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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Switzerland
Department of Surgery, Kantonsspital Baden
RECRUITING
Baden
Department of Visceral Surgery, University Hospital Basel
NOT_YET_RECRUITING
Basel
Inselspital, Bern University Hospital
RECRUITING
Bern
Department of Visceral Surgery, University Hospital Geneva
RECRUITING
Geneva
Department of General, Visceral, Endocrine and Transplantation Surgery, Kantonsspital St. Gallen
RECRUITING
Sankt Gallen
Department of Surgery and Transplantation, University Hospital Zürich
RECRUITING
Zurich
Department of Surgery, Stadtspital Triemli Zürich
NOT_YET_RECRUITING
Zurich
Contact Information
Primary
Anna S Wenning, MD, PhD
annasilvia.wenning@insel.ch
+41 (0)31 632 71 41
Backup
Nadine Uebersax
nadine.uebersax@unibe.ch
+41 (0)31 684 33 69
Time Frame
Start Date: 2025-05-12
Estimated Completion Date: 2029-07
Participants
Target number of participants: 170
Treatments
Experimental: Total pancreatectomy (TP)
Active_comparator: Pancreaticoduodenectomy (PD)
Sponsors
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov