Clinical trial NCT05723705: Impact of a European Training Program for Robotic Liver Surgery (LIVEROBOT)
Official title: Impact of a European Training Program for Robotic Liver Surgery (LIVEROBOT)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Liver Diseases
Liver Neoplasm
Liver Cancer
Liver Metastases
Biliary Tract Cancer
Biliary Tract Neoplasms
Biliary Tract Diseases
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: UMC Utrecht
name: General Hospital Groeninge
name: Fondazione Poliambulanza Istituto Ospedaliero
name: Intuitive Surgical
First posted: 2023-02-13
Enrollment: 3600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are 18 years or above who are eligible to undergo a robotic hepatectomy for accepted indications.

Brief 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 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.


Eligibility criteria: Center/Surgeon Eligibility Criteria:

Prior to admission to the LIVEROBOT training program surgeons must demonstrate laparoscopic experience with a laparoscopic cholecystectomy with OSATS score \>3 (reviewed by proctors), participation in the LAELIVE training program or demonstrating more than two-year experience in clinical laparoscopic liver surgery. Additionally, a minimal surgical volume is required for participation. Annual liver surgery volume (open and minimally invasive combined) per two surgeons should be more 60, aiming to reach more than 40 RLS annually. Each participating surgeon should individually perform a minimum of more than 15 hepatectomy procedures annually. Surgeons shall be excluded from the training program if at any point failing to meet the minimal volume criteria (corrected for COVID-19 restrictions).

Inclusion Criteria:

* 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

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Textbook Outcome in Liver Surgery (TOLS)
timeFrame: 30 days
Secondary outcomes:
measure: CUSUM operative time (Learning curve)
timeFrame: After completion of 50 minor and 50 major robotic liver surgery cases per surgeon
measure: Textbook Outcome in Liver Surgery + (TOLS+)
timeFrame: 30 days
measure: Performance grading using the modified OSATS score
timeFrame: 2 years (expected)
measure: Conversion to open surgery
timeFrame: at operation completion
measure: Estimated operative blood loss
timeFrame: at operation completion
measure: Blood transfusions
timeFrame: at operation completion
measure: Length of Hospital Stay
timeFrame: Expected 4-10 days depending on if minor or major liver resection
measure: Intra-operative ICG-margin assessment
timeFrame: at operation completion
Other outcomes:
Locations:
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Rutger-Jan Swijnenburg, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht
name: Jeroen Hagendoorn, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AZ Groeninge
name: Mathieu d'Hondt, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Poliambulanza Foundation Hospital Brescia
name: Mohammed Abu Hilal, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: