ToPanc Trial: Survival After Total Versus Partial Pancreaticoduodenectomy for Adenocarcino
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 qua
| Condition(s) | Pancreatic Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Insel Gruppe AG, University Hospital Bern |
| Locations | Baden, Switzerland; Basel, Switzerland; Bern, Switzerland; Geneva, Switzerland; Sankt Gallen, Switzerland; Zurich, Switzerland (+1 more sites) |
| Start date | 2025-05-12 |
| NCT ID | NCT06801899 |
| Official listing | https://clinicaltrials.gov/study/NCT06801899 |