International Pancreatic Surgery Outcomes Study - PancreasGroup.Org
PancreasGroup.Org - International Pancreatic Surgery Outcomes Study
1 other identifier
observational
3,500
0 countries
N/A
Brief Summary
"Snapshot" study worldwide over 3 months in 2021. Provide a verified record of true morbidity and mortality. Identify modifiable predicting factors of outcome. Obtain PubMed citable co-authorship,
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2020
CompletedFirst Posted
Study publicly available on registry
December 3, 2020
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedSeptember 16, 2021
September 1, 2021
7 months
November 26, 2020
September 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality
Postoperative death
90 days postoperatively
Secondary Outcomes (1)
Morbidity
90 days postoperatively
Study Arms (1)
Patients undergoing pancreatic surgery
Patients undergoing any type of pancreatic surgery.
Interventions
Open, laparoscopic or robotic surgery of the pancreas
Eligibility Criteria
All adult patients undergoing pancreatic resection by surgeons at their respective centres are eligible for study inclusion.
You may qualify if:
- All indications (including benign and malignant)
- Open, laparoscopic or robotic.
- Elective or emergency.
- Partial or total pancreatectomies.
- Pancreatic tumour enucleations.
- Procedures with concomitant vascular or other organ resections.
- Pancreatic duct drainage procedures (e.g. Frey, Puestow, or Beger)
- Adults 18 years of age or older.
You may not qualify if:
- Pancreas or islet cell transplantation.
- Transcutaneous or transgastric imaging-guided ablation (e.g. RFA) or electroporation (e.g. NanoKnife).
- Endoscopic (e.g. endoscopic retrograde cholangiopancreatography, stent or lithotripsy) procedures.
- Endoscopic transgastric and surgical necrosectomies excluded.
- Patients less than 18 years of age excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royal Free Hospital NHS Foundation Trustlead
- University College London Hospitalscollaborator
- Massachusetts General Hospitalcollaborator
Related Publications (1)
PancreasGroup.org Collaborative. Pancreatic surgery outcomes: multicentre prospective snapshot study in 67 countries. Br J Surg. 2024 Jan 3;111(1):znad330. doi: 10.1093/bjs/znad330.
PMID: 38743040DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Guiseppe K Fusai, MD, MS
Royal Free Hospital London, UK
- STUDY CHAIR
Cristina Ferrone, MD
Massachusetts General Hospital, Boston, USA
- PRINCIPAL INVESTIGATOR
Dimitri A Raptis, MD, MSc, PhD
Royal Free Hospital London, UK
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2020
First Posted
December 3, 2020
Study Start
September 1, 2021
Primary Completion
March 31, 2022
Study Completion
March 31, 2022
Last Updated
September 16, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- The data will become available after the first and main publication of PancreasGroup.org. They will be available for at least 10 years.
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 excel export file without requiring permission or approval by the PancreasGroup.org management committee.