Biliary Tract Cancer, Biliary Tract Diseases, Biliary Tract Neoplasms, Liver Cancer, Liver Diseases, Liver Metastases, Liver Neoplasm
Conditions
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.
Interventions
OTHEREuropean 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.
Sponsors
UMC Utrecht
General Hospital Groeninge
Fondazione Poliambulanza Istituto Ospedaliero
Intuitive Surgical
Amsterdam UMC, location VUmc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Textbook Outcome in Liver Surgery (TOLS) | 30 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Textbook Outcome in Liver Surgery + (TOLS+) | 30 days | 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. |
| Performance grading using the modified OSATS score | 2 years (expected) | As assessed by the proctors through video-review |
| Conversion to open surgery | at operation completion | — |
| CUSUM operative time (Learning curve) | After completion of 50 minor and 50 major robotic liver surgery cases per surgeon | — |
| 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 | — |
| Estimated operative blood loss | at operation completion | — |
Contacts
Primary ContactGabriela Pilz da Cunha, MD
Outcome results
None listed