Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
460
Countries
7
Sites
23
Pancreatic conditions requiring pancreaticoduodenectomy, such as pancreatic head carcinoma or intraductal papillary mucinous neoplasms (IPMN).
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
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Trial duration
- 21 Aug 2025 → ongoing
- Decision date (initial)
- 2026-03-26
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Deltaplan Alvleesklierkanker
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Prophylaxis
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
Secondary objectives 1
- The secondary objective is the effect of a combined treatment with hydrocortisone, octreotide, teres patch (HOP bundle) on the incidence of postoperative pancreatic fistulas grade B/C.
Conditions and MedDRA coding
Pancreatic conditions requiring pancreaticoduodenectomy, such as pancreatic head carcinoma or intraductal papillary mucinous neoplasms (IPMN).
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10033608 | Pancreatic cancer resectable | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Elective pancreatoduodenectomy for any indication (both minimally invasive and open)
- Pancreatic duct diameter ≤ 3mm on preoperative CT or MRI
- Age >18 years
Exclusion criteria 5
- <18 years old
- Pregnant
- Known allergy/hypersensitivity to hydrocortisone or octreotide
- Systemic fungal infection
- Concomitant use of CYP3A4 inhibitors and inducers, (see PROTOCOL CYTOCHROME P450 DRUG INTERACTION TABLE (iu.edu))
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Rate of Major Complications, defined as a Clavien-Dindo score of ≥III and/or postoperative abdominal drain placement
Secondary endpoints 14
- Rate of postoperative pancreatic fistula (POPF)* grade B/C. as defined by the international studygroup for pancreatic surgery (ISGPS)
- Rate of delayed gastric emptying (DGE) according to the ISGPS definition
- Rate of post pancreatectomy hemorrhage (PPH) according to the ISGPS definition
- Rate of chyle leakage (CL) according to the ISGPS definition
- Rate of bile leakage (BL) according to the ISGPS definition
- Rate of post-pancreatectomy acute pancreatitis (PPAP)
- Reintervention during admission/re-admission (either radiological, surgical or endoscopic)
- Adverse drug reactions to hydrocortisone and octreotide
- Multi-organ failure during admission/re-admission
- ICU admission
- Time to functional recovery
- Length of hospital stay in days during admission/re-admission
- Readmission within 90 days after surgery
- In-hospital and 90-day mortality
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Octreotide Lyomark 0,1 mg/ml oplossing voor injectie
PRD2495340 · Product
- Active substance
- Octreotide Acetate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 1.5 mg milligram(s)
- Max total dose
- 10.5 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- H01CB02 — OCTREOTIDE
- Marketing authorisation
- RVG 33391
- MA holder
- LYOMARK PHARMA GMBH
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Solu-Cortef, poeder voor injectievloeistof, 100 mg
PRD375974 · Product
- Active substance
- Hydrocortisone
- Substance synonyms
- CORTISOL
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVASCULAR USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB09 — HYDROCORTISONE
- Marketing authorisation
- RVG 00608
- MA holder
- PFIZER B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Marc Besselink
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Marc Besselink
Locations
7 EU/EEA countries · 23 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 30 | 1 |
| Denmark | Authorised, recruitment pending | 30 | 1 |
| Finland | Ongoing, recruiting | 25 | 1 |
| Italy | Not authorised | 75 | 3 |
| Netherlands | Ongoing, recruiting | 200 | 12 |
| Norway | Ongoing, recruiting | 25 | 1 |
| Sweden | Ongoing, recruiting | 75 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Rigshospitalet
Dept. of Digestive Diseases, Transplantation and General Surgery, Inge Lehmanns Vej 7, 2100, Copenhagen Oe
HUS-Yhtymae
Gastroenterological Surgery / Transplantation and Liver Surgery, Stenbackinkatu 9, 00290, Helsinki
Ospedale San Raffaele S.r.l.
Division of Pancreatic Surgery, Pancreas Translational and Clinical Research Center, Via Olgettina 60, 20132, Milan
Azienda Ospedaliera di Padova
HPB Surgery and Liver Transplant, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Ospedaliera Universitaria Integrata Verona
General and Pancreatic Surgery Department, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Isala Klinieken Stichting
Surgery, Dokter Van Heesweg 2, 8025 AB, Zwolle
Medisch Spectrum Twente
HPB surgery, Koningsplein 1, 7512 KZ, Enschede
Universitair Medisch Centrum Groningen
Department of Surgery, Division of Hepato-Pancreato-Biliary Surgery and Liver Transplantation, Hanzeplein 1, 9713 GZ, Groningen
Academisch Ziekenhuis Maastricht
Department of Hepato-Pancreato-Biliary Surgery, P Debyelaan 25, 6229 HX, Maastricht
Amsterdam UMC Stichting
Surgery, Cancer Center Amsterdam & Amsterdam Gastroenterology Endocrinology Metabolism, De Boelelaan 1117, 1081 HV, Amsterdam
Radboud universitair medisch centrum Stichting
HPB Surgeon, department GI/Oncological Surgery, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Catharina Ziekenhuis Stichting
Surgery, Michelangelolaan 2, 5623 EJ, Eindhoven
Jeroen Bosch Ziekenhuis Stichting
Chirurgie, Henri Dunantstraat 1, 5223 GZ, 'S-Hertogenbosch
St. Antonius Ziekenhuis
HPB surgery, Soestwetering 1, 3543 AZ, Utrecht
Leiden University Medical Center
Surgery, Albinusdreef 2, 2333 ZA, Leiden
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Hepato-Pancreato-Biliair Chirurg en Chirurgisch Oncoloog, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Stichting OLVG
Surgery HPB and colorectal, Oosterpark 9, 1091 AC, Amsterdam
Oslo University Hospital HF
Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital, Rikshospitalet, Sognsvannsveien 20, 0372, Oslo
Region Oestergoetland
Surgery, Universitetssjukhuset I, 58185, Linkoping
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Sugery, Bla Straket 5, Goteborgs Annedal, Goteborg
Skånes Universitetssjukhus
Surgery, Remissgatan 4, 22242, Lund
Karolinska University Hospital
Upper Abdominal Diseases/ surgery, Kirurgigaten 53, 141 86, Stockholm
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Finland | 2026-03-09 | 2026-03-24 | |||
| Netherlands | 2025-08-21 | 2025-08-21 | |||
| Norway | 2026-03-01 | 2026-03-04 | |||
| Sweden | 2026-03-01 | 2026-03-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 31 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-519667-18-00 | 2.0 |
| Recruitment arrangements (for publication) | K1__Recruitment arrangements | 1.1 |
| Recruitment arrangements (for publication) | K1__Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1__Recruitment arrangements | 1.1 |
| Recruitment arrangements (for publication) | K1__Recruitment arrangements | 1.1 |
| Recruitment arrangements (for publication) | K1__Recruitment arrangements | 1.1 |
| Recruitment arrangements (for publication) | K1__Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1__Recruitment arrangements SE | 1 |
| Recruitment arrangements (for publication) | K1__Recruitment arrangements Tracked Changes | 1.1 |
| Recruitment arrangements (for publication) | K1__Recruitment arrangements tracked changes | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF _Informativa e consenso trattamento dati | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF DK | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF DK Tracked changes | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF HUS EN | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF HUS FI | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Modulo_consenso_adulti | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF NL | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF NL-BE | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF NO | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF NO_track changes | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF SE | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Lettera MMG | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Sponsor Statement EN | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC EN Hydrocortisone | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC EN Octreotide | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis En 2024-519667-18-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_Fi 2024-519667-18-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT 2024-519667-18-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NO 2024-519667-18-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SV 2024-519667-18-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synposis Ne 2024-519667-18-00 | 1.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-16 | Netherlands | Acceptable 2025-05-13
|
2025-07-23 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2026-01-16 | 2026-03-26 | ||
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2026-01-28 | 2026-04-20 | ||
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-02-03 | Netherlands | Acceptable | 2026-02-11 |