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Trial Title:
Impact of a European Training Program for Robotic Liver Surgery (LIVEROBOT)
NCT ID:
NCT05723705
Condition:
Liver Diseases
Liver Neoplasm
Liver Cancer
Liver Metastases
Biliary Tract Cancer
Biliary Tract Neoplasms
Biliary Tract Diseases
Conditions: Official terms:
Neoplasms
Liver Neoplasms
Biliary Tract Neoplasms
Liver Diseases
Biliary Tract Diseases
Liver Extracts
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
European Multicentre Training Program for Robotic Liver Surgery
Description:
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.
Other name:
Robotic Liver Surgery
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.
Criteria for eligibility:
Study pop:
Patients are 18 years or above who are eligible to undergo a robotic hepatectomy for
accepted indications.
Sampling method:
Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Amsterdam UMC, location VUmc
Agency class:
Other
Collaborator:
Agency:
UMC Utrecht
Agency class:
Other
Collaborator:
Agency:
General Hospital Groeninge
Agency class:
Other
Collaborator:
Agency:
Fondazione Poliambulanza Istituto Ospedaliero
Agency class:
Other
Collaborator:
Agency:
Intuitive Surgical
Agency class:
Industry
Source:
Amsterdam UMC, location VUmc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05723705
