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    Summary
    EudraCT Number:2020-006001-35
    Sponsor's Protocol Code Number:PREBOT-II
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-01
    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 ConcernedGermany - BfArM
    A.2EudraCT number2020-006001-35
    A.3Full title of the trial
    Randomized controlled trial of PREoperative injection of BOTulinum toxin into the sphincter of Oddi to reduce bile leakage after hepatic resection
    PREBOT-II
    Randomisiert-kontrollierte Studie zur präoperativen Injektion von Botulinumtoxin in den Sphinkter Oddi zur Reduktion der postoperativen Galleleckage nach Leberresektion
    PREBOT-II
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial investigating an endoscopic procedure with the aim to reduce
    the most frequent and potentially life-threatening complication in patients
    undergoing liver resection
    Klinische Studie mit einer endoskopischen Untersuchung zur Reduktion der häufigsten und potentiell
    lebensbedrohlichen Komplikation nach einer Operation an der Leber
    A.3.2Name or abbreviated title of the trial where available
    PREBOT-II
    PREBOT-II
    A.4.1Sponsor's protocol code numberPREBOT-II
    A.5.4Other Identifiers
    Name:German Clinical Trials RegisterNumber:DRKS00024061
    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 SponsorUniversity Hospital Heidelberg
    B.1.3.4CountryGermany
    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 supportFederal Ministry of Education and Research (BMBF)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStudy Center of the German Surgical Society (SDGC)
    B.5.2Functional name of contact pointSDGC
    B.5.3 Address:
    B.5.3.1Street AddressMarsilius-Arkaden, Im Neuenheimer Feld 130.3
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69120
    B.5.3.4CountryGermany
    B.5.4Telephone number496221566980
    B.5.5Fax number4862215633850
    B.5.6E-mailsdgc@med.uni-heidelberg.de
    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 BOTOX
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClostridium botulinum Toxin Typ A
    D.3.9.1CAS number 93384-43-1
    D.3.9.3Other descriptive nameBOTULINUM TOXIN TYPE A
    D.3.9.4EV Substance CodeSUB13117MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    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
    Patients undergoing partial hepatic resection for various underlying diseases.
    Patienten, die an einer Grunderkrankung leiden, die durch eine Leberteilresektion ohne biliäre Rekonstruktion behandelt werden sollen.
    E.1.1.1Medical condition in easily understood language
    Elective resection of a part of the liver for any underlying disease.
    Geplante Entfernung eines Teils der Leber zur operativen Behandlung unterschiedlicher Lebererkrankungen.
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10077348
    E.1.2Term Liver resection
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The PREBOT II trial is a multicentre, randomised controlled phase II clinical trial with two parallel study
    arms. The primary objective of this pilot trial is to investigate the benefit of an endoscopic injection of
    botulinum toxin into the sphincter Oddi prior to planned partial liver resection to reduce postoperative bile leakage. The main focus is on testing the safety and feasibility of the procedure, but first data on its
    effectiveness will also be gained.
    Bei der PREBOT-II-Studie handelt es sich um eine multizentrische, randomisiert-kontrollierte, klinische
    Studie der Phase II mit zwei parallelen Studienarmen. Primäres Ziel dieser Pilotstudie ist es, den Nutzen
    einer endoskopischen Injektion von Botulinumtoxin in den Sphinkter Oddi vor geplanter Leberteilresektion zur Reduktion der postoperativen Galleleckage zu untersuchen. Im Vordergrund steht hierbei die Überprüfung der Sicherheit und Machbarkeit des Verfahrens, es sollen aber auch erste Daten zur Wirksamkeit erhoben werden.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate clinically relevant postinterventional and postoperative complications in intervention and control group: Severity of bile leakage according to the ISGLS, occurrence of post-interventional pancreatitis, post-hepatectomy liver failure according to the ISGLS, postoperative overall morbidity ( including post-hepatectomy hemorrhage according to the ISGLS, intra-abdominal fluid collection/abscess, perioperative sepsis, etc.) and severity of listed postoperative complications according to the Clavien-Dindo classification, reinterventions/-operations, mortality, quality of life using the Short Form (SF)-12 Health Survey, intensive/intermediate care unit stay, total hospital stay, readmission to hospital
    Sekundäres Ziel ist die Untersuchung von klinisch relevanten Komplikationen nach der Intervention bzw. Operation in der Interventions- und Kontrollgruppe: Schweregrad der Galleleckage (gemäß den Richtlinien der ISGLS), das Auftreten einer postinterventionellen Pankreatitis oder von Leberversagen (gemäß den Richtlinien der ISGLS) nach Leberresektion, die Gesamtmorbidität beinhaltend Blutungen nach Leberresektion (gemäß den Richtlinien der ISGLS), intraabdominelle Flüssigkeitsansammlungen und Abszesse und die perioperative Sepsis, sowie die Schwere der postoperativen Komplikationen (gemäß der Clavien-Dindo Klassifikation), Reinterventionen und Reoperationen, die Mortalität, Die Lebensqualität unter Verwendung des Short Form (SF)-Health Survey Fragebogens, die Dauer der Intensiv/Intermediate Care Aufenthaltes, die Gesamtdauer des Krankenhausaufenthaltes und die Wiederaufnahme ins Krankenhaus.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria
    – Patients scheduled for elective, primary hepatic resection with no planned biliary reconstruction
    – Male or female patients ≥18 years of age
    – Ability of patient to understand character and individual consequences of the clinical trial
    – Written informed consent (available before enrollment)
    – For women with childbearing potential, presence of negative urine or blood pregnancy test, and adequate contraception until 14 days after trial intervention
    Einschlusskriterien
    -Patienten, die für eine primäre Leberresektion ohne biliäre Rekonstruktion geplant sind
    -Männliche oder weibliche Patienten, die 18 Jahre oder älter sind
    -Fähigkeit des Patienten, den Charakter und die individuellen Konsequenzen der klinischen Studie zu erfassen
    -schriftliche Einverständniserklärung (zur Verfügung stehend vor dem Einschluss)
    -Bei Frauen im gebärfähigen Alter Vorliegen eines negativen Schwangerschaftstestes aus Blut oder Urin sowie Durchführung einer adäquaten Kontrazeption bis 14 Tage nach der Studienintervention
    E.4Principal exclusion criteria
    – Patients who already underwent papillotomy for any reason or have an inlaying bile stent
    – Serious cardiovascular disease (e.g. myocardial infarction in the last 12 months, congestive heart failure NYHA III/IV, unstable angina pectoris)
    – Serious renal insufficiency, i.e. creatinine clearance <30 mL/min (estimated by Cockcroft-Gault)
    – Liver cirrhosis (Child B/C)
    – American Society of Anesthesiologists (ASA) score >III
    – Hypersensitivity to any BTX preparation or to any of the components in the formulation
    – Neuromuscular disorder, e.g. peripheral motor neuropathic disease, amyotrophic lateral sclerosis or neuromuscular junction disorders (e.g. myasthenia gravis or Lambert-Eaton syndrome), or any other neurological disorder with associated increased risk for the patient undergoing BTX injection
    – Any condition in which duodenoscopy and/or the trial intervention is not possible, e.g. for anatomical reasons, or obsolete in the actual situation, e.g. in patients with acute pancreatitis
    – History of BTX application
    – Understanding or language problems
    – Inability to comply with study and/or follow-up procedures
    – Pregnancy or lactation
    – Concurrent participation in another interventional clinical trial
    – Any condition or situation which could result in an undue risk for the patient and/or influence outcome measures in the opinion of the investigator
    -Patienten, die bereits eine Papillotomie erhalten haben oder einen einliegenden Gallengangsstent haben
    -Schwere kardiovaskuläre Erkrankung (z.B. Herzinfarkt innerhalb der letzten 12 Monate, Herzinsuffizienz nach den NYHA Kriterien Grad III/IV, instabile Angina pectoris)
    -Schwere Niereninsuffizienz mit einer Kreatinin-Clearance <30ml/min (geschätzt nach Cockcroft-Gault)
    -Leberzirrhose (Child B/C)
    -American Society of Anesthesiologists (ASA) Score > III
    -Überempfindlichkeit/allergische Reaktion auf Botulinumtoxin oder einen der Inhaltsstoffe der Lösung
    -Neuromuskuläre Erkrankungen, (z.B. Myasthenia gravis oder Lambert-Eaton Syndrom) oder andere neurologische Erkrankungen die mit einem erhöhten Risiko der Botulinumtoxininjektion für den Patienten einhergehen
    -Jede Bedingung, die eine Duodenoskopie oder die Studienintervention nicht möglich macht, z.B. anatomische Gründe oder obsolete aktuelle Situation z.B. auf Grund einer akuten Pankreatitis
    -Applikation von Botulinumtoxin in der Vergangenheit
    -Verständnisprobleme, auch basierend auf einer sprachlichen Barriere
    -Fehlende Compliance für die Teilnahme an der Studie sowie deren Follow up
    -Schwangerschaft und Stillzeit
    -Teilnahme an einer anderen interventionellen klinischen Studie
    -Jede Konstitution oder Situation, die nach Maßgabe des Studienarztes mit einem erhöhten Risiko für den Patienten verbunden sein kann und/oder das Ergebnis der Endpunkte der Studie beeinflussen kann
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of postoperative bile leakage within 30 days after hepatic resection according to the definition of the International Study Group of Liver Surgery (ISGLS).
    Auftreten einer postoperativen Galleleckage (gemäß den Richtlinien der ISGLS) innerhalb von 30 Tagen nach der Operation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 4: (3 days after operation) POD = post-operative day
    Visit 5: (day of hospital discharge)
    Visit 6: POD 30
    Visit 7: 3 months after index operation
    Visite 4: (3 Tage nach der Operation) POD = post-operative day (=postoperativer Tag)
    Visite 5: (Tag der Entlassung aus dem Krankenhaus)
    Visite 6: POD 30
    Visite 7: 3 Monate nach der Operation
    E.5.2Secondary end point(s)
    Severity of bile leakage according to the ISGLS, occurrence of post-interventional pancreatitis, post-hepatectomy liver failure according to the ISGLS, postoperative overall morbidity ( including post-hepatectomy hemorrhage according to the ISGLS, intra-abdominal fluid collection/abscess, perioperative sepsis, etc.) and severity of listed postoperative complications according to the Clavien-Dindo classification, reinterventions/-operations, mortality, quality of life using the Short Form (SF)-12 Health Survey, intensive/intermediate care unit stay, total hospital stay, readmission to hospital
    Schweregrad der Galleleckage (gemäß den Richtlinien der ISGLS), das Auftreten einer postinterventionellen Pankreatitis oder von Leberversagen (gemäß den Richtlinien der ISGLS) nach Leberresektion, die Gesamtmorbidität beinhaltend Blutungen nach Leberresektion (gemäß den Richtlinien der ISGLS), intraabdominelle Flüssigkeitsansammlungen und Abszesse und die perioperative Sepsis, sowie die Schwere der postoperativen Komplikationen (gemäß der Clavien-Dindo Klassifikation), Reinterventionen und Reoperationen, die Mortalität, Die Lebensqualität unter Verwendung des Short Form (SF)-Health Survey Fragebogens, die Dauer der Intensiv/Intermediate Care Aufenthaltes, die Gesamtdauer des Krankenhausaufenthaltes und die Wiederaufnahme ins Krankenhaus.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints are assessed during study visits on postoperative day (POD) 3, day of discharge, POD 30 and 3 months after the index operation.
    Die sekundären Endpunkte werden durch Studienvisiten am 3. postoperativen Tag, am Tag der Entlassung aus dem Krankenhaus, am 30. postoperativen Tag und 3 Monate nach der Indexoperation erfasst.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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
    Keine präoperative Intervention (Endoskopie mit Botoxinjektion)
    No preoperative intervention (endoscopy with injection of Botox)
    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 concerned3
    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
    LVLS
    Letzte Visite des letzten Patienten.
    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 months0
    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: 45
    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 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 state70
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 70
    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)
    The treatment after the patient has ended the participation is not different from the expected normal treatment of the underlying diseases.
    Die Behandlung des Patienten nach Studienende entspricht der Standardbehandlung der zugrunde liegenden Erkrankungen
    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 Decision2021-10-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-02
    P. End of Trial
    P.End of Trial StatusOngoing
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