Clinical trial • Phase IV • Oncology|Other

Hydrocortisone for Pancreatic cancer (resectable, head of pancreas) | Intraductal papillary mucinous neoplasm (IPMN)

Phase IV trial of Hydrocortisone for Pancreatic cancer (resectable, head of pancreas) | Intraductal papillary mucinous neoplasm (IPMN). Randomised.

Overview

Trial Therapeutic Area
Oncology|Other
Trial Disease
Pancreatic cancer (resectable, head of pancreas) | Intraductal papillary mucinous neoplasm (IPMN)
Trial Stage
Phase IV
Drug Modality
Small molecule|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
16-01-2025
First CTIS Authorization Date
23-07-2025

Trial design

Randomised Phase IV trial in Finland, Italy, Sweden and others.

Randomised
Yes
Target Sample Size
460
Trial Duration For Participant
90

Eligibility

Recruits 460 No vulnerable population selected; participants must be adults (>18 years). Informed consent is obtained from participants using subject information and informed consent forms (SIS and ICF) provided in country-specific language versions..

Pregnancy Exclusion
Pregnant
Vulnerable Population
No vulnerable population selected; participants must be adults (>18 years). Informed consent is obtained from participants using subject information and informed consent forms (SIS and ICF) provided in country-specific language versions.

Inclusion criteria

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

Exclusion criteria

  • {"criterion_text":"- <18 years old"}
  • {"criterion_text":"- Pregnant"}
  • {"criterion_text":"- Known allergy/hypersensitivity to hydrocortisone or octreotide"}
  • {"criterion_text":"- Systemic fungal infection"}
  • {"criterion_text":"- Concomitant use of CYP3A4 inhibitors and inducers, (see PROTOCOL CYTOCHROME P450 DRUG INTERACTION TABLE (iu.edu))"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Rate of Major Complications, defined as a Clavien-Dindo score of ≥III and/or postoperative abdominal drain placement","definition_or_measurement_approach":"Defined as a Clavien-Dindo score of ≥III and/or postoperative abdominal drain placement"}

Secondary endpoints

  • {"endpoint_text":"- Rate of postoperative pancreatic fistula (POPF)* grade B/C. as defined by the international studygroup for pancreatic surgery (ISGPS)","definition_or_measurement_approach":"As defined by the International Study Group for Pancreatic Surgery (ISGPS)"}
  • {"endpoint_text":"- Rate of delayed gastric emptying (DGE) according to the ISGPS definition","definition_or_measurement_approach":"According to the ISGPS definition"}
  • {"endpoint_text":"- Rate of post pancreatectomy hemorrhage (PPH) according to the ISGPS definition","definition_or_measurement_approach":"According to the ISGPS definition"}
  • {"endpoint_text":"- Rate of chyle leakage (CL) according to the ISGPS definition","definition_or_measurement_approach":"According to the ISGPS definition"}
  • {"endpoint_text":"- Rate of bile leakage (BL) according to the ISGPS definition","definition_or_measurement_approach":"According to the ISGPS definition"}
  • {"endpoint_text":"- Rate of post-pancreatectomy acute pancreatitis (PPAP)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Reintervention during admission/re-admission (either radiological, surgical or endoscopic)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Adverse drug reactions to hydrocortisone and octreotide","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Multi-organ failure during admission/re-admission","definition_or_measurement_approach":""}
  • {"endpoint_text":"- ICU admission","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Time to functional recovery","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Length of hospital stay in days during admission/re-admission","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Readmission within 90 days after surgery","definition_or_measurement_approach":"Readmission assessed within 90 days after surgery"}
  • {"endpoint_text":"- In-hospital and 90-day mortality","definition_or_measurement_approach":"Mortality assessed in-hospital and within 90 days after surgery"}

Recruitment

Planned Sample Size
460
Recruitment Window Months
24
Consent Approach
Informed consent obtained from participants (adults >18 years) via subject information and informed consent forms (SIS and ICF). Country-specific language versions of SIS/ICF are provided (examples in the documentation: EN, FI, SE, NO, NL, DK). No assent procedures specified.

Geography

Total Number Of Sites
23
Total Number Of Participants
460

Finland

Earliest CTIS Part Ii Submission Date
12-07-2025
Latest Decision Or Authorization Date
28-07-2025
Processing Time Days
16
Number Of Sites
1
Number Of Participants
25

Sites

Site Name
HUS-Yhtymae
Department Name
Gastroenterological Surgery / Transplantation and Liver Surgery
Contact Person Name
Ville Sallinen
Contact Person Email
ville.sallinen@helsinki.fi

Italy

Earliest CTIS Part Ii Submission Date
20-10-2025
Latest Decision Or Authorization Date
29-10-2025
Processing Time Days
9
Number Of Sites
3
Number Of Participants
75

Sites

Site Name
Ospedale San Raffaele S.r.l.
Department Name
Division of Pancreatic Surgery, Pancreas Translational and Clinical Research Center
Contact Person Name
Massimo Falconi
Contact Person Email
falconi.massimo@hsr.t
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
General and Pancreatic Surgery Department
Contact Person Name
Roberto Salvia
Contact Person Email
roberto.salvia@univr.it
Site Name
Azienda Ospedaliera di Padova
Department Name
HPB Surgery and Liver Transplant
Contact Person Name
Giovanni Marchegiani
Contact Person Email
giovanni.marchegiani@unipd.it

Sweden

Earliest CTIS Part Ii Submission Date
26-08-2025
Latest Decision Or Authorization Date
02-09-2025
Processing Time Days
7
Number Of Sites
4
Number Of Participants
75

Sites

Site Name
Region Oestergoetland (Universitetssjukhuset I)
Department Name
Surgery
Contact Person Name
Bergthór Björnsson
Contact Person Email
Bergthor.bjornsson@liu.se
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Sugery
Contact Person Name
Elena Rangelova
Contact Person Email
elena.rangelova@gu.se
Site Name
Karolinska University Hospital
Department Name
Upper Abdominal Diseases/ surgery
Contact Person Name
Ernesto Sparrelid
Site Name
Skånes Universitetssjukhus
Department Name
Surgery
Contact Person Name
Bobby Tingstedt
Contact Person Email
bobby.tingstedt@med.lu.se

Norway

Earliest CTIS Part Ii Submission Date
04-09-2025
Latest Decision Or Authorization Date
05-09-2025
Processing Time Days
1
Number Of Sites
1
Number Of Participants
25

Sites

Site Name
Oslo University Hospital HF
Department Name
Department of Hepato-Pancreato-Biliary Surgery, Oslo University Hospital, Rikshospitalet
Contact Person Name
Knut Jørgen Labori
Contact Person Email
k.j.labori@medisin.uio.no

Belgium

Earliest CTIS Part Ii Submission Date
18-03-2026
Latest Decision Or Authorization Date
26-03-2026
Processing Time Days
8
Number Of Sites
1
Number Of Participants
30

Sites

Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Surgery
Contact Person Name
Geert Roeyen
Contact Person Email
geert.roeyen@uza.be

Denmark

Earliest CTIS Part Ii Submission Date
10-04-2026
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
10
Number Of Sites
1
Number Of Participants
30

Sites

Site Name
Rigshospitalet
Department Name
Dept. of Digestive Diseases, Transplantation and General Surgery
Contact Person Name
Stefan Burgdorf

Netherlands

Earliest CTIS Part Ii Submission Date
16-07-2025
Latest Decision Or Authorization Date
23-07-2025
Processing Time Days
7
Number Of Sites
12
Number Of Participants
200

Sites

Site Name
Medisch Spectrum Twente
Department Name
HPB surgery
Contact Person Name
Daan Lips
Contact Person Email
d.lips@mst.nl
Site Name
Jeroen Bosch Ziekenhuis Stichting
Department Name
Chirurgie
Contact Person Name
Koop Bosscha
Contact Person Email
k.bosscha@jbz.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Department of Hepato-Pancreato-Biliary Surgery
Contact Person Name
Marcel den Dulk
Contact Person Email
marcel.den.dulk@mumc.nl
Site Name
Stichting OLVG
Department Name
Surgery HPB and colorectal
Contact Person Name
Michael Gerhards
Contact Person Email
m.f.gerhards@olvg.nl
Site Name
Catharina Ziekenhuis Stichting
Department Name
Surgery
Contact Person Name
Misha Luyer
Site Name
Isala Klinieken Stichting
Department Name
Surgery
Contact Person Name
Gijs Patijn
Contact Person Email
g.a.patijn@isala.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Hepato-Pancreato-Biliair Chirurg en Chirurgisch Oncoloog
Contact Person Name
Bas Groot Koerkamp
Contact Person Email
b.grootkoerkamp@erasmusmc.nl
Site Name
St. Antonius Ziekenhuis
Department Name
HPB surgery
Contact Person Name
Hjalmar van Santvoort
Site Name
Amsterdam UMC Stichting
Department Name
Surgery, Cancer Center Amsterdam & Amsterdam Gastroenterology Endocrinology Metabolism
Contact Person Name
Marc Besselink
Contact Person Email
ctis@amsterdamumc.nl
Site Name
Leiden University Medical Center
Department Name
Surgery
Contact Person Name
Bert Bonsing
Contact Person Email
b.a.bonsing@lumc.nl
Site Name
Radboud universitair medisch centrum Stichting
Department Name
HPB Surgeon, department GI/Oncological Surgery
Contact Person Name
Martijn Stommel
Contact Person Email
Martijn.Stommel@RadboudUMC.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Department of Surgery, Division of Hepato-Pancreato-Biliary Surgery and Liver Transplantation
Contact Person Name
Joost Klaasse
Contact Person Email
j.m.klaase@umcg.nl

Sponsor

Primary sponsor

Full Name
Amsterdam UMC Stichting
Organisation Type
Patient organisation/association
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
Solu-Cortef, poeder voor injectievloeistof, 100 mg
Active Substance
Hydrocortisone
Modality
Small molecule
Routes Of Administration
INTRAVASCULAR USE
Route
INTRAVASCULAR USE
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
500 mg (max daily dose)
Investigational Product Name
Octreotide Lyomark 0,1 mg/ml oplossing voor injectie
Active Substance
Octreotide acetate
Modality
Peptide/protein/enzyme
Routes Of Administration
SUBCUTANEOUS
Route
SUBCUTANEOUS
Authorisation Status
Authorised (marketing authorisation present)
Maximum Dose
1.5 mg (max daily dose)
Combination Treatment
Yes

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