Safety and Economics of Parenchymal Transection in Minimally Invasive Liver Surgery

Safety and Economics of Parenchymal Transection in Minimally Invasive Liver Surgery (LIVER-MIND 2): a Multicentre Retrospective Registry of the Italian Society of Endoscopic Surgery (SICE)

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07750275

Acronym

LIVER-MIND 2

Enrollment

800

Registered

2026-08-06

Start date

2021-01-01

Completion date

2027-12-01

Last updated

2026-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Neoplasm, Liver Surgery, MINIMALLY INVASIVE LIVER SURGERY

Keywords

LIVER TRANSECTION DEVICES

Brief summary

Detailed description

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.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥ 18 years * Elective minimally invasive liver resection * Laparoscopic, robotic or hybrid approach * Benign or malignant disease * Signed informed consent for use of anonymised data * Data completeness ≥ 70% in the CRF

Exclusion criteria

* Urgent or emergency surgery * Liver transplantation (donor / recipient) * Associated major non-hepatic biliary or vascular resection * Lack of consent or follow-up * Participation in conflicting interventional trials * Surgery before January 2021 * Robotic procedures performed during the learning-curve phase (first 65 robotic cases per centre, per Rahimli et al.)

Design outcomes

Primary

Measure	Time frame	Description
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	January 2021 to December 2025	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;

Countries

Italy

Outcome results