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    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2022-000904-36
    Sponsor's Protocol Code Number:IBS-DOTIG-ECM-2202
    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:2022-03-18
    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 number2022-000904-36
    A.3Full title of the trial
    Randomized clinical trial to evaluate the dose and administration time of indocyanine green in near-infrared fluorescent cholangiography during laparoscopic cholecystectomy.
    Ensayo clínico aleatorizado para evaluar la dosis y el tiempo de administración del verde de indocianina en la colangiografía fluorescente por infrarrojo cercano durante la colecistectomía laparoscópica.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the dose and administration time of indocyanine green in fluorescent cholangiography during laparoscopic cholecystectomy.
    Ensayo clínico para evaluar la dosis y el tiempo de administración del verde de indocianina en la colangiografía fluorescente durante la colecistectomía laparoscópica.
    A.3.2Name or abbreviated title of the trial where available
    DOTIG Study
    Estudio DOTIG
    A.4.1Sponsor's protocol code numberIBS-DOTIG-ECM-2202
    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 SponsorInstituto de Investigación Biomédica de Salamanca
    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 supportInstituto de Investigación Biomédica de Salamanca
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUICEC IBSAL
    B.5.2Functional name of contact pointÁrea de Ensayos Clínicos
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de San Vicente
    B.5.3.2Town/ citySalamanca
    B.5.3.3Post code37007
    B.5.3.4CountrySpain
    B.5.4Telephone number00349232911005779
    B.5.6E-mailricardo.lopez@scren.es
    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 Verdye 25 mg polvo para solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderDiagnostic Green GmbH
    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.3.4Pharmaceutical form Powder for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Laparoscopic cholecystectomy.
    Colecistectomía laparoscópica
    E.1.1.1Medical condition in easily understood language
    Laparoscopic cholecystectomy.
    Colecistectomía laparoscópica
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10008611
    E.1.2Term Cholecystectomy
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    334 / 5.000
    Resultados de traducción
    The main objective of the study is to analyze whether there are differences between different types of doses and administration intervals of indocyanine green to obtain quality fluorescent cholangiography during laparoscopic cholecystectomy. In addition, the factors that influence the results of the technique will be sought.
    El objetivo principal del estudio es analizar si existen diferencias entre diferentes tipos de dosis e intervalos de administración del verde de indocianina para obtener una colangiografía fluorescente de calidad durante la colecistectomía laparoscópica. Además, se buscarán los factores que influyen en los resultados de la técnica.
    E.2.2Secondary objectives of the trial
    1.020 / 5.000
    Resultados de traducción
    1. To analyze the influence of the body mass index on the results of the CF during the LC.
    2. To analyze the influence of the type of biliary pathology secondary to surgery on the results of FC during LC.
    3. To analyze the influence of the type of surgery (elective/early) on the results of FC during LC.
    4. To analyze the influence of previous inflammatory changes on the results of FC during LC.
    5. To analyze the influence of prior gallbladder or bile duct instrumentation on the results of FC during LC.
    6. To analyze the influence of the different laparoscopic imaging systems on the results of FC during LC.
    7. To analyze the rate of intraoperative complications related to FC during LC.
    8. To analyze the rate of postoperative complications related to FC during LC.
    1. Analizar la influencia del índice de masa corporal en los resultados de la CF durante la CL.
    2. Analizar la influencia del tipo de patología biliar subsidiaria de cirugía en los resultados de la CF durante la CL.
    3. Analizar la influencia del tipo de cirugía (electiva/precoz) en los resultados de la CF durante la CL.
    4. Analizar la influencia de los cambios inflamatorios previos en los resultados de la CF durante la CL.
    5. Analizar la influencia de las instrumentaciones previas de la vesícula biliar o de la vía biliar en los resultados de la CF durante la CL.
    6. Analizar la influencia que presentan los diferentes sistemas de imagen laparoscópicos en los resultados de la CF durante la CL.
    7. Analizar la tasa de complicaciones intraoperatorias relacionadas con la CF durante la CL.
    8. Analizar la tasa de complicaciones postoperatorias relacionadas con la CF durante la CL.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age over 18 years.
    • Autonomy, self-sufficiency and independence.
    • Scheduled CL indication:
    - Symptomatic cholelithiasis: history of biliary colic, acute lithiasic cholecystitis, choledocholithiasis, acute ascending cholangitis of lithiasic origin or acute lithiasic pancreatitis.
    - Gallbladder polyps with indication for laparoscopic surgery.
    - Vesicular adenomyomatosis with indication for laparoscopic surgery.
    • Indication of early LC (<72 hours of admission for acute stone cholecystitis/acute acalculous cholecystitis/complicated biliary colic).
    • Deferred urgency LC indication.
    • Understanding of information.
    • Signature of the informed consent.
    • Edad mayor a 18 años.
    • Autonomía, autosuficiencia e independencia.
    • Indicación de CL programada:
    - Colelitiasis sintomática: antecedentes de cólicos biliares, colecistitis aguda litiásica, coledocolitiasis, colangitis aguda ascendente de origen litiásico o pancreatitis aguda litiásica.
    - Pólipos vesiculares con indicación de cirugía laparoscópica.
    - Adenomiomatosis vesicular con indicación de cirugía laparoscópica.
    • Indicación de CL precoz (<72 horas de ingreso por colecistitis aguda litiásica/colecistitis aguda alitiásica/cólico biliar complicado).
    • Indicación de CL de urgencia diferida.
    • Comprensión de la información.
    • Firma del consentimiento informado.
    E.4Principal exclusion criteria
    • Age less than 18 years.
    • Disability.
    • Pregnancy or lactation.
    • Chronic kidney disease (Stage > IIIb).
    • Previous adverse reactions or allergies to VI.
    • Previous adverse reactions or allergies to VI excipients.
    • Adverse reactions or confirmed allergies to iodinated contrast agents.
    • Functional thyroid pathology (hyperthyroidism, thyroiditis, toxic multinodular goiter, functioning thyroid adenoma).
    • Urgent non-deferrable/emergent gallbladder surgery.
    • Initial surgery by laparotomy.
    • Previous suspicion of gallbladder carcinoma.
    • Inability to understand the information needed to participate in the study.
    • Rejection of inclusion within the study protocol.
    • Edad menor a 18 años.
    • Incapacidad.
    • Embarazo o lactancia.
    • Enfermedad renal crónica (Estadio > IIIb).
    • Reacciones adversas o alergias previas al VI.
    • Reacciones adversas o alergias previas a excipientes del VI.
    • Reacciones adversas o alergias confirmadas a contrastes iodados.
    • Patología tiroidea funcional (hipertiroidismo, tiroiditis, bocio multinodular tóxico, adenoma tiroideo funcionante).
    • Cirugía urgente no diferible/emergente de la vesícula biliar.
    • Cirugía inicial por vía laparotómica.
    • Sospecha previa de carcinoma de vesícula biliar.
    • Incapacidad de comprender la información necesaria para participar en el estudio.
    • Rechazo de inclusión dentro del protocolo del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    • Identification of biliary structures prior to dissection of the hepatocystic triangle.
    • Identification of biliary structures after dissection of the hepatocystic triangle.
    • Identificación de estructuras biliares previas a la disección del triángulo hepatocístico.
    • Identificación de estructuras biliares posteriores a la disección del triángulo hepatocístico.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the time of the surgical procedure
    En el momento del procedimiento quirúrgico
    E.5.2Secondary end point(s)
    • Degree of identification of biliary structures prior to dissection of the hepatocystic triangle.
    • Degree of identification of biliary structures after dissection of the hepatocystic triangle.
    • Extent to which fluorescence cholangiography was perceived as useful for surgery
    • Extent to which liver fundus fluorescence (contrast between liver and ducts) was perceived as disturbingPlease enter information in English and add any other language that is applicable
    • Grado de identificación de estructuras biliares previas a la disección del triángulo hepatocístico
    • Grado de identificación de estructuras biliares posteriores a la disección del triángulo hepatocístico
    • Grado en el que la colangiografía por fluorescencia se percibía como útil para la cirugía
    • Grado en el que la fluorescencia del fondo del hígado (contraste entre hígado y conductos) se percibía como perturbador
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the time of the surgical procedure
    En el momento del procedimiento quirúrgico
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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 No
    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 concerned2
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state200
    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
    Ninguno
    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 Decision2022-05-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-30
    P. End of Trial
    P.End of Trial StatusOngoing
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