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

NCT06801899

RecruitingNA

Sponsor: Insel Gruppe AG, University Hospital Bern

Conditions: Pancreatic Cancer

Interventions: Total pancreatectomy (TP), Partial pancreaticoduodenectomy (PD)

Countries: Germany, Switzerland

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (10)
  • Münster, Germany
  • Ulm, Germany
  • Aarau, Switzerland
  • Baden, Switzerland
  • Basel, Switzerland
  • Bern, Switzerland
  • Geneva, Switzerland
  • Sankt Gallen, Switzerland
  • Zurich, Switzerland
  • Zurich, Switzerland