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

Sponsor
Insel Gruppe AG, University Hospital Bern
Study ID
NCT06801899
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Total pancreatectomy (TP) — PROCEDURE
    The investigators perform TP in patients who undergo surgical resection of a malignant tumor in the pancreatic head.
  • Partial pancreaticoduodenectomy (PD) — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Jan 30, 2025
Start date
Jun 1, 2026
Status verified
Aug 2025
Primary completion
Oct 31, 2030
Completion
Oct 31, 2030

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Total pancreatectomy (TP)
  • Active Comparator: Pancreaticoduodenectomy (PD)

Primary Outcome Measure

Overall survival (OS) [ Time Frame: At 2 years ]

Central Contacts

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