Status:
UNKNOWN
Total pancrEaTectomy vs High-Risk Pancreatic anastomosiS
Lead Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
Conditions:
Pancreatic Fistula
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Postoperative pancreatic fistula (POPF) is the main driver of surgical morbidity after pancreatoduodenectomy (PD). The aim of the present study is to compare total pancretectomy (TP) and primary pancr...
Detailed Description
The study will be organized as a multicentric randomized controlled trial. When a patient will be considered eligible preoperatively, he or she will be enrolled in the present study. The patient's ris...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT05212350
Start Date
October 21 2021
End Date
December 1 2025
Last Update
January 28 2022
Active Locations (5)
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1
Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital
Heidelberg, Germany, 69120
2
Department of General, Visceral, and Transplant Surgery, Ludwig-Maximilians-University Munich
Munich, Germany, 81377
3
Department of Surgery, Klinikum rechts der Isar, School of Medicine, Technical University of Munich
Munich, Germany, 81675
4
Department of General and Pancreatic Surgery, The Pancreas Institute, University of Verona (Main Center)
Verona, Veneto/Verona, Italy, 37134