submitted
- 20 May 2014
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Ishizawa T, Hasegawa K, Aoki T, Takahashi M, Inoue Y, Sano K, Imamura H, Sugawara Y, Kokudo N, Makuuchi M. Neither multiple tumors nor portal hypertension are surgical contraindications for hepatocellular carcinoma. Gastroenterology. 2008 Jun;134(7):1908-16. doi: 10.1053/j.gastro.2008.02.091. Epub 2008 Mar 8.
PubMed 18549877Lim C, Salloum C, Chalaye J, Lahat E, Costentin CE, Osseis M, Itti E, Feray C, Azoulay D. 18F-FDG PET/CT predicts microvascular invasion and early recurrence after liver resection for hepatocellular carcinoma: A prospective observational study. HPB (Oxford). 2019 Jun;21(6):739-747. doi: 10.1016/j.hpb.2018.10.007. Epub 2018 Nov 3.
PubMed 30401520Lim C, Osseis M, Lahat E, Doussot A, Sotirov D, Hemery F, Lanteri-Minet M, Feray C, Salloum C, Azoulay D. Safety of laparoscopic hepatectomy in patients with hepatocellular carcinoma and portal hypertension: interim analysis of an open prospective study. Surg Endosc. 2019 Mar;33(3):811-820. doi: 10.1007/s00464-018-6347-1. Epub 2018 Jul 12.
PubMed 30003350Lim C, Salloum C, Osseis M, Lahat E, Gomez-Gavara C, Compagnon P, Luciani A, Feray C, Azoulay D. Short-term outcomes following hepatectomy for hepatocellular carcinoma within and beyond the BCLC guidelines: A prospective study. HPB (Oxford). 2018 Mar;20(3):222-230. doi: 10.1016/j.hpb.2017.08.027. Epub 2017 Sep 19.
PubMed 28935451
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Impact of Portal Hypertension Before and During Liver Resection in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02145013
- Acronym / sponsor ID
- LIM Chetana
- Conditions
- Primary Liver Cancers
- Keywords
- portal hypertension, hepatocellular carcinoma, resection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Henri Mondor University HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- 30 May 2018 (estimated)
- First posted
- 22 May 2014 (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.
According to the BCLC guidelines, surgical resection of hepatocellular carcinoma complicating cirrhosis is restricted to patients with preserved liver function, single nodule without vascular invasion and with hepatic venous gradient below 10 mmHg.
However, other guideline treatment, especially from eastern countries demonstrated that surgical resection is safe and feasible and provides better survival than the treatment recommended by the BCLC system for patients with similar stage.
The primary goal of this study is to assess the impact of HVPG on short and long-term outcomes in HCC patients who undergo liver resection.
Detailed description
Patients with HCC and candidates for hepatectomy are classified into two groups according to the presence of portal hypertension. Short- and long-term outcomes will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Portal hypertension | – | Procedure: Liver resectionHepatectomy |
| No portal hypertension | – | Procedure: Liver resectionHepatectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with hepatocellular carcinoma
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 |
|---|---|---|
| Liver resectionHepatectomy by either open, laparoscopic or robotic procedures | Procedure or surgery | No portal hypertension, Portal hypertension |
Primary outcome
Mortality
Time frame: 90 day
In-hospital or 90-day mortality
2 secondary outcomes
morbidity
Time frame: 90 day
Survival outcomes
Time frame: 1,3 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2018.
- Background: PubMed 18549877Ishizawa T, Hasegawa K, Aoki T, Takahashi M, Inoue Y, Sano K, Imamura H, Sugawara Y, Kokudo N, Makuuchi M. Neither multiple tumors nor portal hypertension are surgical contraindications for hepatocellular carcinoma. Gastroenterology. 2008 Jun;134(7):1908-16. doi: 10.1053/j.gastro.2008.02.091. Epub 2008 Mar 8.
- Derived from this study: PubMed 30401520Lim C, Salloum C, Chalaye J, Lahat E, Costentin CE, Osseis M, Itti E, Feray C, Azoulay D. 18F-FDG PET/CT predicts microvascular invasion and early recurrence after liver resection for hepatocellular carcinoma: A prospective observational study. HPB (Oxford). 2019 Jun;21(6):739-747. doi: 10.1016/j.hpb.2018.10.007. Epub 2018 Nov 3.
- Derived from this study: PubMed 30003350Lim C, Osseis M, Lahat E, Doussot A, Sotirov D, Hemery F, Lanteri-Minet M, Feray C, Salloum C, Azoulay D. Safety of laparoscopic hepatectomy in patients with hepatocellular carcinoma and portal hypertension: interim analysis of an open prospective study. Surg Endosc. 2019 Mar;33(3):811-820. doi: 10.1007/s00464-018-6347-1. Epub 2018 Jul 12.
- Derived from this study: PubMed 28935451Lim C, Salloum C, Osseis M, Lahat E, Gomez-Gavara C, Compagnon P, Luciani A, Feray C, Azoulay D. Short-term outcomes following hepatectomy for hepatocellular carcinoma within and beyond the BCLC guidelines: A prospective study. HPB (Oxford). 2018 Mar;20(3):222-230. doi: 10.1016/j.hpb.2017.08.027. Epub 2017 Sep 19.
- Individual participant dataSharing planned: Undecided
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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.
Daniel Azoulay, MD PhD principal investigator
Henri Mondor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Liver Cancers, run by Henri Mondor University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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?
Mortality (time frame: 90 day). 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 NCT02145013, which also lists 4 linked publications.
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 12 Feb 2018.