RecruitingNot ApplicableNCT06801899

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

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

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

170 participants

Start Date

May 12, 2025

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer

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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria4

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.

Interventions

PROCEDURETotal pancreatectomy (TP)

The investigators perform TP in patients who undergo surgical resection of a malignant tumor in the pancreatic head.

PROCEDUREPartial pancreaticoduodenectomy (PD)

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.