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

Preventing Postoperative Complications in Patients Undergoing High-risk Pancreatoduodenectomy With a Bundle Approach Including Hydrocortisone, Octreotide, and the Teres Ligament Patch (PANENCA): an International Randomized Controlled Multicenter Trial

This tests whether giving hydrocortisone and octreotide around surgery plus placing a teres ligament patch can lower major complications after Whipple surgery in patients with a small pancreatic duct.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other)
• Locations: 1 site (Amsterdam)
• Trial ID: NCT07262957 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults scheduled for elective pancreatoduodenectomy with a main pancreatic duct ≤3 mm who can safely receive hydrocortisone and octreotide and who provide informed consent.

Not a fit: Patients with a pancreatic duct >3 mm, those with contraindications to hydrocortisone or octreotide (including systemic fungal infection or relevant drug interactions), pregnant or breastfeeding patients, or those unable to have surgery at a participating center are unlikely to benefit from entering this trial.

Why it matters

Potential benefit: If successful, the bundle could substantially reduce postoperative pancreatic fistula and major complications, speeding recovery and lowering delays to further cancer treatment.

How similar studies have performed: Previous smaller or nonrandomized studies have suggested benefits from hydrocortisone, octreotide, or local patching individually, but combining these measures into a standardized bundle has not been tested in a large international randomized trial.

Eligibility criteria

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 this trial is running

Amsterdam

• Amsterdam UMC — Amsterdam, Netherlands (RECRUITING)

Study contacts

• Study coordinator: Sterre Bosscha, BSc

Conditions: Pancreas Head Cancer, Pancreas Adenocarcinoma, IPMN, Pancreatic, Cholangio Carcinoma, Ampulla of Vater Adenocarcinoma, PDAC - Pancreatic Ductal Adenocarcinoma, Duodenal Carcinoma, Mucinous Cystic Neoplasm