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Search / Trial NCT05212350

Total pancrEaTectomy vs High-Risk Pancreatic anastomosiS

Launched by AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA · Jan 24, 2022

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Pancreatic Fistula High Risk Pancreas Pancreatoduodenectomy Pancreatic Anastomosis Total Pancreatectomy

ClinConnect Summary

This clinical trial is studying two different surgical methods for patients with serious pancreatic conditions. It compares total pancreatectomy, where the entire pancreas is removed, to a procedure called primary pancreatic anastomosis, which connects the pancreas back to the digestive system. The main goal is to see which method leads to better recovery outcomes and quality of life after surgery, especially for patients who are considered at high risk for complications like pancreatic fistula, a condition where the pancreas leaks digestive juices into the abdomen.

To participate in the trial, you need to be at least 18 years old and scheduled for a specific type of surgery called pancreatoduodenectomy, which is done for various pancreatic diseases. You also need to meet certain medical criteria that indicate you are at high risk for complications. If you decide to join, you can expect to receive one of the two surgical procedures and will be monitored closely afterward to assess your recovery and overall well-being. It's important to know that the trial is currently recruiting participants, and your involvement could help improve surgical outcomes for future patients facing similar challenges.

Gender

ALL

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

About Azienda Ospedaliera Universitaria Integrata Verona

Azienda Ospedaliera Universitaria Integrata Verona is a leading academic hospital institution in Italy, dedicated to advancing healthcare through innovative clinical research and patient care. With a strong emphasis on collaboration between its medical staff and academic partners, the institution integrates comprehensive clinical services with cutting-edge research initiatives. This multidisciplinary approach ensures the delivery of high-quality healthcare while contributing to the development of new medical knowledge and therapies. The organization is committed to improving patient outcomes and fostering evidence-based practices in the medical community.

Locations

Munich, , Germany

Heidelberg, , Germany

Munich, , Germany

Verona, Veneto/Verona, Italy

Milan, , Italy

Verona, , Italy

Patients applied

0 patients applied

Trial Officials

Roberto Salvia, MD, PhD

Principal Investigator

Azienda Ospedaliera Universitaria Integrata di Verona

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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