ToPanc Trial: Survival After Total Versus Partial Pancreaticoduodenectomy for Adenocarcinoma of the Pancreatic Head, Distal Cholangiocarcinoma, and Ampullary Cancer
ToPanc
1 other identifier
interventional
170
2 countries
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pancreatic-cancer
Started Jun 2026
Typical duration for not_applicable pancreatic-cancer
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2025
CompletedFirst Posted
Study publicly available on registry
January 30, 2025
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2030
July 21, 2026
August 1, 2025
4.3 years
January 24, 2025
July 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival (OS)
Number of participants who survived for 2 years after surgery.
At 2 years
Secondary Outcomes (12)
Quality of Life (QoL) Pancreatic Cancer
At 0.5 year, at 1 year, at 2 years
Quality of Life (QoL) Diabetes
At 0.5 year, at 1 year, at 2 years
Postoperative complications (discriminating minor and major complications)
Within 90 day of surgery
Mortality
Within 90 days of surgery
Length of hospital stay in days
Within 90 days of surgery
- +7 more secondary outcomes
Study Arms (2)
Total pancreatectomy (TP)
EXPERIMENTALPancreaticoduodenectomy (PD)
ACTIVE COMPARATORInterventions
The investigators perform TP in patients who undergo surgical resection of a malignant tumor in the pancreatic head.
The investigators perform partial PD with anastomosis of the pancreas in patients who undergo surgical resection of a malignant tumor in the pancreatic head. This is the current standard procedure.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Department of General, Visceral and Transplantation Surgery, University Hospital Münster
Münster, 48149, Germany
Department of General and Visceral Surgery, University Hospital Ulm
Ulm, 89081, Germany
Department of General and Visceral Surgery, Kantonsspital Aarau
Aarau, 5001, Switzerland
Department of Surgery, Kantonsspital Baden
Baden, 5404, Switzerland
Department of Visceral Surgery, University Hospital Basel
Basel, 4031, Switzerland
Inselspital, Bern University Hospital
Bern, 3010, Switzerland
Department of Visceral Surgery, University Hospital Geneva
Geneva, 1205, Switzerland
Department of General, Visceral, Endocrine and Transplantation Surgery, Kantonsspital St. Gallen
Sankt Gallen, 9000, Switzerland
Department of Surgery, Stadtspital Triemli Zürich
Zurich, 8063, Switzerland
Department of Surgery and Transplantation, University Hospital Zürich
Zurich, 8091, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna S Wenning, MD, PhD
Department of Visceral Surgery and Medicine Inselspital, Bern University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2025
First Posted
January 30, 2025
Study Start
June 1, 2026
Primary Completion (Estimated)
October 1, 2030
Study Completion (Estimated)
October 1, 2030
Last Updated
July 21, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share