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ToPanc Trial: Survival After Total Versus Partial Pancreaticoduodenectomy for Adenocarcinoma of the Pancreatic Head, Distal Cholangiocarcinoma, and Ampullary Cancer

RecruitingNAAges 18 Years - anyAllInsel Gruppe AG, University Hospital Bern
NCT06801899 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
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What it tests

  • Total pancreatectomy (TP)
  • Partial pancreaticoduodenectomy (PD)
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Where

10 sites
Department of General, Visceral and Transplantation Surgery, University Hospital Münster
Münster, Germany
Department of General and Visceral Surgery, University Hospital Ulm
Ulm, Germany
Department of General and Visceral Surgery, Kantonsspital Aarau
Aarau, Switzerland
Department of Surgery, Kantonsspital Baden
Baden, Switzerland
Department of Visceral Surgery, University Hospital Basel
Basel, Switzerland
Inselspital, Bern University Hospital
Bern, Switzerland
Department of Visceral Surgery, University Hospital Geneva
Geneva, Switzerland
Department of General, Visceral, Endocrine and Transplantation Surgery, Kantonsspital St. Gallen
Sankt Gallen, Switzerland

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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