Comparing total pancreatectomy and pancreatic anastomosis for high-risk patients
Total Pancreatectomy or High-risk Pancreatic Anastomosis After Pancreatoduodenectomy (TETRIS): a Randomized Controlled Trial
This study is testing whether total pancreatectomy or pancreatic anastomosis is better for extremely high-risk patients to avoid complications after surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliera Universitaria Integrata Verona Academic / other |
| Locations | 5 sites (Heidelberg and 4 other locations) |
| Trial ID | NCT05212350 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the outcomes of total pancreatectomy versus primary pancreatic anastomosis in patients identified as extremely high-risk for postoperative pancreatic fistula after pancreatoduodenectomy. Eligible patients will be randomized to receive one of the two surgical interventions based on specific intraoperative criteria assessed by multiple surgeons. The study will collect preoperative, intraoperative, and postoperative data to analyze the impact on surgical morbidity and quality of life. The goal is to determine which approach yields better postoperative outcomes for this vulnerable patient population.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for pancreatoduodenectomy with specific high-risk criteria for pancreatic fistula.
Not a fit: Patients who do not meet the eligibility criteria or have a main pancreatic duct diameter greater than 3mm will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients undergoing pancreatic surgery.
How similar studies have performed: While there have been studies on pancreatic surgery outcomes, this specific comparison of total pancreatectomy versus pancreatic anastomosis in high-risk patients is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Heidelberg and 4 other locations
- Department of General, Visceral and Transplantation Surgery, Heidelberg University Hospital — Heidelberg, Germany (Not_yet_recruiting)
- Department of General, Visceral, and Transplant Surgery, Ludwig-Maximilians-University Munich — Munich, Germany (Not_yet_recruiting)
- Department of Surgery, Klinikum rechts der Isar, School of Medicine, Technical University of Munich — Munich, Germany (Not_yet_recruiting)
- Department of General and Pancreatic Surgery, The Pancreas Institute, University of Verona (Main Center) — Verona, Veneto/Verona, Italy (Recruiting)
- Pancreatic Surgery Unit, IRCCS Humanitas Research Hospital — Milan, Italy (Not_yet_recruiting)
Study contacts
- Principal investigator: Roberto Salvia, MD, PhD — Azienda Ospedaliera Universitaria Integrata di Verona
- Study coordinator: Giovanni Marchegiani, MD, PhD
- Email: giovanni.marchegiani@aovr.veneto.it
- Phone: + 39 0458126516
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.