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Completed

NCT Number: NCT03768141

International Liver Surgery Outcomes Study

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.

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Key information

Conditions

Liver Diseases Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Zaragoza, Spain, Zaragoza, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liver Surgery

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)

Primary outcomes

  1. Mortality rate

    Time frame: From operation until 90 days postoperatively

    Death

Secondary outcomes

  1. Complication rate

    Time frame: 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® ).

  2. Liver failure rate

    Time frame: 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.

  3. Hospital stay

    Time frame: 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.

  4. Re-hospitalisation rate

    Time frame: From operation until 90 days postoperatively

    Readmission to any hospital

Sponsors and collaborators

Lead sponsor

Royal Free Hospital NHS Foundation Trust

Other

Collaborators

  • Hospital Miguel Servet

Registry information

Official study title

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

Acronym: LiverGroup

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 7, 2018
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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