ComplicationsNCT01471262
Right Hepatectomy in Patients Beyond 70 Years Old
An observational study of Complications and Liver Failure, Acute, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
As a consequence of the increase in life expectancy, hepato-biliary surgeons have to deal with an emerging aged population, which has a potential higher risk for complication and worse long-term outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complications, Liver Failure, Acute
- What is being tested?
- Right hepatectomy and Extended right hepatectomy
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2006to Dec 2011
- 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: All patients that will undergo right or extended right hepatectomy for benign or malignant diseases.
Who may be able to join
- Age >= 18 years
- Elective right hepatectomy
- Elective extended right hepatectomy
Who cannot join
- Age < 18 years
- Pregnancy
- Other type of hepatectomy
- Emergency hepatectomy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Visceral Surgery, University Hospital CHUV
Lausanne, CH-1012
About this study
Official title: Right and Extended Right Hepatectomy in Patients Beyond 70 Years of Age - Liver Function and Outcome
As a consequence of the increase in life expectancy, hepato-biliary surgeons have to deal with an emerging aged population, which has a potential higher risk for complication and worse long-term outcome. The investigators will be analyzing the liver function and outcome after right or extended right hepatectomy in patients over 70 years old.
- Conditions
- Complications, Liver Failure, Acute
- Being tested
- Right hepatectomy, Extended right hepatectomy
- Keywords
- Complications, Mortality, Liver, Failure
- Medical subject headings
- Liver Failure, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right hepatectomyProcedure or surgery
Also called Liver surgery
Right liver resection
Extended right hepatectomyProcedure or surgery
Also called Liver surgery
Right hepatectomy involving 5 or more segments
| Study group | Role | What they receive |
|---|---|---|
| Elderly | Patients more or equal to 70 years old Receives: Procedure: Right hepatectomy; Procedure: Extended right hepatectomy | |
| Young | Patients less than 70 years old Receives: Procedure: Right hepatectomy; Procedure: Extended right hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity
Any type of complication defined according to the Clavien-Dindo Classification of surgical complications.
Measured: 90 days
Secondary outcomes (3)
Mortality
Patient death occuring 90 days post-operatively
Measured: 90 days
Liver failure
Defined according to the Belghiti 50-50 criteria for liver failure.
Measured: 90 days
Hospital stay
Total hospital stay (including re-admission hospital stay) in days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2011 (estimated)
- Study startJan 2006
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ComplicationsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Principal investigator, Dr. Emmanuel Melloul, Centre Hospitalier Universitaire Vaudois
- Investigators
- Emmanuel Melloul, MD, Principal investigator, Department of Visceral Surgery, University Hospital CHUV, Lausanne, SwitzerlandNicolas Demartines, MD, Study chair, Department of Visceral Surgery, University Hospital CHUV, Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471262
- Sponsor's protocol ID
- CHV080501
- Status last verified
- Nov 2011
- First submitted
- 10 Nov 2011
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
PubMed 19638912Paugam-Burtz C, Janny S, Delefosse D, Dahmani S, Dondero F, Mantz J, Belghiti J. Prospective validation of the "fifty-fifty" criteria as an early and accurate predictor of death after liver resection in intensive care unit patients. Ann Surg. 2009 Jan;249(1):124-8. doi: 10.1097/SLA.0b013e31819279cd.
PubMed 19106687
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Right and Extended Right Hepatectomy in Patients Beyond 70 Years of Age - Liver Function and Outcome
- ClinicalTrials.gov ID
- NCT01471262
- Acronym / sponsor ID
- CHV080501
- Conditions
- Complications, Liver Failure, Acute
- Keywords
- Complications, Mortality, Liver, Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- Jan 2006
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 15 Nov 2011 (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.
As a consequence of the increase in life expectancy, hepato-biliary surgeons have to deal with an emerging aged population, which has a potential higher risk for complication and worse long-term outcome. The investigators will be analyzing the liver function and outcome after right or extended right hepatectomy in patients over 70 years old.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly | – | Procedure: Right hepatectomy, Procedure: Extended right hepatectomyPatients more or equal to 70 years old |
| Young | – | Procedure: Right hepatectomy, Procedure: Extended right hepatectomyPatients less than 70 years old |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that will undergo right or extended right hepatectomy for benign or malignant diseases.
Key inclusion criteria (3 listed)
- Age >= 18 years
- Elective right hepatectomy
- Elective extended right hepatectomy
Key exclusion criteria (4 listed)
- Age < 18 years
- Pregnancy
- Other type of hepatectomy
- Emergency hepatectomy
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 |
|---|---|---|
| Right hepatectomyAlso: Liver surgeryRight liver resection | Procedure or surgery | Elderly, Young |
| Extended right hepatectomyAlso: Liver surgeryRight hepatectomy involving 5 or more segments | Procedure or surgery | Elderly, Young |
Primary outcome
Morbidity
Time frame: 90 days
Any type of complication defined according to the Clavien-Dindo Classification of surgical complications.
3 secondary outcomes
Mortality
Time frame: 90 days
Liver failure
Time frame: 90 days
Hospital stay
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
- Background: PubMed 19638912Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
- Background: PubMed 19106687Paugam-Burtz C, Janny S, Delefosse D, Dahmani S, Dondero F, Mantz J, Belghiti J. Prospective validation of the "fifty-fifty" criteria as an early and accurate predictor of death after liver resection in intensive care unit patients. Ann Surg. 2009 Jan;249(1):124-8. doi: 10.1097/SLA.0b013e31819279cd.
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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.
Emmanuel Melloul, MD principal investigator
Department of Visceral Surgery, University Hospital CHUV, Lausanne, Switzerland
Nicolas Demartines, MD study chair
Department of Visceral Surgery, University Hospital CHUV, Lausanne, Switzerland
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 Complications and Liver Failure, Acute, run by Centre Hospitalier Universitaire Vaudois 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Nov 2011. 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?
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?
Morbidity (time frame: 90 days). 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 NCT01471262, which also lists 2 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 22 Nov 2011.