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

ISRCTN	ISRCTN95140761
DOI	https://doi.org/10.1186/ISRCTN95140761
Secondary identifying numbers	RFH287_20-21

Submission date: 25/11/2020
Registration date: 03/12/2020
Last edited: 20/05/2024

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

Background and study aims
Although death after pancreatic surgery has decreased significantly in specialised high-volume centres, the number of people with pancreatic diseases still remains high. Complexity and extent of pancreatic operations, patient selection, centre and surgeon experience all influence the outcomes following an operation. Furthermore, patients present at an older age and with other diseases which increase the risk of postoperative complications. The aim of PancreasGroup.org is to identify the true world-wide morbidity and mortality of pancreatic operations. The second aim is to identify modifiable predicting factors to improve the outcomes after pancreatic surgery.

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

What does the study involve?
Pancreatic surgeons will enter information in a password-protected and encrypted electronic database. The information will be anonymous data of patients undergoing pancreatic 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 pancreatic 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?
1. Royal Free Hospital, London (UK)
2. Massachusetts General Hospital, Boston (USA)

When is the study starting and how long is it expected to run for?
September 2019 to March 2022

Who is funding the study?
1. Royal Free Hospital, London (UK)
2. Massachusetts General Hospital, Boston (USA)

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

Study website

Contact information

Dr Dimitri Aristotle Raptis
Scientific

Royal Free Hospital
Department of HPB Surgery and Liver Transplant
London
NW3 2QG
United Kingdom

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

Study information

Study design	Observational cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	https://pancreasgroup.org/sites/default/files/Patient_Information_and_Consent_form_PancreasGroup.org_v1.docx
Scientific title	International Pancreatic Surgery Outcomes Study - PancreasGroup.org
Study acronym	PancreasGroup.org
Study hypothesis	The aim of PancreasGroup.org is to identify the true world-wide morbidity and mortality of pancreatic operations. The second aim is to identify modifiable risk factors to improve the outcomes after pancreatic surgery.
Ethics approval(s)	No ethics approval required. Registered and approved as an audit by the Royal Free Hospital Quality Governance Department with the ID number RFH287_20-21
Condition	Patients with pancreatic disease requiring surgery
Intervention	Participants, agreeing to be part of this study, will be observed from the date of surgery until hospital discharge as well as 90 days after their operation. Fully anonymised data will be collected including the participant, their disease, operation characteristics as well as outcomes, such as events including death and illness.
Intervention type	Procedure/Surgery
Primary outcome measure	Mortality rate 90 days postoperatively measured using patient records
Secondary outcome measures	Morbidity as defined by the Clavien-Dindo Classification and measured by the Comprehensive Complications Index ® (CCI®) at 90 days postoperatively measured using patient records
Overall study start date	21/09/2019
Overall study end date	31/03/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	We anticipate over 3,500 cases submitted worldwide. This will allow meaningful comparisons regarding mortality rates.
Total final enrolment	4223
Participant inclusion criteria	1. Adults 18 years of age or older 2. All indications (including benign and malignant) 3. Open, laparoscopic or robotic 4. Elective or emergency 5. Partial or total pancreatectomies 6. Pancreatic tumour enucleations 7. Procedures with concomitant vascular or other organ resections 8. Pancreatic duct drainage procedures (e.g. Frey, Puestow, or Beger)
Participant exclusion criteria	1. Pancreas or islet cell transplantation 2. Transcutaneous or transgastric imaging-guided ablation (e.g. RFA) or electroporation (e.g. NanoKnife) 3. Endoscopic (e.g. ERCP, stent or lithotripsy) procedures 4. Endoscopic transgastric and surgical necrosectomies
Recruitment start date	01/01/2021
Recruitment end date	31/12/2021

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 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 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
Åland Islands

Study participating centres

Guiseppe Kito Fusai

Royal Free Hospital
Department of HPB Surgery and Liver Transplant
Pond Street
London
NW3 2QG
United Kingdom

Dimitri Aristotle Raptis

Royal Free Hospital
Department of HPB Surgery and Liver Transplant
Pond Street
London
NW3 2QG
United Kingdom

Cristina Ferrone

Massachusetts General Hospital
Boston
MA 02114
United States of America

Sponsor information

Royal Free London NHS Foundation Trust
Hospital/treatment centre

Pond Street
London
NW3 2QG
England
United Kingdom

Phone	+44 (0)2077940500
Email	dimitri.raptis@nhs.net
Website	http://www.royalfree.nhs.uk/
"ROR"	https://ror.org/04rtdp853

Funders

Funder type

Charity

Royal Free Charity - Fiorina Fund

No information available

Results and Publications

Intention to publish date	01/07/2022
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	PancreasGroup.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 PancreasGroup.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 PancreasGroup.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 plan	The datasets generated during and/or analysed during the current study are available from Dr Dimitri Raptis, dimitri.raptis@nhs.net on reasonable request.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		03/01/2024	20/05/2024	Yes	No

Editorial Notes

20/05/2024: Publication reference added.
01/12/2020: Trial’s existence confirmed by Royal Free Hospital Quality Governance Department.