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International Liver Surgery Outcomes Study

NCT ID: NCT03768141

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-03-31

Brief Summary

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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

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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.

Conditions

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Liver Diseases

Keywords

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Liver Surgery Outcomes Snapshot Collaborative International

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Liver surgery

Any type of liver surgery

Liver surgery

Intervention Type PROCEDURE

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)

Interventions

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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)

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Exclusion Criteria

* Liver transplantation
* Imaging-guided liver ablation techniques alone
* Liver biopsies
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Miguel Servet

OTHER

Sponsor Role collaborator

Royal Free Hospital NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Dimitri Raptis

Senior Clinical Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Massimo Malagò, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Royal Free Hospital, London, UK

Locations

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University of Zaragoza, Spain

Zaragoza, , Spain

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

Countries

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Spain United Kingdom

References

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LiverGroup.org Collaborative*. Outcomes of elective liver surgery worldwide: a global, prospective, multicenter, cross-sectional study. Int J Surg. 2023 Dec 1;109(12):3954-3966. doi: 10.1097/JS9.0000000000000711.

Reference Type DERIVED
PMID: 38258997 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://www.rBiostatistics.com

Cloud Graphical User Interface for R Statistics - Statistical software for data analysis

Other Identifiers

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v.1.3.2011.11.30

Identifier Type: -

Identifier Source: org_study_id