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NCT06801899Recruiting

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

Official recordSimplified version

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.

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.

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
No phase (N/A)
Study type
Interventional
Countries
Switzerland, Germany
Sponsor
Insel Gruppe AG, University Hospital Bern(Other)
Protocol no.
2024-02010
Conditions
Pancreatic Cancer
Interventions
Procedure

Treatments studied

  • Total pancreatectomy (TP)
  • Partial pancreaticoduodenectomy (PD)

Locations · 10

  • Aarau, SwitzerlandDepartment of General and Visceral Surgery, Kantonsspital AarauRecruiting at this site
  • Baden, SwitzerlandDepartment of Surgery, Kantonsspital BadenRecruiting at this site
  • Basel, SwitzerlandDepartment of Visceral Surgery, University Hospital BaselRecruiting at this site
  • Bern, SwitzerlandInselspital, Bern University HospitalRecruiting at this site
  • Geneva, SwitzerlandDepartment of Visceral Surgery, University Hospital GenevaRecruiting at this site
  • Sankt Gallen, SwitzerlandDepartment of General, Visceral, Endocrine and Transplantation Surgery, Kantonsspital St. GallenRecruiting at this site
  • Zurich, SwitzerlandDepartment of Surgery, Stadtspital Triemli ZürichRecruiting at this site
  • Zurich, SwitzerlandDepartment of Surgery and Transplantation, University Hospital ZürichRecruiting at this site
  • Münster, GermanyDepartment of General, Visceral and Transplantation Surgery, University Hospital MünsterRecruiting at this site
  • Ulm, GermanyDepartment of General and Visceral Surgery, University Hospital UlmRecruiting at this site

In total, worldwide, all 10 sites listed in the registry are recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: August 12, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.