An international study to investigate rates of death and illness following liver surgery

ISRCTN	ISRCTN14071325
DOI	https://doi.org/10.1186/ISRCTN14071325
ClinicalTrials.gov (NCT)	NCT03768141
Protocol serial number	v.1.3
Sponsors	Royal Free London NHS Foundation Trust, Department of Surgery, University Hospital Miguel Servet, University of Zaragoza, Spain
Funders	Royal Free Hospital, Universidad de Zaragoza

Submission date: 03/12/2018
Registration date: 13/02/2019
Last edited: 06/03/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Dimitri Raptis
Scientific

Pond Street
London
NW3 2QG
United Kingdom

ORCID ID	0000-0002-0898-3270
Phone	+447584560889
Email	dimitri.raptis@nhs.net

Study information

Primary study design	Observational
Study design	Observational snapshot study
Secondary study design	Epidemiological study
Participant information sheet	ISRCTN14071325_PIS_v4.pdf
Scientific title	International Snapshot Study on the Outcomes of Liver surgery - LiverGroup.org
Study acronym	LiverGroup.org
Study objectives	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(s)	This project is considered as an audit and does not require ethics committee approval in the UK.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Death recorded up to 90 days postoperatively using the patients' medical records
Key secondary outcome measure(s)	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
Completion date	10/03/2020

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	2000
Key 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
Key exclusion criteria	1. Liver transplantation 2. Imaging-guided RFA, MWA, or other ablation techniques 3. Liver biopsies
Date of first enrolment	01/01/2019
Date of final enrolment	31/12/2019

Locations

Countries of recruitment

United Kingdom
England
Afghanistan
Åland 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 Darussalam
Bulgaria
Burkina Faso
Burundi
Cabo Verde
Cambodia
Cameroon
Canada
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos (Keeling) Islands
Colombia
Comoros
Congo
Congo, Democratic Republic
Cook Islands
Costa Rica
Croatia
Cuba
Curaçao
Cyprus
Czech Republic
Côte d'Ivoire
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Eswatini
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
Lao People's Democratic Republic
Latvia
Lebanon
Lesotho
Liberia
Libya
Liechtenstein
Lithuania
Luxembourg
Macao
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
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
North Macedonia
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestine, State of
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn
Poland
Portugal
Puerto Rico
Qatar
Romania
Russian Federation
Rwanda
Réunion
Saint Barthélemy
Saint Helena, Ascension and Tristan da Cunha
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 Islands
South Sudan
Spain
Sri Lanka
Sudan
Suriname
Svalbard and Jan Mayen
Sweden
Switzerland
Syria
Taiwan
Tajikistan
Tanzania
Thailand
Timor-Leste
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkmenistan
Turks and Caicos Islands
Tuvalu
Türkiye
Uganda
Ukraine
United Arab Emirates
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

Study participating centres

Royal Free London NHS Foundation Trust, UCL Partners

Pond Street
London
NW3 2QG
United Kingdom

University Hospital Miguel Servet

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

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/12/2023	06/03/2024	Yes	No
Participant information sheet	version v4		13/02/2019	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN14071325_PIS_v4.pdf: Uploaded 13/02/2019

Editorial Notes

06/03/2024: Publication reference added.
23/05/2019: ClinicalTrials.gov number added.
13/02/2019: The participant information sheet has been uploaded.