OBJECTIVE
To conduct a retrospective multicenter cohort study to define benchmark values for best achievable outcomes following total pancreatectomy (TP).
POLICY SECURING
Confidential center specific data: No center-specific data will be published. Instead, all complications or adverse outcomes will be anonymously reported, as fractions of the total study population. Each center, of course, will be free to publish their own data, as they wish.
Authorship: No data will be submitted or published without authorization from each participating center. Each center will be represented by its contributors including two co-authorships per center. If >60 patients are enrolled, 3 authors authorships will be attributed. If >120 patients are enrolled, 4 authors authorships will be attributed.
In the ideal case there will be one junior author who will coordinate data collection with PD Dr. Philip Müller (Study coordinator of the study from Basel).
Further use of cohort data: Future studies based on the collected data will hopefully emerge from this multicenter study.
METHODS
Benchmark Values:
- Mortality
- Morbidity
- Complication grading according to Clavien-Dindo (Dindo et al., Ann Surg, 2004)
- Complication quantification with the CCI (Slankamenac et al., Ann Surg, 2013)
- Pancreas specific complications (DGE, PPH)
- Diabetes-related hypoglycemia
- Operation characteristics
- Duration of surgery
- Blood loss
- R0 resection
- Number of harvested lymph nodes
- Length of stay (ICU), length of stay (hospital)
- Readmission
- Disease free survival (DFS) and Overall survival (OS) (reported at one and 3 years)
Study period:
- 01/2017 – 12/2023
Center eligibility:
- >50 annual pancreatic procedures per center
- Prospective database available
Patient eligibility (benchmark cases criteria):
Please note that, at this stage, the study will include all consecutive TP cases (benchmark and non-benchmark cases).
Inclusion criteria:
- Adults ≥ 18 years
- TP (any indication)
GOVERNANCE
Data will be collected via a secure; password protected, and encrypted online data management system, provided by the University Hospital of Basel. This platform uses a data entry management system (DEMS) to meet international standards for online databases including fully anonymous data. Data will not be published with hospital identifiers.
DATA COLLECTION
Local collaborators: Most hospitals will have two local investigators; a senior and a junior investigator. The junior collaborator will be in regular contact with the study coordinators in Basel (Dr. Philip Müller). The junior investigator will be responsible for:
- Gaining local research ethics approval
- Identifying and including all eligible patients
- Accurately collect baseline and follow-up data
- Submit data to the online DEMS database