The goal of this clinical trial is to learn if total removal of the pancreas is a preferable alternative to partial removal in patients with cancer of the pancreatic head who are at high risk of pancreatic leakage. The main question it aims to answer is:
Does total pancreas removal improve survival without reducing quality of life compared to partial removal?
The only study specific procedures are the collection of 2 blood samples (7.5ml for each time point, preoperatively and during the hospitalisation) and the completion of the questionnaires.
Adult patients (age ≥ 18 years) scheduled to undergo PD for highly suspected or histologically proven, resectable pancreatic ductal adenocarcinoma (PDAC), distal cholangiocarcinoma (DCC), and/or ampullary cancer (pancreaticobiliary type)
Suspected pancreas anastomosis at high-risk for development of a postoperative pancreatic fistula (POPF) (grade "D" according to Schuh et al. (29): Estimation by CT scan, MRI, and/or Endoscopic Ultrasound
Written informed consent
Duodenal carcinoma, ampullary cancer (intestinal type), neuroendocrine tumors, benign tumors, chronic pancreatitis
Medical conditions that do not allow appreciation of the nature, scope, and possible consequences of the trial as judged by the investigator
Pregnancy. A beta-Human Chorionic Gonadotropin (bHCG) pregnancy test must to be performed for women of child-bearing potential (defined as premenopausal women who have not undergone surgical sterilization)
Inability to follow the study procedures, e.g., due to psychological disorders, dementia, etc.
Parallel
Total pancreatectomy (TP)
Procedure/SurgeryThe investigators perform TP in patients who undergo surgical resection of a malignant tumor in the pancreatic head.
Partial pancreaticoduodenectomy (PD)
Procedure/SurgeryThe investigators perform partial PD with anastomosis of the pancreas in patients who undergo surgical resection of a malignant tumor in the pancreatic head. This is the current standard procedure.
Overall survival (OS)
Number of participants who survived for 2 years after surgery.
Quality of Life (QoL) Pancreatic Cancer
Recorded as participant-reported outcome. Measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for pancreatic cancer (EORCT QLQPAN26). Scale from 0 to 104, with higher scores indicating a greater level of symptoms or problems.
Quality of Life (QoL) Diabetes
Recorded as participant-reported outcome. Measured by Diabetes Distress Scale (DDS) 17 Questionnaire (only for patients with insulin-dependent diabetes). Scale from 17 to 102, with higher scores indicating a greater level of distress.
Postoperative complications (discriminating minor and major complications)
Number of participants with postoperative complications. Classified according to the Clavien-Dindo-classification (major complication defined as Clavien-Dindo Grade ≥ III).
Mortality
Number of participants who died.
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