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    Summary
    EudraCT Number:2014-002036-14
    Sponsor's Protocol Code Number:V3.10.5.2014
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-06-16
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2014-002036-14
    A.3Full title of the trial
    The effect of epidural anaesthesia on systemic and splanchnic hemodynamic during gastroesophageal resections, a randomized controlled trial
    Effekt af epidural anæstesi på systemisk og splanknisk hæmodynamik under esophagusresektion, et randomiseret kontrolleret studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of epidural anaesthesia on systemic and local blood flow during stomach cancer operation
    Effekt af epidural bedøvelse på systemisk og lokal blodgennemstrømning under operation for mavemundscancer
    A.3.2Name or abbreviated title of the trial where available
    The effect of epidural anaesthesia on blood flow
    Effekt af epidural bedøvelse på blodgennemstrømning
    A.4.1Sponsor's protocol code numberV3.10.5.2014
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLars Bo Svendsen
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportThe Danish Cancer Society
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Surgical Gastroenterology, Rigshospitalet
    B.5.2Functional name of contact pointRikard Bien Ambrus
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen Ø
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number004560677929
    B.5.6E-mailrikard.bien.ambrus.02@regionh.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Lidokain-adrenalin SAD.
    D.2.1.1.2Name of the Marketing Authorisation holderAmgros I/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEpidural use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIDOCAINE HYDROCHLORIDE
    D.3.9.3Other descriptive namelidocain
    D.3.9.4EV Substance CodeSUB88133
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNOREPINEPHRINE BITARTRATE
    D.3.9.1CAS number 51-40-1
    D.3.9.3Other descriptive nameandrenaline
    D.3.9.4EV Substance CodeSUB03455MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Bupivacain SAD
    D.2.1.1.2Name of the Marketing Authorisation holderAmgros I/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEpidural use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbupivacaine
    D.3.9.3Other descriptive nameBUPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB00902MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Bupivacain-morfin SAD
    D.2.1.1.2Name of the Marketing Authorisation holderAmgros I/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEpidural use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmorphine
    D.3.9.1CAS number 52-26-6
    D.3.9.3Other descriptive nameMORPHINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB14596MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNbupivacaine
    D.3.9.3Other descriptive nameBUPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB00902MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The effect of epidural anaesthesia on systemic and splanchnic hemodynamic during gastroesophageal cancer resection
    Effekt af epidural anæstesi på systemisk og splanknisk hæmodynamik under esophagusresektion
    E.1.1.1Medical condition in easily understood language
    The effect of epidural anaesthesia on systemic and local blood flow during stomach cancer operation
    Effekt af epidural bedøvelse på systemisk og lokal blodgennemstrømning under operation for mavemundscancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10066354
    E.1.2Term Adenocarcinoma of the gastroesophageal junction
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Epidural anaesthesia reduces the sympathetic response, thereby possibly inhibiting the microcirculation in the splanchnic system, especially in the gastric conduit. With this study, we wish to evaluate hemodynamic fluctuations and gastric circulation as well as vasodilatory substances (e.g. PGI2) in relevant intervals from the activation of epidural analgesia.

    The hypothesis is that epidural analgesia reduces sympathetic nerve activity and thereby inhibiting the splanhcnic microcirculation, especially in the gastric conduit. Late activation of epidural analgesia is believed to be more advantageous.
    Epidural anæstesi reducerer det systemiske response hvilket kan reducere microcirkulationen i splanchnicus, specielt i det gastriske konduit. Formålet med studiet er at vurdere de hæmodynamiske fluktuationer, microcrokulationen i det gastriske konduit, samt ændringer i de vasoaktive stoffers koncentrationer efter aktivering af epidural anæstesi.

    Hypotesen er at epidural analgesi sænker sympatisk nerveaktivitet og hæmmer dermed microcirkulationen i splanchnicus og specielt i ventrikelrøret, hvorfor sen aktivering af epidural analgesi er fordelagtigt.
    E.2.2Secondary objectives of the trial
    The secondary objective is to investigate the surgical stress response during and after surgery and the rate of postoperative complications, such as anstomotic leakage, infections, and pulmonary complications, in relation with early or late activation of epidural anaesthesia.
    Det sekundære formål er at undersøge det kirurgiske stress-response under og efter kirurgi og forekomsten af ​​postoperative komplikationer, såsom anstomose lækage, infektioner og pulmonale komplikationer i forbindelse med tidlig versus sen aktivering af epidural anæstesi.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patiens over 18 years of age planned for gastroesophageal resection due to adenocarcinoma of the gastroesophageal junction.
    No discriminations of ethnic or gender.
    Voksne (>18 år) og myndige patienter, der skal undergå åben esophagusresektion for biopsiverificeret adenocarcinom. Ingen krav til etnicitet eller køn.

    E.4Principal exclusion criteria
    Lack of consent.
    Patients planned for robot-assisted surgery.
    Manglende samtykke.
    Patienter der skal gennemgå robot-assisterede operationer
    E.5 End points
    E.5.1Primary end point(s)
    Significant alterations in microcirculation in the gastric conduit related to early versus late activation of epidural anaesthesia.

    The study will be stopped when 50 patients have been randomised to early or late activation af epidural anaesthesia during surgery.
    Signifikante ændringer i mikrocirkulationen i det gastriske konduit, relateret til tidlig versus sen aktivering af epidural anæstesi.

    Undersøgelsen stoppes, når 50 patienter er blevet randomiseret til tidlig eller sen aktivering of epidural anæstesi under operation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The first evaluation will be made when 20 patients have been included. During the study period, interim-analyzes will be made every sixth months until 50 patients have been included.
    Den første interimanalyse foretages når 20 patienter er inkluderet. I løbet af undersøgelses perioden foretages interimanalyser hver sjette måned indtil 50 patienter er inkluderet.
    E.5.2Secondary end point(s)
    Significant differences of intra- and postoperative levels of surgical response between the groups, defined as alterations in serum cortisol, aldosterone, adrenaline, noradrenaline, and ACTH.

    Significant alterations in the plasmalevels og atrial natriuretic hormon (ANP), prostacyclin and GLP-1

    Significant differences in the rate of postoperative complications between the groups, such as anastomotic leakage, infections, pulmonary complications, and death.



    Signifikante forskelle i intra- og postoperative niveauer af kirurgisk stress response mellem grupperne , defineret som ændringer i cortisol, aldosteron, adrenalin, noradrenalin og ACTH.

    Signifikante ændringer i plasmaniveauer af atrial natriuretisk hormon (ANP), prostacyclin og GLP-1

    Signifikante forskelle i antallet af postoperative komplikationer mellem grupperne, såsom anastomotisk lækage, infektioner, pulmonale komplikationer og død.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The first evaluation will be made when 20 patients have been included. During the study period, interim-analyzes will be made every sixth months until 50 patients have been included.
    Den første interimanalyse foretages når 20 patienter er inkluderet. I løbet af undersøgelses perioden foretages interimanalyser hver sjette måned indtil 50 patienter er inkluderet.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Early versus Late activation of epidura anaesthesia. No other medicinal products will de used
    The effect of epidural anaesthesia is compared between a early and late activation.
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The study will be stopped if there the rate of anastomotic leakage is over 15 % at the interim-analyzes. If the high leakage-rate is due to time of activation of epidural anaesthesia, the study will be stopped permanently.

    Also, the study will bee stopped at the occurence of a Serious Adverse Event/Suspected Unexpected Serious Adverse Reaction, related to the time of activation of epidural anaesthesia.
    Forsøget stoppes hvis der ses en lækage-rate over 15 % ved interimanalyser. Såfremt konklusionen skulle være, at den høje lækage-rate skulle være forårsaget af sen aktivering af epidural analgesi, afsluttes forsøget med det samme.

    Forsøget stoppes hvis en Serious Adverse Event/Suspected Unexpected Serious Adverse Reaction kan relateres til tidlig aktivering af epidural anæstesi.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-06-16. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ingen
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-30
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