Condition category
Surgery
Date applied
25/11/2020
Date assigned
03/12/2020
Last edited
03/12/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

https://pancreasgroup.org/

Contact information

Type

Scientific

Primary contact

Dr Dimitri Aristotle Raptis

ORCID ID

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

Contact details

Royal Free Hospital
Department of HPB Surgery and Liver Transplant
London
NW3 2QG
United Kingdom
+447584560889
dimitri.raptis@nhs.net

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

RFH287_20-21

Study information

Scientific title

International Pancreatic Surgery Outcomes Study - PancreasGroup.org

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

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

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

https://pancreasgroup.org/sites/default/files/Patient_Information_and_Consent_form_PancreasGroup.org_v1.docx

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

Phase

Drug names

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 trial start date

21/09/2019

Overall trial end date

31/03/2022

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

We anticipate over 3,500 cases submitted worldwide. This will allow meaningful comparisons regarding mortality rates.

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, 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 States Minor Outlying Islands, Uruguay, Uzbekistan, Vanuatu, Venezuela, Viet Nam, Virgin Islands, British, Virgin Islands, U.S., Wallis and Futuna, Western Sahara, Yemen, Zambia, Zimbabwe

Trial participating centre

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

Trial participating centre

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

Trial participating centre

Cristina Ferrone
Massachusetts General Hospital
Boston
MA 02114
United States of America

Sponsor information

Organisation

Royal Free London NHS Foundation Trust

Sponsor details

Pond Street
London
NW3 2QG
United Kingdom
+44 (0)2077940500
dimitri.raptis@nhs.net

Sponsor type

Hospital/treatment centre

Website

http://www.royalfree.nhs.uk/

Funders

Funder type

Charity

Funder name

Royal Free Charity - Fiorina Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement:
The datasets generated during and/or analysed during the current study are available from Dr Dimitri Raptis, dimitri.raptis@nhs.net on reasonable request.

Intention to publish date

01/07/2022

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

01/12/2020: Trial’s existence confirmed by Royal Free Hospital Quality Governance Department.