Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

International Liver Surgery Outcomes Study (LiverGroup)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03768141
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Hospital Universitario Miguel Servet
Information provided by (Responsible Party):
Dimitri Raptis, 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.

Condition or disease Intervention/treatment
Liver Diseases 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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 90 Days
Official Title: International Study on the Outcomes of Liver Surgery - LiverGroup.Org
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

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)




Primary Outcome Measures :
  1. Mortality rate [ Time Frame: From operation until 90 days postoperatively ]
    Death


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any adult patient undergoing liver surgery.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768141


Contacts
Layout table for location contacts
Contact: Dimitri A Raptis, MD, MSc, PhD +447584560889 dimitri.raptis@nhs.net
Contact: Massimo Malagò, MD, PhD +442077940500 massimo.malago@nhs.net

Locations
Layout table for location information
Spain
University of Zaragoza, Spain Not yet recruiting
Zaragoza, Spain, 50009
Contact: Alejandro Serrablo, MD, PhD    +34976765501    aserrabl@unizar.es   
United Kingdom
Royal Free Hospital Recruiting
London, United Kingdom, NW3 2QG
Contact: Massimo Malagò, MD, PhD         
Contact: Dimitri A Raptis, MD, MSc, PhD    +447584560889    dimitri.raptis@nhs.net   
Sponsors and Collaborators
Royal Free Hospital NHS Foundation Trust
Hospital Universitario Miguel Servet
Investigators
Layout table for investigator information
Principal Investigator: Massimo Malagò, MD, PhD Royal Free Hospital, London, UK
  Study Documents (Full-Text)

Documents provided by Dimitri Raptis, Royal Free Hospital NHS Foundation Trust:

Additional Information:
Layout table for additonal information
Responsible Party: Dimitri Raptis, Senior Clinical Fellow, Royal Free Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03768141     History of Changes
Other Study ID Numbers: v.1.3.2011.11.30
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: https://livergroup.org/?q=protocol_full_version

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dimitri Raptis, Royal Free Hospital NHS Foundation Trust:
Liver
Surgery
Outcomes
Snapshot
Collaborative
International

Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Digestive System Diseases
Liver Extracts
Hematinics