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

Amsterdam UMC, location VUmc

Status: Not yet enrolling

Conditions: Biliary Tract Cancer; Biliary Tract Neoplasms; Liver Neoplasm; Liver Metastases; Liver Cancer; Biliary Tract Diseases; Liver Diseases

Treatments: Other: European Multicentre Training Program for Robotic Liver Surgery

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05723705

W22_217 # 22.269 (Other Identifier)

LIVEROBOT

Details and patient eligibility

About

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.

Enrollment: 3,600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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