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    Clinical Trial Results:
    Hydrocortisone vs. pasireotide in preventing pancreatic fistula and other complications after pancreatic resection - a prospective, randomized, controlled trial

    Summary
    EudraCT number
    		 2016-000212-16
    Trial protocol
    		 FI  
    Global end of trial date
    26 Oct 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Feb 2025
    First version publication date
    06 Feb 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    HYKS-190116
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02775227
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Helsinki University Hospital
    Sponsor organisation address
    Haartmaninkatu 4, Helsinki, Finland, 00290
    Public contact
    MEM13, Helsinki University Central Hospital, ville.sallinen@helsinki.fi
    Scientific contact
    MEM13, Helsinki University Central Hospital, ville.sallinen@helsinki.fi
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Dec 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Dec 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Oct 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Determine non-inferiority of hydrocortisone compared to pasireotide in preventing pancreatic surgery complications.
    Protection of trial subjects
    Both studied drugs have been used to reduce complications after pancreatic surgery. Complications after pancretic surgery are abundant and cause major morbidity and even mortality. The side effects these study drugs have are nausea and elevation of blood sugar levels for pasireotide and symphatic overexcitement for hydrocortisone. These side effects were registered and treated with antiemetics and insulin. Also, if an allergic reaction was noted, the study drug was prematurerly stopped. However, the possible side effects of these study drugs cause far less morbidity than the actual complications after pancreatic surgery.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 May 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy, Scientific research
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 168
    Worldwide total number of subjects
    168
    EEA total number of subjects
    168
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    75
    From 65 to 84 years
    93
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited between 19th of May 2016 and 17th of December 2018. All patients were treated in the Helsinki University Hospital, Helsinki Finland. Only patient in a high risk for postoperative pancreatic fistula were recruited. 42 patients out of 168 were excluded due to intraoperative findings indicating a low risk for fistula.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 168
    Number of subjects completed
    		 126

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 non eligible: 42
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Data analyst, Subject
    Blinding implementation details
    The randomization sequence was generated using a computer algorithm with randomly variable block size (2, 4, and 6). The randomization sequence was concealed in opaque and numbered envelopes.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Pasireotide
    Arm description
    		 Patients who received perioperative pasierotide
    Arm type
    		 Active comparator

    Investigational medicinal product name
    pasireotide
    Investigational medicinal product code
    Other name
    signifor
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    900 micrograms twice a day starting the morning of surgery until the sixth postoperative day. 14 doses in total.

    Arm title
    		 Hydrocortisone
    Arm description
    		 Patients who received perioperative hydrocortisone
    Arm type
    		 Experimental

    Investigational medicinal product name
    Hydrocrotisone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for dispersion for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    100 mg, intravenously 3 times a day, starting on the morning of the operation and continuing until the evening dose on postoperative day 2 (9 doses)

    Number of subjects in period 1 [1]
    		Pasireotide Hydrocortisone
    Started
    63
    63
    Completed
    63
    63
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 168 patients enrolled but 42 patients were intraoperatively excluded since they either did not under go a pancreatic resection (i.e. disseminated cancer at laparoscopy) or they were found to have low risk pancreas (i.e. firm pancreas or wide pancreatic duct). All these features are impossible to determine pre operatively but the study drug need to be started preoperatively. Thus some patients are excluded after the randomization.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pasireotide
    Reporting group description
    		 Patients who received perioperative pasierotide

    Reporting group title
    Hydrocortisone
    Reporting group description
    		 Patients who received perioperative hydrocortisone

    Reporting group values
    		 Pasireotide Hydrocortisone Total
    Number of subjects
    		 63 63 126
    Age categorical
    Units: Subjects
        Adults (18 and over)
    		 63 63 126
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 64 (56 to 70) 67 (56 to 73) -
    Gender categorical
    Units: Subjects
        Female
    		 28 38 66
        Male
    		 35 25 60
    ASA physical status
    Units: Subjects
        ASA 1
    		 2 2 4
        ASA 2
    		 30 29 59
        ASA 3
    		 29 29 58
        ASA 4
    		 2 3 5
    Charslon Comorbidity Index
    Units: Subjects
        Mild (0-2)
    		 45 37 82
        Moderate (3-4)
    		 15 18 33
        Severe (over 5)
    		 3 8 11
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 27.3 ( 3.6 ) 26.8 ( 4.3 ) -
    Subject analysis sets

    Subject analysis set title
    Baseline characateristics
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Patients with a high risk for postoperative pancreatic fistula continued the study drug after the operation. 63 patients in each arm (126 in total) continued the study drug. 42 of the 168 randomized patients were excluded intraoperatively since they were found to have a low risk for fistula or no pancreatic resection was made.

    Subject analysis sets values
    		 Baseline characateristics
    Number of subjects
    126
    Age categorical
    Units: Subjects
        Adults (18 and over)
    126
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    66 (56 to 72)
    Gender categorical
    Units: Subjects
        Female
    66
        Male
    60
    ASA physical status
    Units: Subjects
        ASA 1
    4
        ASA 2
    59
        ASA 3
    58
        ASA 4
    5
    Charslon Comorbidity Index
    Units: Subjects
        Mild (0-2)
    82
        Moderate (3-4)
    33
        Severe (over 5)
    11
    BMI
    Units: kg/m2
        arithmetic mean (standard deviation)
    27.1 ( 4.0 )

    End points

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    End points reporting groups
    Reporting group title
    Pasireotide
    Reporting group description
    		 Patients who received perioperative pasierotide

    Reporting group title
    Hydrocortisone
    Reporting group description
    		 Patients who received perioperative hydrocortisone

    Subject analysis set title
    Baseline characateristics
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    Patients with a high risk for postoperative pancreatic fistula continued the study drug after the operation. 63 patients in each arm (126 in total) continued the study drug. 42 of the 168 randomized patients were excluded intraoperatively since they were found to have a low risk for fistula or no pancreatic resection was made.

    Primary: Comprehensive complication index

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    End point title
    		 Comprehensive complication index
    End point description
    End point type
    Primary
    End point timeframe
    For the first 30 postoperative days
    End point values
    		 Pasireotide Hydrocortisone
    Number of subjects analysed
    63
    63
    Units: CCI
        number (not applicable)
    23.94
    30.11
    Statistical analysis title
    		 CCI
    Comparison groups
    Pasireotide v Hydrocortisone
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Odds ratio (OR)
    Confidence interval

    Secondary: CD 2 or more

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    End point title
    		 CD 2 or more
    End point description
    Clavien-Dindo complication 2 or more
    End point type
    Secondary
    End point timeframe
    First 30 PODs
    End point values
    		 Pasireotide Hydrocortisone
    Number of subjects analysed
    63
    63
    Units: n
        yes
    43
    44
        no
    20
    19
    Statistical analysis title
    		 CD 2 or more
    Comparison groups
    Pasireotide v Hydrocortisone
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: POPF

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    End point title
    		 POPF
    End point description
    Post operative pancreatic fistula
    End point type
    Secondary
    End point timeframe
    30 PODs
    End point values
    		 Pasireotide Hydrocortisone
    Number of subjects analysed
    63
    63
    Units: n
        yes
    34
    39
        no
    29
    24
    Statistical analysis title
    		 POPF
    Comparison groups
    Pasireotide v Hydrocortisone
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: DGE

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    End point title
    		 DGE
    End point description
    End point type
    Secondary
    End point timeframe
    30 PODs
    End point values
    		 Pasireotide Hydrocortisone
    Number of subjects analysed
    63
    63
    Units: n
        yes
    12
    19
        no
    51
    44
    Statistical analysis title
    		 dge
    Comparison groups
    Pasireotide v Hydrocortisone
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: PPH

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    End point title
    		 PPH
    End point description
    End point type
    Secondary
    End point timeframe
    30 PODs
    End point values
    		 Pasireotide Hydrocortisone
    Number of subjects analysed
    63
    63
    Units: n
        yes
    0
    7
        no
    63
    56
    Statistical analysis title
    		 pph
    Comparison groups
    Pasireotide v Hydrocortisone
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Chi-squared
    Confidence interval

    Secondary: LOS

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    End point title
    		 LOS
    End point description
    End point type
    Secondary
    End point timeframe
    Length of stay
    End point values
    		 Pasireotide Hydrocortisone
    Number of subjects analysed
    63
    63
    Units: days
        median (inter-quartile range (Q1-Q3))
    8 (7 to 13)
    10 (6 to 13.5)
    Statistical analysis title
    		 LOS
    Comparison groups
    Pasireotide v Hydrocortisone
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 > 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Odds ratio (OR)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -

    Secondary: Adjuvant chemo

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    End point title
    		 Adjuvant chemo
    End point description
    End point type
    Secondary
    End point timeframe
    Adjuvant chemo if needed for cancer patients
    End point values
    		 Pasireotide Hydrocortisone
    Number of subjects analysed
    26
    24
    Units: n
        yes
    20
    17
        no
    6
    7
    Statistical analysis title
    		 adjuvant chemo
    Comparison groups
    Pasireotide v Hydrocortisone
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Chi-squared
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First 30 post operative days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD-10
    Dictionary version
    2019
    Reporting groups
    Reporting group title
    Pasireotide
    Reporting group description
    		 Patients who received pasireotide

    Reporting group title
    Hydrocortisone
    Reporting group description
    		 Patients who received hydrocortisone

    Serious adverse events
    		 Pasireotide Hydrocortisone
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 63 (0.00%)
         number of deaths (all causes)
    1
    2
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pasireotide Hydrocortisone
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 63 (9.52%)
    1 / 63 (1.59%)
    Immune system disorders
    Allergic reaction to excipient
    Additional description: Allergic reaction to pasierotide
         subjects affected / exposed
    1 / 63 (1.59%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 63 (7.94%)
    1 / 63 (1.59%)
         occurrences all number
    5
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32022887
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