International Snapshot Study on the Outcomes of Pancreatic Surgery - PancreasGroup.org
Download the short version of the protocol in different languages (click on the relevant icon above)
Introduction: Although mortality after pancreatic surgery has decreased significantly in specialised high-volume centres, morbidity still remains high. Complexity and extent of pancreatic operations, patient selection, centre and surgeon experience all influence postoperative outcomes. Furthermore, patients present at an older age and with more comorbidities 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 risk factors to improve the outcomes after pancreatic surgery.
Eligibility: Any surgeon worldwide performing pancreatic surgery is eligible to participate in PancreasGroup.org. There are no minimum number of cases to be submitted or selection criteria for centres.
Time period and team members: Each participant may form a team of 3 members in total and each centre may have more than one team. There will be 3 months of prospective patient enrolment and 3 months follow up within a 12-month frame (Jan – Dec 2021) (Figure).
Inclusion criteria: All types of pancreatic surgery will be included:
- 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.
- Pancreas or islet cell transplantation.
- Transcutaneous or transgastric imaging-guided ablation (e.g. RFA) or electroporation (e.g. NanoKnife).
- Endoscopic (e.g. ERCP, stent or lithotripsy) procedures.
- Endoscopic transgastric and surgical necrosectomies excluded.
- Patients less than 18 years of age excluded.
Outcomes: the primary endpoint of the analysis will be 90-day mortality. Secondary endpoints will be the 90-day postoperative rates of pancreatic fistula, endocrine or exocrine insufficiency, type and Clavien-Dindo grade of complications, length of stay, hospital readmission rates, and R1/R2 resections.
Data ownership: The headquarters at the Royal Free Hospital in London, UK will act as the custodian of the data. The Scientific 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. All participants will be able to download their own submitted data in excel format without any need for permission from the study sponsor.
Authorship: A single analysis and reporting 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, in keeping with other global snapshot studies. All collaborators will be PubMed cited in the main publication as well as in any future studies. Spin-off studies may include formal authorship but must include the “PancreasGroup.org Collaborative” citing all participants.