Liver DiseasesLIVEROBOTNCT05723705
Impact of a European Training Program for Robotic Liver Surgery (LIVEROBOT)
An observational study of Liver Diseases and Liver Neoplasm, run by Amsterdam UMC, location VUmc.
Trial summary
LIVEROBOT is a collaboration of high-volume liver surgical centers in Europe (≥60 liver resections per year), supported by the European-African Hepato-Pancreato-Biliary Association Education Committee (E-AHPBA), and the European Registry of Minimally Invasive Liver Surgery (E-MILS) aiming to support the step-up… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases, Liver Neoplasm, Liver Cancer
- What is being tested?
- European Multicentre Training Program for Robotic Liver Surgery
- How many people
- 3,600 participants
- Where
- No sites listed yet
- Study dates
- Apr 2023to Dec 2025
- 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: Patients are 18 years or above who are eligible to undergo a robotic hepatectomy for accepted indications.
Who may be able to join
- Age equal or above 18 years
- Eligible for elective minimally invasive and open hepatectomy for malignant, pre-malignant or benign disease located in the liver or biliary tract
- Eligible for both minimally invasive and open surgery according to the operating surgeon
- Fit to undergo the indicated operation according to both the anaesthesiologist and surgeon
Who cannot join
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
LIVEROBOT is a collaboration of high-volume liver surgical centers in Europe (≥60 liver resections per year), supported by the European-African Hepato-Pancreato-Biliary Association Education Committee (E-AHPBA), and the European Registry of Minimally Invasive Liver Surgery (E-MILS) aiming to support the step-up implementation and safety of advanced surgical expertise of robotic liver surgery (RLS) on a European basis. The LIVEROBOT training program aims to promote the safe implementation of RLS throughout Europe. The data from all patients operated on during a surgeons' participation in the training program will be prospectively gathered allowing for learning curve and outcome analyses.
- Conditions
- Liver Diseases, Liver Neoplasm, Liver Cancer, Liver Metastases, Biliary Tract Cancer, Biliary Tract Neoplasms
- Being tested
- European Multicentre Training Program for Robotic Liver Surgery
- Medical subject headings
- Liver Diseases, Liver Neoplasms, Biliary Tract Neoplasms, Biliary Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
European Multicentre Training Program for Robotic Liver SurgeryOther
Also called Robotic Liver Surgery
LIVEROBOT is a pan-european multicentre training program for robotic liver surgery involving simulation training, a procedure video-library, on and off-site proctoring, and video-assessment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Textbook Outcome in Liver Surgery (TOLS)
TOLS is a novel composite measure that captures the most desirable surgical outcomes into a single indicator and is defined as the absence of intraoperative incidents of grade ≥ 2 (defined according to the Oslo classification), postoperative bile leakage of grade B or C (according to the severity grading of the International Study Group of Liver Surgery), Clavien-Dindo ≥ Grade 3 complications, 30-day readmission, in-hospital mortality and the presence of R0 resection margin.
Measured: 30 days
Secondary outcomes (8)
CUSUM operative time (Learning curve)
Measured: After completion of 50 minor and 50 major robotic liver surgery cases per surgeon
Textbook Outcome in Liver Surgery + (TOLS+)
TOLS+ is an extended definition of TOLS and includes the same variables as TOLS but adds 'prolonged LOS' defined as > 4 days for minor RLS and > 7 days for major RLS.
Measured: 30 days
Performance grading using the modified OSATS score
As assessed by the proctors through video-review
Measured: 2 years (expected)
Conversion to open surgery
Measured: at operation completion
Estimated operative blood loss
Measured: at operation completion
Blood transfusions
Measured: at operation completion
Length of Hospital Stay
Measured: Expected 4-10 days depending on if minor or major liver resection
Intra-operative ICG-margin assessment
Measured: at operation completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study startApr 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, General Hospital Groeninge, Fondazione Poliambulanza Istituto Ospedaliero, Intuitive Surgical
- Responsible party
- Principal investigator, Dr. R.J. (Rutger-Jan) Swijnenburg, Amsterdam UMC, location VUmc
- Investigators
- Rutger-Jan Swijnenburg, MD PhD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Jeroen Hagendoorn, MD PhD, Principal investigator, UMC UtrechtMathieu d'Hondt, MD PhD, Principal investigator, AZ GroeningeMohammed Abu Hilal, MD PhD, Principal investigator, Poliambulanza Foundation Hospital Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723705
- Sponsor's protocol ID
- LIVEROBOT
- Other IDs
- W22_217 # 22.269
- Acronym
- LIVEROBOT
- Status last verified
- Mar 2023
- First submitted
- 25 Jan 2023
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a European Training Program for Robotic Liver Surgery (LIVEROBOT)
- ClinicalTrials.gov ID
- NCT05723705
- Acronym / sponsor ID
- LIVEROBOT / LIVEROBOT
- Conditions
- Liver Diseases, Liver Neoplasm, Liver Cancer, Liver Metastases, Biliary Tract Cancer, Biliary Tract Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- UMC Utrecht, General Hospital Groeninge, Fondazione Poliambulanza Istituto Ospedaliero, Intuitive Surgical
- Study start
- Apr 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Feb 2023 (actual)
- 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.
LIVEROBOT is a collaboration of high-volume liver surgical centers in Europe (≥60 liver resections per year), supported by the European-African Hepato-Pancreato-Biliary Association Education Committee (E-AHPBA), and the European Registry of Minimally Invasive Liver Surgery (E-MILS) aiming to support the step-up implementation and safety of advanced surgical expertise of robotic liver surgery (RLS) on a European basis. The LIVEROBOT training program aims to promote the safe implementation of RLS throughout Europe. The data from all patients operated on during a surgeons' participation in the training program will be prospectively gathered allowing for learning curve and outcome analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are 18 years or above who are eligible to undergo a robotic hepatectomy for accepted indications.
Key inclusion criteria (4 listed)
- Age equal or above 18 years
- Eligible for elective minimally invasive and open hepatectomy for malignant, pre-malignant or benign disease located in the liver or biliary tract
- Eligible for both minimally invasive and open surgery according to the operating surgeon
- Fit to undergo the indicated operation according to both the anaesthesiologist and surgeon
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| European Multicentre Training Program for Robotic Liver SurgeryAlso: Robotic Liver SurgeryLIVEROBOT is a pan-european multicentre training program for robotic liver surgery involving simulation training, a procedure video-library, on and off-site proctoring, and video-assessment. | Other | – |
Primary outcome
Textbook Outcome in Liver Surgery (TOLS)
Time frame: 30 days
TOLS is a novel composite measure that captures the most desirable surgical outcomes into a single indicator and is defined as the absence of intraoperative incidents of grade ≥ 2 (defined according to the Oslo classification), postoperative bile leakage of grade B or C (according to the severity grading of the International Study Group of Liver Surgery), Clavien-Dindo ≥ Grade 3 complications, 30-day readmission, in-hospital mortality and the presence of R0 resection margin.
8 secondary outcomes
CUSUM operative time (Learning curve)
Time frame: After completion of 50 minor and 50 major robotic liver surgery cases per surgeon
Textbook Outcome in Liver Surgery + (TOLS+)
Time frame: 30 days
Performance grading using the modified OSATS score
Time frame: 2 years (expected)
Conversion to open surgery
Time frame: at operation completion
Estimated operative blood loss
Time frame: at operation completion
Blood transfusions
Time frame: at operation completion
Length of Hospital Stay
Time frame: Expected 4-10 days depending on if minor or major liver resection
Intra-operative ICG-margin assessment
Time frame: at operation completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Rutger-Jan Swijnenburg, MD PhD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Jeroen Hagendoorn, MD PhD principal investigator
UMC Utrecht
Mathieu d'Hondt, MD PhD principal investigator
AZ Groeninge
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases and Liver Neoplasm, run by Amsterdam UMC, location VUmc.
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 1 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 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Gabriela Pilz da Cunha, MD (020 444 4444, g.pilzdacunha@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Textbook Outcome in Liver Surgery (TOLS) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2023.