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

What Was Tested

In this phase 4 trial, researchers set out to test Octreotide.

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.

It had two arms (groups): Intervention arm (HOP bundle) (experimental) and Controle arm (no intervention).

Patients in the intervention group will receive the HOP bundle approach: a combination intervention of: Hydrocortisone, octreotide and the ligamentum teres patch.

Standard care.

The registry classes the interventions as combination product.

More on the Plan

POPF remains the leading cause of morbidity and mortality following pancreatoduodenectomy.

The PANENCA trial therefore evaluates a bundled intervention (the HOP bundle) consisting of the following components: 1.

Hydrocortisone, administered intravenously starting during induction of anesthesia to attenuate the postoperative inflammatory response, which is considered a key contributor to the development of POPF.

A ligamentum teres hepatis patch, applied intraoperatively to mechanically protect the gastroduodenal artery stump from enzymatic erosion in the event of a POPF.

Who Took Part

The registry lists 400 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: age \< 18 years; pregnancy or current breastfeeding; known allergy or hypersensitivity to hydrocortisone or octreotide.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Octreotide group and the comparison group should start out alike.

The Octreotide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Octreotide study: the participants and staff both knew the treatment.

It started in 2025-09-01 with completion listed for 2027-09-01.

It ran at 1 site in Netherlands.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Major complications (time frame: Until postoperative day 90).

It also tracked 1 secondary outcome, for example Postoperative Pancreatic Fistula (POPF).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Octreotide in 400 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.