Carcinoma, HepatocellularNCT00827723
Indocyanine Green and Portal Pressure in Viral and Alcoholic Cirrhotic Patients With Hepatocarcinoma
An observational study of Carcinoma, Hepatocellular and Alcoholic Cirrhosis, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
The aim of the investigators' study is to elucidate the relationship between a functional liver test (e.g., ICG) and the PREOPERATIVE value of portal hypertension in the patients with impaired liver function from alcoholic and non-alcoholic aetiologies. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Hepatocellular, Alcoholic Cirrhosis, Viral Cirrhosis
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2009to Nov 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: Community sample
Who may be able to join
- resectable or amenable to resection HCC in cirrhotic child A patients of alcoholic or viral etiology
Who cannot join
- cirrhosis Child-Pugh B
- absence of patient consent
- psychiatric pathology
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1005
About this study
Official title: Makuuchi Versus Barcelona Clinic of Liver Cancer Criteria in Cirrhotic Patients With Hepatocellular Carcinoma. Does Etiology of Cirrhosis Influence the Relationship Between the Portal Pressure and Quantitative Tests of Liver Function?
The aim of the investigators' study is to elucidate the relationship between a functional liver test (e.g., ICG) and the PREOPERATIVE value of portal hypertension in the patients with impaired liver function from alcoholic and non-alcoholic aetiologies. Alcoholic and viral cirrhosis present important differences in terms of cellular mechanisms responsible for the disease progression with a distinct and unique gene expression pattern that regulates the type of inflammatory response. These differences probably influence the hepatic functional reserve and the onset of portal hypertension at a comparable clinical and biological level of derangement and the investigators may expect significant differences in the recovery from hepatectomy.
The investigators' hypothesis is that at a comparable ICGR-15 rate non-viral cirrhotic liver presents higher portal pressure values and the investigators also argue that alcoholic cirrhotic patients would tolerate a larger hepatic resection than would viral cirrhotic do.
- Conditions
- Carcinoma, Hepatocellular, Alcoholic Cirrhosis, Viral Cirrhosis, Postoperative Hepatic Failure
- Keywords
- Hepatic functional reserve, Hepatocellular carcinoma (HCC), Indocyanine Green retention rate at 15 minutes (ICG-R15'), Portal Pressure (PP), Hepatic Portal Venous Gradient (HPVG), Alcoholic and Viral Cirrhosis, Makuuchi criteria, Barcelona Clinic of Liver Cancer (BCLC), Hepatic resection
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Cirrhosis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alcoholic | Alcoholic cirrhotic patient with resectable hepatocellular carcinoma | |
| Viral | Viral cirrhotic patient with resectable hepatocellular carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
concordance rate between ICGR-15 and Portal Pressure values in patients with resectable HCC and cirrhosis Child A from alcoholic and non-alcoholic origin.
Measured: 1 year
Secondary outcomes (1)
postoperative liver failure.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas DEMARTINES, University of Lausanne Hospitals
- Investigators
- Diana Michele, MD, Principal investigator, CHUV University Hospital of LausanneHalkic Nermin, PD, Study director, CHUV University Hospital of LausanneDemartines Nicolas, Professeur, Study chair, CHUV University Hospitals of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827723
- Sponsor's protocol ID
- 251/08
- Status last verified
- Nov 2018
- First submitted
- 22 Jan 2009
- Last updated
- 13 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yamazaki S, Takayama T. Surgical treatment of hepatocellular carcinoma: evidence-based outcomes. World J Gastroenterol. 2008 Feb 7;14(5):685-92. doi: 10.3748/wjg.14.685.
PubMed 18205256Imamura H, Seyama Y, Kokudo N, Maema A, Sugawara Y, Sano K, Takayama T, Makuuchi M. One thousand fifty-six hepatectomies without mortality in 8 years. Arch Surg. 2003 Nov;138(11):1198-206; discussion 1206. doi: 10.1001/archsurg.138.11.1198.
PubMed 14609867Torzilli G, Makuuchi M, Inoue K, Takayama T, Sakamoto Y, Sugawara Y, Kubota K, Zucchi A. No-mortality liver resection for hepatocellular carcinoma in cirrhotic and noncirrhotic patients: is there a way? A prospective analysis of our approach. Arch Surg. 1999 Sep;134(9):984-92. doi: 10.1001/archsurg.134.9.984.
PubMed 10487594Llovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet. 2003 Dec 6;362(9399):1907-17. doi: 10.1016/S0140-6736(03)14964-1.
PubMed 14667750Bruix J, Castells A, Bosch J, Feu F, Fuster J, Garcia-Pagan JC, Visa J, Bru C, Rodes J. Surgical resection of hepatocellular carcinoma in cirrhotic patients: prognostic value of preoperative portal pressure. Gastroenterology. 1996 Oct;111(4):1018-22. doi: 10.1016/s0016-5085(96)70070-7.
PubMed 8831597Kobayashi K, Uldry E, Kokudo T, Cristaudi A, Kawaguchi Y, Shirata C, Yamaguchi T, Dormond O, Duran R, Hasegawa K, Demartines N, Halkic N. Correlation Between Portal Pressure and Indocyanine Green Retention Rate is Unaffected by the Cause of Cirrhosis: A Prospective Study. World J Surg. 2021 Aug;45(8):2546-2555. doi: 10.1007/s00268-021-06111-6. Epub 2021 Apr 23.
PubMed 33891139
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Makuuchi Versus Barcelona Clinic of Liver Cancer Criteria in Cirrhotic Patients With Hepatocellular Carcinoma. Does Etiology of Cirrhosis Influence the Relationship Between the Portal Pressure and Quantitative Tests of Liver Function?
- ClinicalTrials.gov ID
- NCT00827723
- Acronym / sponsor ID
- 251/08
- Conditions
- Carcinoma, Hepatocellular, Alcoholic Cirrhosis, Viral Cirrhosis, Postoperative Hepatic Failure
- Keywords
- Hepatic functional reserve, Hepatocellular carcinoma (HCC), Indocyanine Green retention rate at 15 minutes (ICG-R15'), Portal Pressure (PP), Hepatic Portal Venous Gradient (HPVG), Alcoholic and Viral Cirrhosis, Makuuchi criteria, Barcelona Clinic of Liver Cancer (BCLC)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Feb 2009 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 23 Jan 2009 (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.
The aim of the investigators' study is to elucidate the relationship between a functional liver test (e.g., ICG) and the PREOPERATIVE value of portal hypertension in the patients with impaired liver function from alcoholic and non-alcoholic aetiologies. Alcoholic and viral cirrhosis present important differences in terms of cellular mechanisms responsible for the disease progression with a distinct and unique gene expression pattern that regulates the type of inflammatory response. These differences probably influence the hepatic functional reserve and the onset of portal hypertension at a comparable clinical and biological level of derangement and the investigators may expect significant differences in the recovery from hepatectomy.
The investigators' hypothesis is that at a comparable ICGR-15 rate non-viral cirrhotic liver presents higher portal pressure values and the investigators also argue that alcoholic cirrhotic patients would tolerate a larger hepatic resection than would viral cirrhotic do.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcoholic | – | –Alcoholic cirrhotic patient with resectable hepatocellular carcinoma |
| Viral | – | –Viral cirrhotic patient with resectable hepatocellular carcinoma |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (1 listed)
- resectable or amenable to resection HCC in cirrhotic child A patients of alcoholic or viral etiology
Key exclusion criteria (3 listed)
- cirrhosis Child-Pugh B
- absence of patient consent
- psychiatric pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
concordance rate between ICGR-15 and Portal Pressure values in patients with resectable HCC and cirrhosis Child A from alcoholic and non-alcoholic origin.
Time frame: 1 year
1 secondary outcome
postoperative liver failure.
Time frame: 1 year
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 13 Nov 2018.
- Background: PubMed 18205256Yamazaki S, Takayama T. Surgical treatment of hepatocellular carcinoma: evidence-based outcomes. World J Gastroenterol. 2008 Feb 7;14(5):685-92. doi: 10.3748/wjg.14.685.
- Background: PubMed 14609867Imamura H, Seyama Y, Kokudo N, Maema A, Sugawara Y, Sano K, Takayama T, Makuuchi M. One thousand fifty-six hepatectomies without mortality in 8 years. Arch Surg. 2003 Nov;138(11):1198-206; discussion 1206. doi: 10.1001/archsurg.138.11.1198.
- Background: PubMed 10487594Torzilli G, Makuuchi M, Inoue K, Takayama T, Sakamoto Y, Sugawara Y, Kubota K, Zucchi A. No-mortality liver resection for hepatocellular carcinoma in cirrhotic and noncirrhotic patients: is there a way? A prospective analysis of our approach. Arch Surg. 1999 Sep;134(9):984-92. doi: 10.1001/archsurg.134.9.984.
- Background: PubMed 14667750Llovet JM, Burroughs A, Bruix J. Hepatocellular carcinoma. Lancet. 2003 Dec 6;362(9399):1907-17. doi: 10.1016/S0140-6736(03)14964-1.
- Background: PubMed 8831597Bruix J, Castells A, Bosch J, Feu F, Fuster J, Garcia-Pagan JC, Visa J, Bru C, Rodes J. Surgical resection of hepatocellular carcinoma in cirrhotic patients: prognostic value of preoperative portal pressure. Gastroenterology. 1996 Oct;111(4):1018-22. doi: 10.1016/s0016-5085(96)70070-7.
- Derived from this study: PubMed 33891139Kobayashi K, Uldry E, Kokudo T, Cristaudi A, Kawaguchi Y, Shirata C, Yamaguchi T, Dormond O, Duran R, Hasegawa K, Demartines N, Halkic N. Correlation Between Portal Pressure and Indocyanine Green Retention Rate is Unaffected by the Cause of Cirrhosis: A Prospective Study. World J Surg. 2021 Aug;45(8):2546-2555. doi: 10.1007/s00268-021-06111-6. Epub 2021 Apr 23.
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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.
Diana Michele, MD principal investigator
CHUV University Hospital of Lausanne
Halkic Nermin, PD study director
CHUV University Hospital of Lausanne
Demartines Nicolas, Professeur study chair
CHUV University Hospitals of Lausanne
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 Carcinoma, Hepatocellular and Alcoholic Cirrhosis, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 1 inclusion and 3 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 13 Nov 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 Switzerland. 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?
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?
concordance rate between ICGR-15 and Portal Pressure values in patients with resectable HCC and cirrhosis Child A from alcoholic and non-alcoholic origin. (time frame: 1 year). 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 NCT00827723, which also lists 6 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 13 Nov 2018.