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

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 Overview

• Status: Not yet recruiting
• Conditions: Liver Diseases; Biliary Tract Diseases; Liver Metastases; Liver Neoplasm; Biliary Tract Neoplasms; Liver Cancer; Biliary Tract Cancer
• Intervention / Treatment: Other: European Multicentre Training Program for Robotic Liver Surgery

• Study Type: Observational
• Enrollment (Anticipated): 3600

Contacts and Locations

• Study Contact: Name: Gabriela Pilz da Cunha, MD; Phone Number: 020 444 4444; Email: g.pilzdacunha@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients are 18 years or above who are eligible to undergo a robotic hepatectomy for accepted indications.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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+)	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.	30 days
Performance grading using the modified OSATS score	As assessed by the proctors through video-review	2 years (expected)
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

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Collaborators: UMC Utrecht; General Hospital Groeninge; Intuitive Surgical; Fondazione Poliambulanza Istituto Ospedaliero

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Neoplasms; Liver Neoplasms; Biliary Tract Neoplasms; Biliary Tract Diseases; Hematinics; Liver Extracts
• Other Study ID Numbers: LIVEROBOT; W22_217 # 22.269 (Other Identifier: METC Amsterdam UMC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No