LIVER-MIND 2 is a multicentre, observational, retrospective registry coordinated by the SICE HPB and Minimally Invasive Surgery Working Group, enrolling consecutive adults undergoing elective minimally invasive (laparoscopic, robotic or hybrid) liver resection between January 2021 and December 2025 across ≥15 high-volume or dedicated centres (target \>30 centres).
LIVER-MIND 2 is a multicentre, observational, retrospective registry coordinated by the SICE HPB and Minimally Invasive Surgery Working Group, enrolling consecutive adults undergoing elective minimally invasive (laparoscopic, robotic or hybrid) liver resection between January 2021 and December 2025 across ≥15 high-volume or dedicated centres (target \>30 centres). The first 65 robotic cases per centre are excluded to account for the robotic HPB learning curve. The primary exposure is the transection strategy/primary device, with the principal contrast between cavitron ultrasonic surgical aspirator (CUSA) and energy devices. The primary outcome is a 90-day composite transection-related complication: significant bleeding (estimated blood loss \>500 mL and/or transfusion and/or reintervention for haemostasis) and/or clinically relevant bile leak (ISGLS grade B-C). Secondary outcomes include conversion, Clavien-Dindo ≥IIIa morbidity, post-hepatectomy liver failure (PHLF), operative time, length of stay, 90-day readmission and mortality, oncological radicality, and direct costs. The target sample size is ≈900 patients (80% power, two-sided α = 0.05, expected composite event rate 12%, minimal clinically relevant difference 5%, 5% drop-out inflation). The primary analysis uses multivariable logistic regression with propensity-score matching and inverse-probability-of-treatment weighting; pre-specified subgroup analyses and a statistical analysis plan are deposited before database lock. An exploratory cost analysis adopts a hospital perspective combining DRG-based standard costing and device-level micro-costing.
Study Type
OBSERVATIONAL
Enrollment
800
University of Molise
Campobasso, CB, Italy
1. Rate of bleeding according to Post-Hepatectomy Haemorrhage (PHH) by International Study Group of Liver Surgery (ISGLS) 2. Rate of bile leak according to ISGLS classification in patients with abdominal drainage and/or undergoing percutaneous drainage
Our retrospective study aims to assess the association between the adopted parenchymal transection strategy and devices and the incidence of the composite transection-related complication. The analysis will be conduct among pre-specified subgroup: Minor (\<3 segments) vs Major (≥3 segments) vs Complex (segments I, IVa, VII, VIII) stratified by IWATE score (low 0-3, intermediate 4-6, advanced 7-10); Cirrhosis (Child-Pugh A vs B) vs steatosis (grade I-II vs III/NASH) vs healthy parenchyma; High volume (\>50 MILS/year) vs low volume but dedicated (10-50 MILS/year); robotic vs. laparoscopic vs. hybrid approach; Malignant (primary vs secondary) vs benign disease The main 90-day postoperative outcomes are: 1. rate of significant bleeding according to Post-Hepatectomy Haemorrhage (PHH) by International Study Group of Liver Surgery (ISGLS); 2. rate of bile leak according to ISGLS classification;
Time frame: January 2021 to December 2025
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.