Preventing Postoperative Complications in Patients Undergoing High-risk Pancreatoduodenectomy With a Bundle Approach Including Hydrocortisone, Octreotide, and the Teres Ligament Patch (PANENCA)

The PANENCA trial aims to reduce postoperative complications in patients undergoing pancreatoduodenectomy (also known as a Whipple procedure), a complex surgical operation performed to remove tumors located in or near the head of the pancreas. One of the most frequent and serious complications after this surgery is postoperative pancreatic fistula (POPF), a leakage of pancreatic fluid from the surgical connection. POPF can lead to intra-abdominal infection, bleeding, and inflammation, often resulting in delayed recovery and postponement of subsequent oncological treatment. In severe cases, these complications may be life-threatening. Patients with a small main pancreatic duct (3 millimeters or less) are known to have a substantially higher risk of developing POPF. Previous studies have shown that several existing interventions may reduce the risk or severity of these complications. These include hydrocortisone, a medication that suppresses postoperative inflammation; octreotide, a medication that reduces the production of pancreatic secretions; and a surgical technique known as the ligamentum teres hepatis patch, which uses the patient's own tissue to protect nearby blood vessels in the event of a pancreatic leak. Because the development of pancreatic fistulas is multifactorial, the investigators hypothesize that a combined approach targeting different underlying mechanisms may provide a complementary and more effective protective effect than any single intervention alone. The PANENCA trial therefore evaluates whether the combined use of hydrocortisone, octreotide, and the ligamentum teres patch can reduce the rate of major postoperative complications after pancreatoduodenectomy. Patients participating in the study are randomly assigned to receive either the combination treatment in addition to standard perioperative care or standard perioperative care alone. The study medications are administered only during the first postoperative days, and the surgical patch is applied during the operation itself. No additional tests, monitoring procedures, or hospital visits are required beyond routine clinical care. This international, multicenter randomized trial includes patients at high risk for POPF who are undergoing pancreatoduodenectomy. The primary objective is to determine whether the combination treatment reduces the incidence of major postoperative complications. If proven effective, this bundle approach may be implemented more consistently across participating countries and incorporated into international clinical guidelines for pancreatic surgery.

NCT Number	NCT07262957
Lead Sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Collaborators: Erasmus Medical Center, UMC Utrecht, Medisch Spectrum Twente, Jeroen Bosch Ziekenhuis, Maastricht University Medical Center, Radboud University Medical Center, Isala, Catharina Ziekenhuis Eindhoven, Helsinki University Central Hospital, Oslo University Hospital, Karolinska University Hospital, Sahlgrenska University Hospital, University Hospital, Linkoeping, Lund University Hospital, Azienda Ospedaliera Universitaria Integrata Verona, Azienda Ospedaliera di Padova, San Raffaele University Hospital, Italy, Leiden University Medical Center, University Medical Center Groningen, Clinical Cancer Hospital, Kyiv, Rigshospitalet, Denmark, University Hospital, Antwerp
Conditions	Pancreas Head Cancer, Pancreas Adenocarcinoma, IPMN, Pancreatic, Cholangio Carcinoma, Ampulla of Vater Adenocarcinoma, PDAC - Pancreatic Ductal Adenocarcinoma, Duodenal Carcinoma, Mucinous Cystic Neoplasm +2 more
Enrollment	400 participants
Start Date	2025-09-01
Primary Completion	2027-09-01 (estimated)
Study Completion	2027-12-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-22