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

NCT06801899 · tracked via the Priya Life Science Germany tracker

Sponsor

Insel Gruppe AG, University Hospital Bern

Phase

Not applicable

Started

2026-06-01

Last updated

2026-08-12

Condition(s) studied

Pancreatic Cancer

Investigational drug(s) / intervention(s)

Total pancreatectomy (TP)Partial pancreaticoduodenectomy (PD)

Total pancreatectomy (TP): The investigators perform TP in patients who undergo surgical resection of a malignant tumor in the pancreatic head.

Partial pancreaticoduodenectomy (PD): The investigators perform partial PD with anastomosis of the pancreas in patients who undergo surgical resection of a malignant tumor in the pancreatic head. This is the current standard procedure.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Overall survival (OS) — At 2 years
Number of participants who survived for 2 years after surgery.

Trial sites (10)

Facility	City	Region	Status
Department of General, Visceral and Transplantation Surgery, University Hospital Münster	Münster	Germany	Recruiting
Department of General and Visceral Surgery, University Hospital Ulm	Ulm	Germany	Recruiting
Department of General and Visceral Surgery, Kantonsspital Aarau	Aarau	Switzerland	Recruiting
Department of Surgery, Kantonsspital Baden	Baden	Switzerland	Recruiting
Department of Visceral Surgery, University Hospital Basel	Basel	Switzerland	Recruiting
Inselspital, Bern University Hospital	Bern	Switzerland	Recruiting
Department of Visceral Surgery, University Hospital Geneva	Geneva	Switzerland	Recruiting
Department of General, Visceral, Endocrine and Transplantation Surgery, Kantonsspital St. Gallen	Sankt Gallen	Switzerland	Recruiting
Department of Surgery, Stadtspital Triemli Zürich	Zurich	Switzerland	Recruiting
Department of Surgery and Transplantation, University Hospital Zürich	Zurich	Switzerland	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06801899 on ClinicalTrials.gov ↗ ← All trials in Germany