Impact of a European Training Program for Robotic Liver Surgery (LIVEROBOT)

Sponsor

Amsterdam UMC, location VUmc (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05723705

Collaborator

UMC Utrecht (Other), General Hospital Groeninge (Other), Fondazione Poliambulanza Istituto Ospedaliero (Other), Intuitive Surgical (Industry)

3,600

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Diseases Liver Neoplasm Liver Cancer Liver Metastases Biliary Tract Cancer Biliary Tract Neoplasms Biliary Tract Diseases	Other: European Multicentre Training Program for Robotic Liver Surgery

Study Design

Study Type:

Observational

Anticipated Enrollment :

3600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Impact of a European Training Program for Robotic Liver Surgery (LIVEROBOT)

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Outcome Measures

Primary Outcome Measures

Textbook Outcome in Liver Surgery (TOLS) [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.

Secondary Outcome Measures

CUSUM operative time (Learning curve) [After completion of 50 minor and 50 major robotic liver surgery cases per surgeon]
Textbook Outcome in Liver Surgery + (TOLS+) [30 days]
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.
Performance grading using the modified OSATS score [2 years (expected)]
As assessed by the proctors through video-review
Conversion to open surgery [at operation completion]
Estimated operative blood loss [at operation completion]
Blood transfusions [at operation completion]
Length of Hospital Stay [Expected 4-10 days depending on if minor or major liver resection]
Intra-operative ICG-margin assessment [at operation completion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Amsterdam UMC, location VUmc
UMC Utrecht
General Hospital Groeninge
Fondazione Poliambulanza Istituto Ospedaliero
Intuitive Surgical

Investigators

Principal Investigator: Rutger-Jan Swijnenburg, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Principal Investigator: Jeroen Hagendoorn, MD PhD, UMC Utrecht
Principal Investigator: Mathieu d'Hondt, MD PhD, AZ Groeninge
Principal Investigator: Mohammed Abu Hilal, MD PhD, Poliambulanza Foundation Hospital Brescia