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

Study Overview
=================
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.

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

Conditions
-----------------
Liver Diseases, Liver Neoplasm, Liver Cancer, Liver Metastases, Biliary Tract Cancer, Biliary Tract Neoplasms, Biliary Tract Diseases

Intervention / Treatment
-----------------
* Other: European Multicentre Training Program for Robotic Liver Surgery


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

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 |