International living donor liver transplant registry – LDLTregistry.org

ISRCTN	ISRCTN84544531
DOI	https://doi.org/10.1186/ISRCTN84544531
Secondary identifying numbers	AO_2023-00013

Submission date: 06/02/2023
Registration date: 30/05/2023
Last edited: 31/05/2023

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
Living donor liver transplantation (LDLT) was introduced in the early 1990s to overcome an increasing shortage of available deceased donor organs for transplantation. LDLT remains the main source of grafts for liver transplantation in Asian countries. However, reports on donor illness and even death have hampered the uptake of the procedure in Western countries. Outcome data are available from developed countries, but outcomes in developing countries remain unknown. There is a need to collect data from all parts of the world to create a single prospective registry and allow meaningful comparisons, as well as standardization of the procedure, across the globe.

Who can participate?
Any center worldwide involved in LDLT is eligible to participate in this registry. There are no minimum number of cases to be submitted or selection criteria for centers. Cases must be prospectively registered. Both donors and recipients will be included in the registry, including adult and pediatric, two-stage LDLT, as well as dual grafts. Domino grafts will be excluded.

What does the study involve?
The researchers have developed a worldwide registry that seeks to assess the complication rates of donors and recipients undergoing living donor liver transplantation. Audits and registries are a way to find out if healthcare is being provided in line with standards and allow care providers and patients to envision potential improvements. Healthcare providers across the world submit anonymized case details of patients undergoing living donor liver transplantation. This acts as a central database until the end of the trial period when primary analysis will take place.

What are the possible benefits and risks of participating?
There will be no direct health benefit for the participants but their participation is very likely to help to improve the practice of living donor liver transplantation and hence future generations are likely to benefit from it. There are no risks of participating.

Where is the study run from?
Klinik Hirslanden (Switzerland)

When is the study starting and how long is it expected to run for?
April 2023 to September 2033

Who is funding the study?
1. Rela Institute (India)
2. International Liver Transplant Society (ILTS)
3. International Living Donor Liver Transplantation (iLDLT) Group

Who is the main contact?
Dr Dimitri Raptis, dimitri.raptis@gmail.com

Study website

Contact information

Prof Mohamed Rela
Principal Investigator

#7, CLC Works Road
Chromepet
Chennai
600 044
India

ORCID ID	0000-0003-4282-4676
Phone	+91 (0)9384681770
Email	mohamed.rela@gmail.com

Dr Dimitri Raptis
Scientific

Pond Street
London
NW3 2QG
United Kingdom

ORCID ID	0000-0002-0898-3270
Phone	+44 (0)7584560889
Email	dimitri.raptis@gmail.com

Study information

Study design	Observational cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital, Medical and other records
Study type	Treatment
Participant information sheet	43172_PIS_v1.pdf
Scientific title	International living donor liver transplant registry
Study acronym	LDLTregistry.org
Study hypothesis	Living donor liver transplantation (LDLT) was introduced in the early 1990s to overcome an increasing shortage of available deceased donor organs for transplantation. LDLT remains the main source of grafts for liver transplantation in Asian countries, however, reports on donor morbidity and even mortality have hampered the uptake of the procedure in Western countries. Outcome data are available from developed countries, but outcomes in developing countries remain unknown. There is a need to collect data from all parts of the world, to create a single prospective registry and allow meaningful comparisons, as well as standardization of the procedure, across the globe.
Ethics approval(s)	Approved 17/04/2023, Kantonale Ethikkomission Zürich (Klinik Hirslanden Zürich vivévis AG PD Dr. med. univ. Christian Oberkofler, Kappelistrasse 7 8002, Zürich, Switzerland; +41 (0)43 259 79 70; admin.kek@kek.zh.ch), ref: AO_2023-00013
Condition	Living donor liver transplantation
Intervention	A global prospective registry of perioperative morbidity and mortality post-LDLT will be established to collect data for donors and recipients. All clinicians involved in LDLT are eligible to submit data to the registry. Data will be collected until hospital discharge and up to 90 days postoperatively. The primary endpoint of the analysis is 90-day morbidity and mortality for both recipients and donors. Secondary endpoints include the identification of modifiable predictors of outcome. Additional outcome data will be captured and analysed after 12 months of follow-up.
Intervention type	Other
Primary outcome measure	Morbidity and mortality for both the donor and recipient until hospital discharge and up to 90 days postoperatively, collected from patients' medical records, operation reports and information from electronic patient records
Secondary outcome measures	Identification of modifiable predictors of outcome at 90 days post-operation, collected from patients' medical records, operation reports and information from electronic patient records. Additional outcome data will be captured at 12 months follow up
Overall study start date	01/04/2023
Overall study end date	01/09/2033

Eligibility

Participant type(s)	Mixed
Age group	Mixed
Sex	Both
Target number of participants	2000
Participant inclusion criteria	1. Cases must be prospectively registered 2. Both donors and recipients will be included in the registry, including adult and pediatric, two-stage LDLT (e.g. Auxiliary, RAPID, APOLT, ASPIRE, RAVAS), as well as dual grafts RAPID = Resection And Partial lIver segment 2–3 transplantation with Delayed total hepatectomy APOLT = Auxiliary Partial Orthotopic Living Donor Liver Transplantation ASPIRE = Auxiliary two-Staged PartIal REsection liver transplantation RAVAS = Heterotopic transplantation of segments 2 and 3 using the splenic vein and artery after splenectomy and with delayed total hepatectomy
Participant exclusion criteria	Domino grafts
Recruitment start date	01/09/2023
Recruitment end date	01/09/2027

Locations

Countries of recruitment

Afghanistan
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
England
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 Ireland
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
Scotland
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 Kingdom
United States Minor Outlying Islands
United States of America
Uruguay
Uzbekistan
Vanuatu
Venezuela
Viet Nam
Virgin Islands, British
Virgin Islands, U.S.
Wales
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe
Åland Islands

Study participating centre

Hirslanden Zürich

Witellikerstrasse 40
Zürich
CH-8032
Switzerland

Sponsor information

Klinik Hirslanden
Hospital/treatment centre

Witellikerstrasse 40
Zürich
CH-8032
Switzerland

Phone	+41 (0)44 387 21 11
Email	christian.oberkofler@vivevis.ch
"ROR"	https://ror.org/014c2qb55

Funders

Funder type

Research organisation

Rela Institute

No information available

International Liver Transplant Society (ILTS)

No information available

International Living Donor Liver Transplantation (iLDLT) Group

No information available

Results and Publications

Intention to publish date	01/09/2024
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	All LDLTregistry.org members, with submitted verified cases to the registry, will be PubMed cited as group authors in the main publications. Spin-off studies may include formal named authorship but must include the “LDLTregistry.org Collaborative” with group authorship for all participants.
IPD sharing plan	LDLTregistry.org will act as the custodian of the data. All participants will be able to access their own submitted data without the need for permission from the LDLTregistry.org Committees. The Chief Investigators, Scientific and Management committees together will decide about data sharing requests and will consider all such requests based on the quality and validity of the proposed project. The datasets generated during and/or analysed during the current study are/will be available upon request from Dimitri Raptis (dimitri.raptis@gmail.com)/ All data-sharing requests are to be considered on a case-by-case basis. Participating centers have the responsibility to request ethics approval for their respective recruiting centers and obtain written informed consent as per the legislation of the countries of the recruiting and participating centers. All data is anonymised such that individual patient identifying information is anonymised and details regarding individual operating clinicians are also anonymised.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version 1		30/05/2023	No	Yes
Protocol file	version 7		31/05/2023	No	No

Additional files

43172_PIS_v1.pdf
ISRCTN84544531_PROTOCOL_v7.pdf

Editorial Notes

31/05/2023: The following changes were made to the study record:
1. Protocol uploaded.
2. Contact details added.
3. Hirslanden Zürich was added to the study participating centres and University College London Hospitals NHS Foundation Trust was removed.
4. The sponsor was changed from University College London to Klinik Hirslanden.
4. The overall study end date was changed from 01/09/2027 to 01/09/2033.
15/05/2023: Study's existence confirmed by the Kantonale Ethikkomission Zürich.