Benign Pancreas Tumor, Malignant Pancreatic Neoplasm
Conditions
Keywords
004516, benign pancreas tumor, malignant pancreatic neoplasm, pancreaticoduodenectomy, distal pancreatectomy, total pancreatectomy, central pancreatectomy, chronic pancreatitis
Brief summary
There is a need for a structured registry to collect real-world data on patient characteristics, surgical strategies, perioperative outcomes, and long-term results. Such a registry will provide insights into quality of care, support benchmarking, and form the basis for clinical and translational research.
Detailed description
The objective of this study is to collect and register all clinical data on patients undergoing pancreatic surgery at Antwerp University Hospital. Data collection will include demographic information, medical history, preoperative workup, surgical details, postoperative outcomes, lab results, pathology results and long-term follow-up. There is no intervention in this study; patient care will be done according to the current standard of care. The data will be used to further improve patient outcomes, identify risk factors for complications (both patient-specific and procedure-specific), investigate oncological outcomes and long-term patient survival, help predict exocrine and endocrine insufficiency, and identify patient populations in which specific screening for this is indicated.
Interventions
None listed
Sponsors
University Hospital, Antwerp
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* benign indications for pancreatic surgery, including chronic pancreatitis, cystic lesions and IPMN * malignant indications for pancreatic surgery, including PDAC, duodenal carcinoma, pancreatic neuro-endocrine tumours, distal cholangiocarcinoma.
Exclusion criteria
* indications for pancreatic resection caused by acute pancreatitis * pancreatic resection after abdominal trauma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 90-day mortality | 25 years | 90-day mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Establishment of a registry for patients undergoing pancreatic surgery - secondary outcome measures | 25 years | * 30-day mortality * morbidity, expressed as specific postpancreatectomy complications ( = defined by the ISPGS (International Study Group for Pancreatic Surgery), i.e. POPF (postoperative pancreatic fistula), chyle leak, PPH (postpancreatectomy haemorrhage), bile leak and delayed gastric emptying), postoperative complications defined by the Clavien Dindo scoring and the CCI (comprehensive complication index) * duration of hospital stay * need for postoperative transfusion * development of exocrine- or endocrine insufficiency (through systematic postoperative function testing) * overall survival * disease free survival |
Countries
Belgium
Outcome results
None listed