Total versus partial pancreas removal for cancers of the pancreatic head, distal bile duct, and ampulla

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional trial compares total pancreatectomy (removal of the whole pancreas) to standard partial pancreaticoduodenectomy in adults with resectable pancreatic head, distal cholangiocarcinoma, or ampullary (pancreatobiliary type) cancers judged to have a high-risk pancreatic anastomosis. Patients give informed consent, provide two small blood samples (preoperative and during hospitalization), and complete quality-of-life questionnaires; surgery and routine follow-up occur at participating Swiss centers. The trial measures overall survival and quality of life as primary outcomes, with attention to postoperative pancreatic fistula rates and metabolic consequences such as need for lifelong insulin and enzyme replacement. If randomized, treatments and outcomes will be compared to see whether total pancreatectomy reduces leak-related complications and affects long-term survival and daily functioning.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of General, Visceral and Transplantation Surgery, University Hospital Münster
  Münster, Germany Recruiting
• Department of General and Visceral Surgery, University Hospital Ulm
  Ulm, Germany Recruiting
• Department of General and Visceral Surgery, Kantonsspital Aarau
  Aarau, Switzerland Recruiting
• Department of Surgery, Kantonsspital Baden
  Baden, Switzerland Recruiting
• Department of Visceral Surgery, University Hospital Basel
  Basel, Switzerland Recruiting
• Inselspital, Bern University Hospital
  Bern, Switzerland Recruiting

Study contacts

• Principal investigator: Anna S Wenning, MD, PhD — Department of Visceral Surgery and Medicine Inselspital, Bern University Hospital
• Study coordinator: Anna S Wenning, MD, PhD
• Email: annasilvia.wenning@insel.ch
• Phone: +41 (0)31 632 71 41

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.