Preventing complications after high-risk Whipple (pancreatoduodenectomy) with hydrocortisone, octreotide, and a teres ligament patch

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

PANENCA is an international, multicenter, randomized superiority phase 4 trial that compares a standardized perioperative 'HOP' bundle to usual care for patients undergoing high‑risk pancreatoduodenectomy. High risk is defined as a main pancreatic duct diameter ≤3 mm on preoperative CT or MRI, and eligible patients are randomized at participating centers around the time of surgery. The HOP bundle combines perioperative intravenous hydrocortisone, subcutaneous octreotide, and placement of a teres ligament patch to protect the pancreatic anastomosis, given during induction and continued into the early postoperative period. The primary goal is to reduce major postoperative complications related to postoperative pancreatic fistula, with safety monitoring and follow-up to capture recovery and impact on subsequent cancer treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Amsterdam UMC
  Amsterdam, Netherlands Recruiting

Study contacts

• Study coordinator: Sterre Bosscha, BSc
• Email: s.r.bosscha@amsterdamumc.nl
• Phone: +31622534263

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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.