Taking people in DenmarkPhase 4
Preventing complications after high-risk pancreas surgery with a combined treatment bundle
Tests hydrocortisone, octreotide and a teres patch to prevent complications after pancreatoduodenectomy in adults.
Key facts
- Who runs it
- Amsterdam UMC Stichting
- Where
- Aarhus N and Copenhagen Oe, DenmarkSee the 2 sitesAlso in 6 other countries, 22 sites
- Trial code
- Registry title
- 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
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 460 people, planned
- Started
- 21 Aug 2025
- Expected to end
- 1 May 2027
- Type of study
- Interventional
- Record updated
- 17 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. 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
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Elective pancreatoduodenectomy for any indication (both minimally invasive and open)
- Pancreatic duct diameter ≤ 3mm on preoperative CT or MRI
- Age >18 years
Who cannot take part
- Concomitant use of CYP3A4 inhibitors and inducers, (see PROTOCOL CYTOCHROME P450 DRUG INTERACTION TABLE (iu.edu))
- Known allergy/hypersensitivity to hydrocortisone or octreotide
- Systemic fungal infection
- <18 years old
- Pregnant
Where in Denmark
Also in 6 other countries, 22 sites
- Region MidtjyllandAarhus N, DenmarkTaking people
- RigshospitaletCopenhagen Oe, DenmarkTaking people
About the trial
What the trial wants to find out
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
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- 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
- Plain-language title
- Preventing complications after high-risk pancreas surgery with a combined treatment bundleGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 17 September 2026