Ductaal adenocarcinoom van het pancreas Pancreatic adenocarcinoma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age equal or above 18 years; Indication for elective distal pancreatectomy for expected PDAC; Upfront (without induction / down-sizing radio- or chemotherapy) resectable PDAC in the pancreatic body or tail; The tumour can be radically resected via both minimally invasive or open surgery according to the local treating team; The patient is fit to undergo distal pancreatectomy, either minimally invasive or open
Exclusion criteria
Exclusion criteria: ASA-score >3 History of chronic pancreatitis Surgery for secondary tumour Distant metastases (M1) Tumour involvement of major vessels Pregnancy Participation in study with interference of study outcomes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is microscopically radical resection margins (R0) (these can be in the transection margin of the pancreas but also in the anterior, superior, posterior, inferior margins, i.e. circumferential margins). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary endpoints are: - Intraoperative parameters (operative time, blood loss, blood transfusion and conversion) - Postoperative parameters (complications, mortality, re-interventions) - Pathology parameters (tumor size, lymph node retrieval, positive nodes, invasion, grading and staging) - Hospitalization parameters (time to functional recovery, tot hospital sta, readmission, intensive care admission) - Oncology parameters (use of (neo-)adjuvant chemotherapy - Quality of life - Costs | — |
Countries
Netherlands