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临床试验/NCT07750275
NCT07750275Enrolling By Invitation不适用

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)

University of Molise1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
800
试验地点
1
主要终点
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

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.)

研究组 & 干预措施

Patients underwent minimally invasive liver transection

Comparison among liver transection devices

结局指标

主要结局

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

时间窗: 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;

次要结局

未报告次要终点

研究者

发起方
University of Molise
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pasquale Avella

PhD Candidate, Technologies and Innovations in Medicine

University of Molise

研究点 (1)

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