Safety and Economics of Parenchymal Transection in Minimally Invasive Liver Surgery

NCT07750275 | Enrolling By Invitation DMC

• 1 other identifier: 29501
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Liver Surgery; Liver Neoplasm; MINIMALLY INVASIVE LIVER SURGERY

Keywords

LIVER TRANSECTION DEVICES

Outcome Measures

Primary Outcomes (1)

• 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;

  January 2021 to December 2025

Study Arms (1)

Patients underwent minimally invasive liver transection

Comparison among liver transection devices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participation is open to centres with an annual MILS volume ≥20 cases/year, or \>10 cases/year if operating as a dedicated HPB unit. A minimum of 15 centres is required, with a target of more than 30 centres distributed across the three Italian macro-areas (North, Centre, South), with possible international participation. Each centre completes a standardised electronic case report form (e-CRF) and contributes consecutive eligible cases. Table 1 shows elegibility criteria. Consecutive eligible procedures performed between January 2021 and December 2025 are included. To control for the robotic HPB learning curve, the first 65 robotic cases of each centre are excluded, consistent with the published learning-curve evidence. This safeguards the robotic and hybrid comparisons against early-experience confounding.

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Molise: lead

Study Sites (1)

University of Molise

Campobasso, CB, 86100, Italy

Location

Related Publications (1)

• 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/s00464-025-11769-3. Epub 2025 Jun 16.

  PMID: 40523976 RESULT

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate, Technologies and Innovations in Medicine

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: August 6, 2026
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)