International Liver Surgery Outcomes Study (LiverGroup)

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Diseases
• Intervention / Treatment: Procedure: Liver surgery

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 Type: Observational
• Enrollment (Actual): 2500

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50009
    • University of Zaragoza, Spain
• United Kingdom
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any adult patient undergoing liver surgery.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Liver surgery; Any type of liver surgery

Procedure: Liver surgery; 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 portal vein embolization (PVE), portal vein ligation (PVL), "Associating Liver Partition and Portal vein Ligation for Staged hepatectomy" (ALPPS), resections involving cold perfusion (ex-situ and ante-situ)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate	Death	From operation until 90 days postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	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® ).	From operation until 90 days postoperatively
Liver failure rate	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.	From operation until 90 days postoperative
Hospital stay	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.	From operation until discharge from the hospital or up to 90 days postoperatively.
Re-hospitalisation rate	Readmission to any hospital	From operation until 90 days postoperatively

Collaborators and Investigators

• Sponsor: Royal Free Hospital NHS Foundation Trust
• Collaborators: Hospital Miguel Servet
• Investigators: Principal Investigator: Massimo Malagò, MD, PhD, Royal Free Hospital, London, UK

Publications and helpful links

Helpful Links

• The official clinical trial management system (CTMS) of LiverGroup.org
• Cloud Graphical User Interface for R Statistics - Statistical software for data analysis

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Surgery; Outcomes; International; Liver; Snapshot; Collaborative
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: v.1.3.2011.11.30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The datasets generated and analysed during the current study will be available upon request from the Management Committee of LiverGroup.org. The study Primary Investigators will act as the custodians of the data. The data, however, belong to all collaborators. The Steering and Management committees together will decide after the publication of the main report about requests regarding secondary analysis and will consider all such requests based on quality and the validity of the proposed project and decide by majority decision. All data provided will be fully anonymized without any patient identifiers.
• IPD Sharing Time Frame: The data will become available after the completion and publication of the first study generated by LiverGroup.org
• IPD Sharing Access Criteria: The steering and management committees together will decide after the publication of the main report about requests regarding secondary analysis and will consider all such requests based on quality and the validity of the proposed project and decide by majority decision.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No