Hepatocellular CarcinomaNCT01715402
Optimization of Health Expenditure in Liver Surgery
An observational study of Hepatocellular Carcinoma and Hilar Cholangiocarcinoma, run by Centre Hospitalier Universitaire, Amiens at 11 sites in France.
Trial summary
The aim of this study is to reduce the length of stay after liver surgery by taking account of objective quantitative clinical variables, subjective qualitative clinical variables and non clinical variables. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Hilar Cholangiocarcinoma, Intra Hepatic Cholangiocarcinoma
- What is being tested?
- liver surgery
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 11 sitesFrance
- Study dates
- 30 Sep 2012to 30 Sep 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the population corresponds to patients operated in one of the thirteen hospitals. These hospitals are distributed on the french territory to ensure that the recruitment is representative of the general population
Who may be able to join
- elective liver surgery
- older than 18
- agreed to participate
- surgical procedure included procedures registered as "HLFA003 - 007 ; 009 - 011 ; 017 - 020 ; HLFC002 à 004 ; 027 ; 032 ; 037" in the PMSI database
Who cannot join
- emergency surgery
- refused to participate
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Amiens North Hospital
Amiens
Bordeaux Hospital
Bordeaux
Beaujon University Hospital
Clichy
Lille Regional Hospital
Lille
Lyon Hospital
Lyon
Marseille Hospital
Marseille
Paoli calmette institute
Marseille
Saint Antoine Hospital
Paris
Strasbourg hospital
Strasbourg
Gustave Roussy institute
Villejuif
Paul Brousse Hospital
Villejuif
About this study
Official title: Optimization of Health Expenditure in Major Surgery: Impact of a Mixed, Clinical and Ethnographic Approach in the Model of Liver Surgery
The aim of this study is to reduce the length of stay after liver surgery by taking account of objective quantitative clinical variables, subjective qualitative clinical variables and non clinical variables.
Read the detailed description
a new dimension of the activity expected of physicians is to improve the safety of care on the one hand and the control of health care costs on the other.
key measures to help them are the publication of national recommendations, assessment of actual practices and the incentive to activity.
Internationalwide recent and concordant data suggest that
- quality and security of care, after an initial improvement, are going to stall
- scientific recommendations are rarely validated by an impact analysis and are not applied
- clinical data collected within an administrative framework are unreliable and too generalist
- the evaluation, especially in the surgical field, is based on indicators sometimes irrelevant and often unclear
- Conditions
- Hepatocellular Carcinoma, Hilar Cholangiocarcinoma, Intra Hepatic Cholangiocarcinoma, Liver Metastasis
- Being tested
- liver surgery
- Keywords
- liver tumor, carcinoma, cholangiocarcinoma, metastasis
- Medical subject headings
- Carcinoma, Hepatocellular, Klatskin Tumor, Carcinoma, Cholangiocarcinoma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liver surgeryProcedure or surgery
this intervention type includes hepatectomies; wedge; segmentectomies etc...
| Study group | Role | What they receive |
|---|---|---|
| operated patients | this cohort includes patients who underwent a liver surgery whatever the pathology and whatever the surgical procedure Receives: Procedure: liver surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall postoperative length of stay
the overall postoperative length of stay is defined as the hospitalization between the surgery and patient's discharge.
This period includes the readmission for at least 24 hours in case of outcomes related to the surgery.
Measured: during the 3 months after the surgery
Secondary outcomes (4)
peroperative outcomes
the peroperative outcomes are collected during the surgery and correspond to any event occured during the surgical intervention
Measured: during the surgical procedure
postoperative outcomes
the postoperative outcomes correspond to any event occured after the surgical intervention. These outcomes include fistulae; bleeding...
Measured: after the surgery until postoperative month 3
construct of pronostic models
the construct of pronostic models include variables that affect the length of stay; morbidity and mortality
Measured: after the postoperative month 3
evaluation of PMSI indicators
this evaluation includes the analysis of PMSI indicators; their validity and the influence of centres on hepatectomies results
Measured: after the postoperative month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study start30 Sep 2012
- Primary completion30 Sep 2015
- Study completion30 Sep 2015
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 Centre Hospitalier Universitaire, AmiensThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
- Investigators
- Olivier FARGES, MD, phD, Principal investigator, Beaujon University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715402
- Sponsor's protocol ID
- AOM 11060 PHRCN08-PR-REGIMBEAU
- Status last verified
- Feb 2017
- First submitted
- 22 Oct 2012
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Cauchy F, Farges O, Vibert E, Boleslawski E, Pruvot FR, Regimbeau JM, Mabrut JY, Scatton O, Adham M, Laurent C, Gregoire E, Delpero JR, Bachellier P, Soubrane O. Sensitizing Surgeons to Their Outcome Has No Measurable Short-term Benefit. Ann Surg. 2017 Nov;266(5):884-889. doi: 10.1097/SLA.0000000000002403.
PubMed 28991876
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Health Expenditure in Major Surgery: Impact of a Mixed, Clinical and Ethnographic Approach in the Model of Liver Surgery
- ClinicalTrials.gov ID
- NCT01715402
- Acronym / sponsor ID
- AOM 11060 PHRCN08-PR-REGIMBEAU
- Conditions
- Hepatocellular Carcinoma, Hilar Cholangiocarcinoma, Intra Hepatic Cholangiocarcinoma, Liver Metastasis
- Keywords
- liver tumor, carcinoma, cholangiocarcinoma, metastasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- 30 Sep 2012 (actual)
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- 30 Sep 2015 (actual)
- First posted
- 29 Oct 2012 (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 this study is to reduce the length of stay after liver surgery by taking account of objective quantitative clinical variables, subjective qualitative clinical variables and non clinical variables.
Detailed description
a new dimension of the activity expected of physicians is to improve the safety of care on the one hand and the control of health care costs on the other.
key measures to help them are the publication of national recommendations, assessment of actual practices and the incentive to activity.
Internationalwide recent and concordant data suggest that
- quality and security of care, after an initial improvement, are going to stall
- scientific recommendations are rarely validated by an impact analysis and are not applied
- clinical data collected within an administrative framework are unreliable and too generalist
- the evaluation, especially in the surgical field, is based on indicators sometimes irrelevant and often unclear
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| operated patients | – | Procedure: liver surgerythis cohort includes patients who underwent a liver surgery whatever the pathology and whatever the surgical procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the population corresponds to patients operated in one of the thirteen hospitals. These hospitals are distributed on the french territory to ensure that the recruitment is representative of the general population
Key inclusion criteria (4 listed)
- elective liver surgery
- older than 18
- agreed to participate
- surgical procedure included procedures registered as "HLFA003 - 007 ; 009 - 011 ; 017 - 020 ; HLFC002 à 004 ; 027 ; 032 ; 037" in the PMSI database
Key exclusion criteria (2 listed)
- emergency surgery
- refused to participate
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 surgerythis intervention type includes hepatectomies; wedge; segmentectomies etc... | Procedure or surgery | operated patients |
Primary outcome
overall postoperative length of stay
Time frame: during the 3 months after the surgery
the overall postoperative length of stay is defined as the hospitalization between the surgery and patient's discharge. This period includes the readmission for at least 24 hours in case of outcomes related to the surgery.
4 secondary outcomes
peroperative outcomes
Time frame: during the surgical procedure
postoperative outcomes
Time frame: after the surgery until postoperative month 3
construct of pronostic models
Time frame: after the postoperative month 3
evaluation of PMSI indicators
Time frame: after the postoperative month 3
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 24 Jun 2026.
- Derived from this study: PubMed 28991876Cauchy F, Farges O, Vibert E, Boleslawski E, Pruvot FR, Regimbeau JM, Mabrut JY, Scatton O, Adham M, Laurent C, Gregoire E, Delpero JR, Bachellier P, Soubrane O. Sensitizing Surgeons to Their Outcome Has No Measurable Short-term Benefit. Ann Surg. 2017 Nov;266(5):884-889. doi: 10.1097/SLA.0000000000002403.
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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.
Olivier FARGES, MD, phD principal investigator
Beaujon University Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Hilar Cholangiocarcinoma, run by Centre Hospitalier Universitaire, Amiens at 11 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 4 inclusion and 2 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 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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. 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?
overall postoperative length of stay (time frame: during the 3 months after the surgery). 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 NCT01715402, 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 24 Jun 2026.