International Liver Surgery Outcomes Study

Liver Diseases Clinical Trial

— LiverGroup  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03768141
• Other study ID #: v.1.3.2011.11.30
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: November 2020
• Source: Royal Free Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Diseases

Intervention

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)

Locations

Country	Name	City	State
Spain	University of Zaragoza, Spain	Zaragoza
United Kingdom	Royal Free Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
Royal Free Hospital NHS Foundation Trust	Hospital Universitario Miguel Servet

Countries where clinical trial is conducted

Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate	Death	From operation until 90 days postoperatively
Secondary	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
Secondary	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
Secondary	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.
Secondary	Re-hospitalisation rate	Readmission to any hospital	From operation until 90 days postoperatively

External Links

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