Total pancrEaTectomy vs High-Risk Pancreatic anastomosiS (TETRIS)
Pancreatic Fistula
About this trial
This is an interventional prevention trial for Pancreatic Fistula focused on measuring Pancreatic fistula, High-risk pancreas, Pancreatoduodenectomy, Pancreatic anastomosis, Total pancreatectomy
Eligibility Criteria
Inclusion Criteria:
- Patients older than 18 years
- All patients scheduled for PD for all kind of pancreatic diseases
- Patients able to give their informed consent
- Patients undergoing PD (Kausch-Whipple or Longmire-Traverso)
- Patients presenting two major and at least one minor criteria (Major criteria: Main pancreatic duct diameter ≤3mm; Soft pancreas. Minor criteria: Bleeding stump; Friable stump; Posterior/Eccentric duct; Invisible duct; Deep pancreas; Intraoperative acute pancreatitis; FRS 9-10)
- Two or more surgeons confirming eligibility
- PA or TP with or without spleen preservation (Kimura technique). These techniques are consistent with clinical practice; any other procedure will be a deviation from the protocol
Exclusion Criteria:
- Informed consent withdrawal
- Impossibility to undergo surgery for any reason
- Main pancreatic duct of the pancreatic neck/body >3mm at preoperative imaging (CT scan or MRI)
- PD not performed for any reason
- Absence of two major criteria
- Absence of at least one minor criteria
- Absence of interobserver agreement between at least 2 surgeons
- More than 1 extension of resection to pancreatic neck due to pancreatic margin positivity
- Wrong randomization
Sites / Locations
- Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital
- Department of General, Visceral, and Transplant Surgery, Ludwig-Maximilians-University Munich
- Department of Surgery, Klinikum rechts der Isar, School of Medicine, Technical University of Munich
- Department of General and Pancreatic Surgery, The Pancreas Institute, University of Verona (Main Center)Recruiting
- Pancreatic Surgery Unit, IRCCS Humanitas Research Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Pancreatic anastomosis
Total pancreatectomy
Pancreatic anastomosis (PA) will be carried out according to the techniques adopted by the participating Centre, either pancreaticojejunostomy (PJ) (i.e. dunking PJ, Cattel-Warren duct-to-mucosa PJ, Blumgart PJ) or pancreatico-gastrostomy (PG) will be considered eligible. Any mitigation strategy (i.e. ETS, use of glues/biological matrices to protect the anastomosis, surgical feeding jejunostomy, prophylactic hydrocortisone/somatostatin administration) can be used according to the Center practice. The other two anastomosis, hepaticojejunostomy and duodenojejunostomy (in case of Longmire-Traverso pancreatoduodenectomy) or gastrojejunostomy (in case of Kausch-Whipple pancreatoduodenectomy), will be carried out as usual according to each Institution's operative standards. At least one surgical drain will be placed in the retroperitoneum in all patients.
Total pancreatectomy will be carried out according to each Institution's operative standards. Preservation of the spleen will be considered whenever possible according to Kimura technique. Either ligation or preservation of gastric vessels (right/left gastric artery/vein) will be allowed according to clinical necessity but will be recorded and correlated with postoperative outcomes. The reconstruction phase will be carried out according to each Institution's operative standards. One or more surgical drains can be left in place according to surgeon's preference.