跳至主要内容
临床试验/NCT03768141
NCT03768141已完成不适用

International Study on the Outcomes of Liver Surgery - LiverGroup.Org

Royal Free Hospital NHS Foundation Trust2 个研究点 分布在 2 个国家目标入组 2,500 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,500
试验地点
2
主要终点
Mortality rate

研究概览

简要总结

This study was to designed to measure the true worldwide practice of liver surgery and associated outcomes by recruiting multiple international centres, committing to consecutive patient registration per surgeon and undergo rigorous data validation. It is hoped that these data will provide a more appropriate guide to inform surgeons and patients to assess which level of complexity should be routinely offered for high tumour burden and anatomically difficult scenarios.

详细描述

Liver surgery was associated with at least 10% mortality in the 1970's. The safety of liver surgery has dramatically improved since with a mortality of now around 1-2%. Individual centres postulate that a perioperative mortality close to 0% should be the standard of major liver resection. Despite these claims, epidemiological studies showed a mortality rate of 6%. Outcomes in liver surgery are likely influenced by indications, complexity, centre and surgeon skills, equipment, centre and surgeon experience. The aim of LiverGroup.org is to develop an international data set on the outcomes of liver resections among a large number of international surgeons. The 'collaborative' model for 'snapshot' clinical audit is now well established and such research is a novel approach for assessing current practice in a short period of time. The primary objective of the study is to provide a verified record of the true perioperative morbidity and mortality of a representative set of liver surgeons worldwide in 2019. Secondary objectives include risk factors for mortality and morbidity using multivariable regression models. Any surgeon performing liver resections is eligible to participate in LiverGroup.org. All consecutive cases will be included and there are no minimum patient numbers per centre. Liver transplantation is excluded. There will be 3 months of prospective patient enrolment and 3 months follow up within the 12-month frame, January to December 2019. All liver resections, all indications, as well as all co-morbidities will be included. Liver transplantation, imaging-guided ablations and liver biopsies are excluded.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • All indications (including benign and living donor resections)
  • All co-morbidities
  • Open, laparoscopic or robotic
  • Single wedge resections to extended liver resections
  • Single or two-stage hepatectomies
  • Procedures with liver volume enhancement such as PVE, PVL, ALPPS.
  • Resections involving cold perfusion (ex-situ and ante-situ)
  • There are no exclusion criteria as related to indication, age or comorbidities.

排除标准

  • Liver transplantation
  • Imaging-guided liver ablation techniques alone
  • Liver biopsies

结局指标

主要结局

Mortality rate

时间窗: From operation until 90 days postoperatively

Death

次要结局

  • Liver failure rate(From operation until 90 days postoperative)
  • Complication rate(From operation until 90 days postoperatively)
  • Re-hospitalisation rate(From operation until 90 days postoperatively)
  • Hospital stay(From operation until discharge from the hospital or up to 90 days postoperatively.)

研究者

发起方
Royal Free Hospital NHS Foundation Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dimitri Raptis

Senior Clinical Fellow

Royal Free Hospital NHS Foundation Trust

研究点 (2)

Loading locations...

相似试验

International Liver Surgery Outcomes Study | 临床试验