International Liver Surgery Outcomes Study

Completed

• Conditions: Liver Diseases
• Interventions: Procedure: Liver surgery

• Registration Number: NCT03768141
• Lead Sponsor: Royal Free Hospital NHS Foundation Trust

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-07
• Study Start: 2019-01-01
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

• 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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Liver surgery	Liver surgery	Any type of liver surgery

Primary Outcome Measures

Name	Time	Method
Mortality rate	From operation until 90 days postoperatively	Death

Secondary Outcome Measures

Name	Time	Method
Liver failure rate	From operation until 90 days postoperative	Posthepatectomy liver failure will be assessed according to the FABIB Classification, the "International Study Group of Liver Surgery" (ISGLS) criteria as well as the 50-50 criteria up to 90 days postoperatively.
Complication rate	From operation until 90 days postoperatively	Postoperative complications according the the Clavien-Dindo classification, the "liver Failure, Ascites, Bile leakage, Infection, Bleeding" (FABIB) liver specific classification, as well as the novel Comprehensive Complications Index® (CCI® ).
Re-hospitalisation rate	From operation until 90 days postoperatively	Readmission to any hospital
Hospital stay	From operation until discharge from the hospital or up to 90 days postoperatively.	The length of hospital stay is defined as the duration of hospitalization from the day of the operation until the day of discharge from the hospital.

Trial Locations

Locations (2)

Royal Free Hospital; 🇬🇧 London, United Kingdom

University of Zaragoza, Spain; 🇪🇸 Zaragoza, Spain