ToPanc Trial: Survival After Total Versus Partial Pancreaticoduodenectomy for Adenocarcinoma of the Pancreatic Head, Distal Cholangiocarcinoma, and Ampullary Cancer
Recruiting · NCT06801899 · Interventional (participants receive a specific treatment) · Lead sponsor: Insel Gruppe AG, University Hospital Bern
View the official record on ClinicalTrials.gov →Interventions studied
Partial pancreaticoduodenectomy (PD)Total pancreatectomy (TP)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
10 locations listed.
- 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 and Transplantation Surgery, University Hospital Münster - Münster, Germany
- Department of General, Visceral, Endocrine and Transplantation Surgery, Kantonsspital St. Gallen - Sankt Gallen, Switzerland
- Department of General and Visceral Surgery, University Hospital Ulm - Ulm, Germany
- Department of Surgery, Stadtspital Triemli Zürich - Zurich, Switzerland
- Department of Surgery and Transplantation, University Hospital Zürich - Zurich, Switzerland