Hydrocortisone or pasireotide to prevent complications after pancreatic surgery

• Register: EUCTR
• Last refreshed on: 18 April 2016
• Main ID: EUCTR2016-000212-16-FI
• Date of registration: 30/03/2016
• Prospective Registration: Yes
• Primary sponsor: Helsinki University Central Hospital
• Public title: Hydrocortisone or pasireotide to prevent complications after pancreatic surgery
• Scientific title: Hydrocortisone vs. pasireotide in preventing pancreatic fistula and other complications after pancreatic resection - a prospective, randomized, controlled trial
• Date of first enrolment: 12/04/2016
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000212-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Finland

Contacts

• Name: MEM13
• Affiliation: Helsinki University Central Hospital

• Name: MEM13
• Affiliation: Helsinki University Central Hospital

Key inclusion & exclusion criteria

Inclusion criteria:
Patients undergoing pancreatic resection.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

Exclusion criteria:
- Atrophic pancreas, dilated main pancreatic duct at the site of pancreaticojejunostomy
- Total pancreatectomy
- Allergy to studied medications
- Age < 18 years
- No written consent
- Pancreatic resection not performed, even if planned
- Hard pancreas/dilated main pancreatic duct (only patients undergoing PD)



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Patients undergoing pancreatic resection.

Intervention(s)

Trade Name: Signifor
Pharmaceutical Form: Injection
CAS Number: 396091-73-9
Other descriptive name: PASIREOTIDE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 900-

Trade Name: Solu-Cortef
Pharmaceutical Form: Injection
Other descriptive name: HYDROCORTISONE SODIUM SUCCINATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): Comprehensive complication index

Secondary Objective: Determine oncological survival

Timepoint(s) of evaluation of this end point: 30 days postoperatively

Main Objective: Determine non-inferiority of hydrocortisone compared to pasireotide in preventing pancreatic surgery complications.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 30 days, except for adjuvant therapy 6 months.

Secondary end point(s): - Complications (C-D classification)
- Pancreatic fistula (ISGPS classification)
- DGE (ISGPS classification)
- Post-pancreatectomy hemorrhage (ISGPS classification)
- Duration of hospital stay
- Readmissions
- Number of patients who received adjuvant therapy

Secondary ID(s)

HYKS-190116

Source(s) of Monetary Support

Helsinki University Hospital - EVO funding