Condition category
Surgery
Date applied
03/12/2018
Date assigned
13/02/2019
Last edited
15/02/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The safety of liver surgery has dramatically improved over the last 20 years, however complications and death rates differ among countries and hospitals. LiverGroup.org is a collaborative project of liver surgeons worldwide to study the complications and death rates of patients after liver surgery. LiverGroup.org is conducting a worldwide clinical audit that seeks to assess the complication and death rates of patients undergoing liver surgery. Clinical audit is a way to find out if healthcare is being provided in line with standards and lets care providers and patients know where there could be improvements. This type of audit is called a "snapshot" clinical audit as it will record data during a short period of time. The aim is to allow quality improvement to take place where it will be most helpful and will improve outcomes (i.e. complication and death rates) for patients.

Who can participate?
Adult patients (18 years or older) undergoing liver surgery

What does the study involve?
Liver surgeons will enter information in a password-protected and encrypted electronic database. The information will be anonymous data of patients undergoing liver surgery over a 3-month period worldwide.

What are the possible benefits and risks of participating?
There will be no direct health benefit for participants (including no reimbursement of gifts or money) but participation is very likely to help us improve the practice of liver surgery and hence future generations are likely to benefit from it. There are no risks of participating in the study, because there are no changes to treatment as a results of participation.

Where is the study run from?
University of Zaragoza (Spain) and University College London (UK)

When is the study starting and how long is it expected to run for?
December 2015 to March 2020.

Who is funding the study?
University of Zaragoza (Spain) and University College London (UK)

Who is the main contact?
Dr Dimitri Raptis, dimitri.raptis@nhs.net

Trial website

https://livergroup.org/

Contact information

Type

Scientific

Primary contact

Dr Dimitri Raptis

ORCID ID

http://orcid.org/0000-0002-0898-3270

Contact details

Pond Street
London
NW3 2QG
United Kingdom
+447584560889
dimitri.raptis@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

TBC

Protocol/serial number

v.1.3

Study information

Scientific title

International Snapshot Study on the Outcomes of Liver surgery - LiverGroup.org

Acronym

LiverGroup.org

Study hypothesis

The International Liver Surgery Outcomes Study – LiverGroup.org aims 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.

Ethics approval

This project is considered as an audit and does not require ethics committee approval in the UK.

Study design

Observational snapshot study

Primary study design

Observational

Secondary study design

Epidemiological study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Any indication for liver surgery

Intervention

The intervention includes any type of liver surgery. The patients's progress will be observed from the day of the operation until hospital discharge as well as up to 90 days postoperatively.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Death recorded up to 90 days postoperatively using the patients' medical records

Secondary outcome measures

1. Postoperative complications as measured by the Clavien-Dindo Classification, FABIB Liver-Specific Classification and the Comprehensive Complication Index® (CCI®)
2. Liver failure as measured by the FABIB Liver-Specific Classification, the ISGLS criteria and the 50-50 criteria up to 90 days postoperatively
3. Length of hospital stay (defined as the duration of hospitalization from the day of the operation until the day of discharge from the hospital) recorded up to 90 days postoperatively using the patients' medical records
4. Rehospitalization (defined as any readmission to any hospital within 90 days from the operation) assessed using the patients' medical records up to 90 days postoperatively using the patients' medical records

Overall trial start date

12/12/2015

Overall trial end date

10/03/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. All liver surgery indications (including benign and living donor resections, open, laparoscopic or robotic surgery, 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)
2. Any co-morbidity

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2000

Participant exclusion criteria

1. Liver transplantation
2. Imaging-guided RFA, MWA, or other ablation techniques
3. Liver biopsies

Recruitment start date

01/01/2019

Recruitment end date

31/12/2019

Locations

Countries of recruitment

Afghanistan, Aland Islands, Albania, Algeria, American Samoa, Andorra, Angola, Anguilla, Antarctica, Antigua and Barbuda, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Belize, Benin, Bermuda, Bhutan, Bolivia, Bonaire Saint Eustatius and Saba, Bosnia and Herzegovina, Botswana, Bouvet Island, Brazil, British Indian Ocean Territory, Brunei, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Canada, Cape Verde, Cayman Islands, Central African Republic, Chad, Chile, China, Christmas Island, Cocos (Keeling) Islands, Colombia, Comoros, Congo, Congo, Democratic Republic, Cook Islands, Costa Rica, Cote d'Ivoire, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Denmark, Djibouti, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Eritrea, Estonia, Ethiopia, Falkland Islands, Faroe Islands, Fiji, Finland, France, French Guiana, French Polynesia, French Southern Territories, Gabon, Gambia, Georgia, Germany, Ghana, Gibraltar, Greece, Greenland, Grenada, Guadeloupe, Guam, Guatemala, Guernsey, Guinea, Guinea-Bissau, Guyana, Haiti, Heard Island and Mcdonald Islands, Holy See (Vatican City State), Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Isle of Man, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Kiribati, Korea, North, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon, Lesotho, Liberia, Libya, Liechtenstein, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malawi, Malaysia, Maldives, Mali, Malta, Marshall Islands, Martinique, Mauritania, Mauritius, Mayotte, Mexico, Micronesia, Federated States of, Moldova, Monaco, Mongolia, Montenegro, Montserrat, Morocco, Mozambique, Myanmar, Namibia, Nauru, Nepal, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Niger, Nigeria, Niue, Norfolk Island, Northern Mariana Islands, Norway, Oman, Pakistan, Palau, Palestinian Territory, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Pitcairn, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saint Barthelemy, Saint Helena, Saint Kitts and Nevis, Saint Lucia, Saint Martin (French part), Saint Pierre and Miquelon, Saint Vincent and the Grenadines, Samoa, San Marino, Sao Tome and Principe, Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Sint Maarten (Dutch part), Slovakia, Slovenia, Solomon Islands, Somalia, South Africa, South Georgia and the South Sandwich Is, South Sudan, Spain, Sri Lanka, Sudan, Suriname, Svalbard and Jan Mayen, Swaziland, Sweden, Switzerland, Syria, Taiwan, Tajikistan, Tanzania, Thailand, Timor-Leste, Togo, Tokelau, Tonga, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Turks and Caicos Islands, Tuvalu, Uganda, Ukraine, United Arab Emirates, United Kingdom, United States Minor Outlying Islands, United States of America, Uruguay, Uzbekistan, Vanuatu, Venezuela, Viet Nam, Virgin Islands, British, Virgin Islands, U.S., Wallis and Futuna, Western Sahara, Yemen, Zambia, Zimbabwe

Trial participating centre

Royal Free London NHS Foundation Trust, UCL Partners
Pond Street
London
NW3 2QG
United Kingdom

Trial participating centre

University Hospital Miguel Servet
Department of Surgery University Hospital Miguel Servet University of Zaragoza Calle Gonzalo Calamita
Zaragoza
50009
Spain

Sponsor information

Organisation

Royal Free London NHS Foundation Trust, UCL Partners

Sponsor details

Pond Street
London
NW3 2QG
United Kingdom
+442077940500
dimitri.raptis@nhs.net

Sponsor type

Hospital/treatment centre

Website

https://www.royalfree.nhs.uk

Organisation

Department of Surgery, University Hospital Miguel Servet, University of Zaragoza, Spain

Sponsor details

Calle Gonzalo Calamita
Zaragoza
50009
Spain
+34976765501
almaley@telefonica.net

Sponsor type

Hospital/treatment centre

Website

http://sectorzaragozados.salud.aragon.es

Funders

Funder type

Hospital/treatment centre

Funder name

Royal Free Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Universidad de Zaragoza

Alternative name(s)

University of Zaragoza

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Spain

Results and Publications

Publication and dissemination plan

LiverGroup.org is a collaboration of all surgeons contributing data as equal partners. Each surgeon contributing data has access to analysis files of the entire database at any time point and the right to propose analyses and publish data as long as every surgeon contributing data are included as a group author in every publication and have an opportunity to review the data prior to submission. Each collaborator has access to their own data in a form of an Excel export file without requiring permission or approval by the LiverGroup.org management committee.

One single analysis without hierarchical authorship (no first author, no last author) is planned at the end of the study (a “pure” group author publication) to reflect the collaborative effort. Any member of the group is encouraged to step forward with secondary analyses on specific questions and will have full access to the data. There will be no need for approval of publication of data from The LiverGroup.org collaboration, but all group authors have the right to review the manuscripts and have to be given at least 1 week to be able to review the manuscripts.

IPD sharing statement:
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.
The members of LiverGroup.org that have already actively participated in the study and have contributed with cases may contact the Management Committee of LiverGroup.org using the online form (available at: https://livergroup.org/?q=contact) or by email (office@livergroup.org) with their request of the raw data for additional analyses.
All data provided in the form of an Excel database will by fully anonymized without any patient identifiers.

Intention to publish date

01/06/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/02/2019: The participant information sheet has been uploaded.