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

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Jan 29, 2025

Keywords

ClinConnect Summary

The ToPanc Trial is a research study looking at two different surgical options for patients with certain types of pancreatic cancer. Specifically, it aims to find out if completely removing the pancreas (total pancreaticoduodenectomy) can help patients live longer and maintain a good quality of life compared to only partially removing it (partial pancreaticoduodenectomy). This study focuses on patients who are considered at high risk for complications related to the surgery, particularly those who might face issues like pancreatic leakage after the operation.

To be eligible for this trial, participants need to be adults aged 18 and older who are scheduled for surgery due to specific types of cancer, including pancreatic ductal adenocarcinoma and ampullary cancer. They must also be identified as having a higher risk of developing complications after surgery. If you decide to participate, you will have two blood samples taken at different times and fill out some questionnaires to help the researchers gather important information. This trial is not yet recruiting participants, so more details will be available once it starts.

Gender

ALL

Eligibility criteria

• 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.