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    Summary
    EudraCT Number:2018-001778-12
    Sponsor's Protocol Code Number:HUGTP-CIR-FIBRIN-GLUE-01
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-05-17
    Trial 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 ConcernedSpain - AEMPS
    A.2EudraCT number2018-001778-12
    A.3Full title of the trial
    USE OF A FIBRINE ADHESIVE TO REDUCE THE DEHISCENCE OF ESOFAGOYEYUNAL ANASTOMOSIS IN TOTAL GASTRECTOMIES BY CANCER: RANDOMIZED AND MULTICENTRIC STUDY.
    UTILIZACIÓN DE UN ADHESIVO DE FIBRINA PARA DISMINUIR LA DEHISCENCIA DE LA ANASTOMOSIS ESOFAGOYEYUNAL EN GASTRECTOMIAS TOTALES POR CÁNCER: ESTUDIO ALEATORIZADO Y MULTICÉNTRICO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    THE ROLE OF A FIBRIN BASED GLUE TO REDUCE DEHISCENCE IN ESOPHAGOJEJUNAL ANASTOMOSIS
    EL PAPEL DE UN PEGAMENTO A BASE DE FIBRINA PARA REDUCIR LA DESHISCENCIA EN LA ANASTOMOSIS ESOFAGOJEJUNAL
    A.3.2Name or abbreviated title of the trial where available
    Use of fibrin adhesive in anastomosis
    Uso de adhesivo de fibrina en anastomosis
    A.4.1Sponsor's protocol code numberHUGTP-CIR-FIBRIN-GLUE-01
    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 SponsorFundació Institut de Recerca en Ciències de la Salut Germans Trias i Pujol
    B.1.3.4CountrySpain
    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 supportBaxter Co
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Institut d'investigació en Ciències de la Salut germans Trias i Pujol
    B.5.2Functional name of contact pointServicio de Cirugía General
    B.5.3 Address:
    B.5.3.1Street AddressCarretera de Canyet s/n
    B.5.3.2Town/ cityBadalona
    B.5.3.3Post code08916
    B.5.3.4CountrySpain
    B.5.4Telephone number34934651200
    B.5.5Fax number34934978843
    B.5.6E-mailsarasenti1010@gmail.com
    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 TISSEEL
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.1Product nameTISSEEL
    D.3.4Pharmaceutical form Sealant powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN THROMBIN
    D.3.9.1CAS number 9002-04-4
    D.3.9.3Other descriptive nameHUMAN THROMBIN
    D.3.9.4EV Substance CodeSUB20551
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 dehiscence of the esophagojejunal anastomosis after a total gastrectomy in patients with gastric adenocarcinoma
    La dehiscencia de la anastomosis esofagoyeyunal después de una gastrectomía total en pacientes con adenocarcinoma gástrico
    E.1.1.1Medical condition in easily understood language
    Leakage of the esophagojejunal anastomosis in patients who underwent a total gastrectomy due to gastric adenocarcinoma
    Fuga de la anastomosis esofagoyeyunal en pacientes sometidos a una gastrectomía total por adenocarcinoma gástrico
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10058439
    E.1.2Term Esophageal anastomosis
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10013121
    E.1.2Term Diseases of esophagus
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10075515
    E.1.2Term Stoma site leakage
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effectiveness of a fibrin-based tissue adhesive (Tisseal) to reduce the incidence of dehiscence in esophagojejunal anastomoses in total gastrectomies due to cancer.
    Evaluar la eficacia de un adhesivo tisular a base de fibrina (Tisseal) para disminuir la incidencia de dehiscencia en las anastomosis esófagoyeyunales en las gastrectomías totales por cáncer.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients of both sexes older than 18 years.
    - Diagnosis of gastric adenocarcinoma with the possibility of total gastrectomy with curative intention.
    - Patients with reference centers in the participating autonomies.
    - Understand and accept the trial procedures and sign an informed consent.
    - Pacientes de ambos sexos mayores de 18 años.
    - Diagnóstico de adenocarcinoma gástrico con posibilidad de gastrectomía total con intención curativa.
    - Pacientes con centros de referencia en las autonomías participantes.
    - Comprender y aceptar los procedimientos del ensayo y firmar un consentimiento informado.
    E.4Principal exclusion criteria
    - Failure to meet the inclusion criteria.
    - Diagnosis of non-epithelial neoplasia, metastasis, patients with unresected tumor or undergoing palliative resections.
    - Subjects who have intolerance or have presented serious adverse reactions to products formed with a fibrin adhesive.
    - Pregnant or lactating women
    - Subjects who are not able to understand the nature of the essay and the procedures that they are asked to follow.
    - Do not sign informed consent.
    - No cumplir los criterios de inclusión.
    - Diagnóstico de neoplasia no epitelial, metástasis, pacientes con tumor no resecado o sometidos a resecciones paliativas.
    - Sujetos que presenten intolerancia o hayan presentado reacciones adversas graves a los productos formados a base de adhesivo de fibrina.
    - Mujeres embarazadas o lactantes
    - Sujetos que no sean capaces de entender la naturaleza del ensayo y los procedimientos que se les solicita seguir.
    - No firmar el consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    Dehiscence of suture diagnosed in the postoperative period using clinical and / or radiological parameters. Classification of Csendes
    Dehiscencia de sutura diagnosticada en el postoperatorio mediante parámetros clínicos y/o radiológicos. Clasificación de Csendes
    E.5.1.1Timepoint(s) of evaluation of this end point
    A week of follow-up (after surgery)
    Una semana de seguimiento (después de la cirugía)
    E.5.2Secondary end point(s)
    - Type of anastomosis performed: manual, mechanical (circular or linear)
    - Amylases in drainage on days 1,3,5,7 postoperatively or until drainage is withdrawn.
    - Leukocytes, procalcitonin, C-reactive protein in blood on days 0,1,3,5,7 postoperatively.
    - CT realization day with oral contrast. Findings of the TC according to the Goense score
    - Postoperative complication and type (Classification of Clavien Dindo)
    - Need for urgent surgical re-intervention
    - In-hospital and 90-day mortality
    - Date of hospital discharge
    - Re-entries at 30 and 90 days
    - Tipo de anastomosis realizada: manual, mecánica (circular o lineal)
    - Amilasas en drenaje en los días 1,3,5,7 postoperatorio o hasta la retirada del drenaje.
    - Leucocitos, procalcitonina, proteina C reactiva en sangre los días 0,1,3,5,7 postoperatorio.
    - Día de realización de la TC con contraste oral. Hallazgos de la TC según score Goense
    - Complicación postoperatoria y tipo (Clasificación de Clavien Dindo)
    - Necesidad de re-intervención quirúrgica urgente
    - Mortalidad intrahospitalaria y a los 90 días
    - Fecha de alta hospitalaria
    - Reingresos a los 30 y 90 días
    E.5.2.1Timepoint(s) of evaluation of this end point
    A follow-up of 90 days after surgery
    Seguimiento de 90 días tras la cirugía
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.1.4Double blind No
    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
    Grupo no intervención
    Non interventional group
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    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 No
    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 clinical trial will be considered completed after the full participation of the intended subjects to obtain the necessary data.
    It can be interrupted in the following cases:
    - Adverse events
    - Intercurrent diseases that may influence the results or health of volunteers
    - Concomitant medication or non-compliance by the subjects that may influence the results or the health of the volunteers
    - Cancellation by the developer
    El ensayo clínico se considerará finalizado tras la participación completa de los sujetos previstos para obtener los datos necesarios.
    Puede ser interrumpido en los siguientes supuestos:
    - Acontecimientos adversos
    - Enfermedades intercurrentes que puedan influir en los resultados o la salud de los voluntarios
    - Medicación concomitante o incumplimiento por parte de los sujetos que pueda influir en los resultados o la salud de los voluntarios
    - Cancelación por parte del promotor
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    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: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    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 state250
    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
    N
    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 Decision2019-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-08
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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