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

Liver Cancer Clinical Trial

— LIVEROBOT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05723705
• Other study ID #: LIVEROBOT
• Secondary ID: W22_217 # 22.269
• Status: Not yet recruiting
• Start date: April 2023
• Est. completion date: December 2025

Study information

• Verified date: March 2023
• Source: Amsterdam UMC, location VUmc
• Contact: Gabriela Pilz da Cunha, MD
• Phone: 020 444 4444
• Email: g.pilzdacunha[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3600
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Diseases
• Biliary Tract Neoplasms
• Liver Cancer
• Liver Diseases
• Liver Metastases
• Liver Neoplasm
• Liver Neoplasms
• Neoplasms

Intervention

Other:
• European Multicentre Training Program for 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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CUSUM operative time (Learning curve)		After completion of 50 minor and 50 major robotic liver surgery cases per surgeon
Secondary	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
Secondary	Performance grading using the modified OSATS score	As assessed by the proctors through video-review	2 years (expected)
Secondary	Conversion to open surgery		at operation completion
Secondary	Estimated operative blood loss		at operation completion
Secondary	Blood transfusions		at operation completion
Secondary	Length of Hospital Stay		Expected 4-10 days depending on if minor or major liver resection
Secondary	Intra-operative ICG-margin assessment		at operation completion