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2024-519667-18-00RecruitingPhase 4

Preventing postoperative complications in patients undergoing high-risk pancreatoduodenectomy with a bundle approach including hydrocortisone, ocreotide, and teres ligament patch (PANENCA): an international randomized controlled multicenter trial

Source: EU CTIS (euclinicaltrials.eu) · Last updated 17 Sept 2026

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Brief summary (registry, in English)

The primary aim of the PANENCA trial is to investigate the effect of a combined treatment with hydrocortisone, octreotide, teres patch (HOP bundle) on major complications after pancreatoduodenectomy

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
460 (estimated)
First submitted
16 Jan 2025
Start date
21 Aug 2025
Lead sponsor
Amsterdam UMC Stichting
EU CT number
2024-519667-18-00

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 460
  • 24 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who will have planned surgery to remove part of the pancreas (pancreatoduodenectomy) and who have a narrow pancreatic duct.

Age
Over 18 years
Sex
All sexes
Disease stage
Planned pancreatoduodenectomy for any reason, open or minimally invasive surgery. Pancreatic duct width of 3 mm or less on a CT or MRI scan before surgery.

Main reasons for not taking part

  • Under 18 years old
  • Pregnant
  • Known allergy to hydrocortisone or octreotide
  • Fungal infection throughout the body
  • Taking CYP3A4 inhibitor or inducer drugs

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concomitant use of CYP3A4 inhibitors and inducers, (see PROTOCOL CYTOCHROME P450 DRUG INTERACTION TABLE (iu.edu))

Other illness

  • Known allergy/hypersensitivity to hydrocortisone or octreotide
  • Systemic fungal infection

Age

  • <18 years old

Other

  • Pregnant

Who the study is looking for

  • Elective pancreatoduodenectomy for any indication (both minimally invasive and open)
  • Pancreatic duct diameter ≤ 3mm on preoperative CT or MRI
  • Age >18 years

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (24)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Universitair Ziekenhuis AntwerpenEdegemBelgiumRecruiting
Region MidtjyllandAarhus NDenmarkRecruiting
RigshospitaletCopenhagen OeDenmarkRecruiting
HUS-YhtymaeHelsinkiFinlandRecruiting
Ospedale San Raffaele S.r.l.MilanItalyWithdrawn
Azienda Ospedaliera di PadovaPadovaItalyWithdrawn
Azienda Ospedaliera Universitaria Integrata VeronaVeronaItalyWithdrawn
Stichting OLVGAmsterdamNetherlandsRecruiting
Amsterdam UMC StichtingAmsterdamNetherlandsRecruiting
Catharina Ziekenhuis StichtingEindhovenNetherlandsRecruiting
Medisch Spectrum TwenteEnschedeNetherlandsRecruiting
Universitair Medisch Centrum GroningenGroningenNetherlandsRecruiting
Leiden University Medical CenterLeidenNetherlandsRecruiting
Academisch Ziekenhuis MaastrichtMaastrichtNetherlandsRecruiting
Radboud universitair medisch centrum StichtingNijmegenNetherlandsRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)RotterdamNetherlandsRecruiting
Jeroen Bosch Ziekenhuis Stichting'S-HertogenboschNetherlandsRecruiting
St Antonius ZiekenhuisUtrechtNetherlandsRecruiting
Isala Klinieken StichtingZwolleNetherlandsRecruiting
Oslo University Hospital HFOsloNorwayRecruiting
Sahlgrenska University Hospital-Vaestra GoetalandsregionenGoteborgSwedenRecruiting
Region OestergoetlandLinkopingSwedenRecruiting
Skanes universitetssjukhusLundSwedenRecruiting
Karolinska University HospitalStockholmSwedenRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.