NCT03768141

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

1.2 years

First QC Date

December 3, 2018

Last Update Submit

November 18, 2020

Conditions

Liver Diseases

Keywords

LiverSurgeryOutcomesSnapshotCollaborativeInternational

Outcome Measures

Primary Outcomes (1)

  • Mortality rate

    Death

    From operation until 90 days postoperatively

Secondary Outcomes (4)

  • Complication rate

    From operation until 90 days postoperatively

  • Liver failure rate

    From operation until 90 days postoperative

  • Hospital stay

    From operation until discharge from the hospital or up to 90 days postoperatively.

  • Re-hospitalisation rate

    From operation until 90 days postoperatively

Study Arms (1)

Liver surgery

Any type of liver surgery

Procedure: Liver surgery

Interventions

Liver surgeryPROCEDURE

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)

Liver surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any adult patient undergoing liver surgery.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Zaragoza, Spain

Zaragoza, 50009, Spain

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 38258997DERIVED

Related Links

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Massimo Malagò, MD, PhD

    Royal Free Hospital, London, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Clinical Fellow

Study Record Dates

First Submitted

December 3, 2018

First Posted

December 7, 2018

Study Start

January 1, 2019

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

November 20, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The data will become available after the completion and publication of the first study generated by LiverGroup.org
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.
More information

Locations

GB(1)ES(1)