Enrolling by invitation NCT07750275

Safety and Economics of Parenchymal Transection in Minimally Invasive Liver Surgery

— Observational Liver Surgery MINIMALLY INVASIVE LIVER SURGERY Liver Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Liver Surgery, MINIMALLY INVASIVE LIVER SURGERY, Liver Neoplasm. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Italy
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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)

Overview

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.

Primary outcome measures

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 [Time frame: January 2021 to December 2025]

Eligibility criteria

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Case-crossover

Study locations

Italy · 1 center

University of Molise — Campobasso

Publications

Ceccarelli G, Avella P, Muttillo EM, Conticchio M, Tebala GD, Piccolo G, Romano L, Memeo R, Rocca A; LIVER-MIND (Minimally Invasive Surgery and pareNchyma transection Devices) Study Group. Devices for minimally invasive liver parenchyma transection: the SICE (Italian Society of Endoscopic Surgery) Italian and International survey. Surg Endosc. 2025 Aug;39(8):4822-4838. doi: 10.1007/s00464-025-1176 PMID 40523976

Identifiers

NCT: NCT07750275 · 29501

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗