Total versus partial pancreas removal for cancers of the pancreatic head, distal bile duct, and ampulla
ToPanc Trial: Survival After Total Versus Partial Pancreaticoduodenectomy for Adenocarcinoma of the Pancreatic Head, Distal Cholangiocarcinoma, and Ampullary Cancer: a Multi-centric Randomized Controlled Trial
This research will see if removing the entire pancreas instead of just the head improves survival without lowering quality of life for people with cancers of the pancreatic head, distal bile duct, or ampulla who are at high risk of a postoperative pancreatic leak.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Baden and 6 other locations) |
| Trial ID | NCT06801899 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial compares total pancreatectomy (removal of the whole pancreas) to standard partial pancreaticoduodenectomy in adults with resectable pancreatic head, distal cholangiocarcinoma, or ampullary (pancreatobiliary type) cancers judged to have a high-risk pancreatic anastomosis. Patients give informed consent, provide two small blood samples (preoperative and during hospitalization), and complete quality-of-life questionnaires; surgery and routine follow-up occur at participating Swiss centers. The trial measures overall survival and quality of life as primary outcomes, with attention to postoperative pancreatic fistula rates and metabolic consequences such as need for lifelong insulin and enzyme replacement. If randomized, treatments and outcomes will be compared to see whether total pancreatectomy reduces leak-related complications and affects long-term survival and daily functioning.
Who should consider this trial
Good fit: Adults (≥18) scheduled for pancreaticoduodenectomy for suspected or proven pancreatic ductal adenocarcinoma, distal cholangiocarcinoma, or ampullary (pancreatobiliary type) cancer who are judged by imaging to have a high-risk pancreatic anastomosis and who can give informed consent.
Not a fit: Patients with other tumor types (duodenal or intestinal-type ampullary cancers, neuroendocrine tumors), chronic pancreatitis, those not judged high-risk for pancreatic leak, or who cannot tolerate major surgery are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, this approach could improve long-term survival for high-risk patients by preventing pancreatic leaks without worsening overall quality of life.
How similar studies have performed: Total pancreatectomy has been used selectively for advanced cases to avoid leaks, but randomized evidence comparing survival and quality of life versus partial resection in high-risk anastomosis patients is limited, making this comparison relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Baden and 6 other locations
- Department of Surgery, Kantonsspital Baden — Baden, Switzerland (Recruiting)
- Department of Visceral Surgery, University Hospital Basel — Basel, Switzerland (Not_yet_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 (Not_yet_recruiting)
- Department of Surgery and Transplantation, University Hospital Zürich — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Anna S Wenning, MD, PhD — Department of Visceral Surgery and Medicine Inselspital, Bern University Hospital
- Study coordinator: Anna S Wenning, MD, PhD
- Email: annasilvia.wenning@insel.ch
- Phone: +41 (0)31 632 71 41
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.