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

RecruitingPhase 4Ages 18 Years - anyAllAcademisch Medisch Centrum - Universiteit van Ams…
NCT07262957 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Thes

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📋 Eligibility rules (as published)
Inclusion Criteria: * Elective pancreatoduodenectomy for any indication (both minimally invasive and open) * Pancreatic duct diameter ≤ 3mm on preoperative CT or MRI\* * 18 years of age or older * Signature of informed consent * In the opinion of the investigator, the patient is eligible for the administration of hydrocortisone and octreotide, based on contraindications, warnings, and precautions as listed in the respective SmPCs Exclusion Criteria: * Age \< 18 years * Pregnancy or current breastfeeding * Known allergy or hypersensitivity to hydrocortisone or octreotide * Systemic fungal infection * Concomitant use of strong CYP3A4 inhibitors or moderate-to-strong inducers that cannot be discontinued (see CYTOCHROME P450 DRUG INTERACTION TABLE (iu.edu)) * Inhibitors must be discontinued ≥7 days before randomization * Inducers must be discontinued ≥28 days before randomization
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What it tests

  • HOP bundle
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Where

1 site
Amsterdam UMC
Amsterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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