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    Summary
    EudraCT Number:2019-002461-35
    Sponsor's Protocol Code Number:PREBOTPilot
    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:2019-07-17
    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 ConcernedGermany - BfArM
    A.2EudraCT number2019-002461-35
    A.3Full title of the trial
    Monocenter, randomized, controlled, open-label, phase-II clinical trial of PREoperative endoscopic injection of BOTulinum toxin in the sphincter of Oddi to reduce postoperative pancreatic fistula after distal pancreatectomy (PREBOTPilot)
    Monozentrische, randomisierte, kontrollierte, offene, klinische Studie der Phase II zur Reduktion der postoperativen Pankreasfistel nach Pankreaslinksresektion durch eine präoperative endoskopische Injektion von Botulinumtoxin in den Sphinkter Oddi (PREBOTPilot)
    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 resection of the body and/or tail of the pancreas
    Klinische Studie zur Reduktion der häufigsten und potentiell lebensbedrohlichen Komplikation nach Entfernung des Körpers und/oder Schwanzes der Bauchspeicheldrüse durch ein endoskopisches Verfahren
    A.4.1Sponsor's protocol code numberPREBOTPilot
    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
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Heidelberg, Department of General, Visceral, and Transplantation Surgery
    B.5.2Functional name of contact pointClinical Project Management
    B.5.3 Address:
    B.5.3.1Street AddressIm Neuenheimer Feld 110
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69120
    B.5.3.4CountryGermany
    B.5.4Telephone number+4962215635242
    B.5.5Fax number+496221565969
    B.5.6E-mailUlla.Klaiber@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 Ireland
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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.3.9.1CAS 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.3.11 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
    Elective distal pancreatectomy for any underlying disease
    Geplante Pankreaslinksresektion zur operativen Behandlung
    unterschiedlicher Bauchspeicheldrüsenerkrankungen
    E.1.1.1Medical condition in easily understood language
    Elective resection of the body and/or tail of the pancreas for any
    underlying disease
    Geplante Entfernung des Körpers und/oder Schwanzes der
    Bauchspeicheldrüse zur operativen Behandlung unterschiedlicher
    Bauchspeicheldrüsenerkrankungen
    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 10013476
    E.1.2Term Distal pancreatectomy
    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 main purpose of this study is to evaluate the safety and feasibilty of a preoperative endoscopic injection of botulinum toxin into the sphincter of Oddi within 3-10 days before distal pancreatectomy to reduce clinically relevant pancreatic fistula (POPF) and/or death, and to gain preliminary efficacy data which will serve as a basis for a subsequent confirmatory trial. The primary endpoint is the occurrence of clinically relevant POPF and/or death due to any cause within 30 days after surgery. Clinically relevant POPF is defined as grade B and C fistulas according to the currently updated definition of the International Study Group of Pancreatic Surgery (ISGPS). Safety is evaluated by the assessment of adverse events (AE) and serious adverse events (SAE).
    In der vorliegenden Studie sollen primär die Sicherheit und Machbarkeit einer präoperativen Injektion von Botulinumtoxin in den Sphinkter Oddi innerhalb von 3-10 Tagen vor Pankreaslinksresektion untersucht werden, sowie erste randomisierte Daten zur Wirksamkeit der Studienintervention gewonnen werden. Primärer Endpunkt in Bezug auf die Wirksamkeit der Studienintervention ist das Auftreten einer klinisch relevanten Pankreasfistel (POPF Schweregrade B und C nach Konsensusdefinition der International Study Group of Pancreatic Surgery (ISGPS)) und/oder Tod innerhalb von 30 Tagen nach Pankreaslinksresektion. Die Sicherheit der Patienten wird durch Erfassung von Unerwünschten Ereignissen (Adverse Events, AE) und Schwerwiegenden Unerwünschten Ereignissen (Serious Adverse Events, SAE) überwacht.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate postinterventional and postoperative complications in intervention and control groups, i.e. the overall occurrence and severity of postoperative pancreatic Fistula (POPF) according to the International Study Group of Pancreatic Surgery (ISGPS), postinterventional pancreatitis, perioperative sepsis, delayed gastric emptying (DGE), postpancreatectomy hemorrhage (PPH), intraabdominal fluid collection/abscess, lymphatic fistula/chylus ascites, wound infection, burst abdomen, reinterventions/-operations, and overall mortality. Furthermore, quality of life, durations of intensive care unit/intermediate care unit stay and total hospital stay, and readmission due to postoperative complications will be evaluated.
    Sekundäres Ziel ist die Untersuchung von klinisch relevanten Komplikationen nach der Intervention bzw. Operation in der Interventions- und Kontrollgruppe. Dazu gehören die Gesamthäufigkeit und Häufigkeit der Schweregrade der postoperativen Pankreasfistel (POPF) nach Konsensusdefinition der International Study Group of Pancreatic Surgery (ISGPS), die postinterventionelle Pankreatitis, perioperative Sepsis, verzögerte Magenentleerung, Postpankreatektomieblutung, intraabdominelle Flüssigkeitskollektion/Abszess, Lymphfistel, Wundinfekt, Platzbauch, Reinterventionen/-operationen und Gesamtmortalität. Außerdem werden die Lebensqualität, die Dauer des Aufenthaltes auf der Intensivstation, die Gesamtaufenthaltsdauer im Krankenhaus und Wiederaufnahmen ins Krankenhaus aufgrund von postoperativen Komplikationen untersucht.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    – Patients scheduled for elective, primary DP (open or
    minimally invasive technique)
    – 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
    Patienten, die für eine primäre Pankreaslinksresektion geplant sind (offen oder minimal-invasiv)
    – Männer oder Frauen ≥18 Jahre alt
    – Fähigkeit des Patienten, Wesen und individuelle Konsequenzen der Studie zu verstehen
    – Unterschriebene Einwilligungserklärung
    – Bei gebärfähigen Frauen: Nachweis eines negativen Schwangerschaftstests in Urin oder Blut, und Bereitschaft zur adäquaten Kontrazeption bis einschließlich Tag 14 nach Studienintervention
    E.4Principal exclusion criteria
    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
    – Liver cirrhosis of any Child-Pugh grade
    – American Society of Anesthesiologists (ASA) score >III
    – Hypersensitivity to any botulinum toxin 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
    botulinum toxin 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 botulinum toxin application and either positive test
    or missing test for neutralizing antibodies to botulinum toxin
    – 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
    Schwere kardiovaskuläre Erkrankung (z.B. Herzinfarkt während der letzten 12 Monate, Herzinsuffizienz NYHA III/IV, instabile Angina pectoris)
    – Niereninsuffizienz, d.h. Kreatinin-Clearance nach Cockroft-Gault <30 mL/min
    – Leberzirrhose
    – American Society of Anesthesiologists (ASA)-Score >III
    – Überempfindlichkeit gegenüber Botulinumtoxin-Präparaten oder eines Bestandteils in der Formulierung
    – Neuromuskuläre Erkrankung, z.B. Periphere Motoneuron-Erkrankung, Amyotrophe Lateralsklerose oder Störung der neuromuskulären Synapse (z.B. Myasthenia gravis oder Lambert-Eaton-Syndrom) oder andere neurologische Erkrankung, einhergehend mit einem erhöhten Risiko einer Botox-Injektion
    – Zustand, aufgrund dessen eine Ösophagogastroduodenoskopie und/oder die Studienintervention nicht möglich oder zum gegenwärtigen Zeitpunkt obsolet ist, z.B. aus anatomischen Gründen oder bei Patienten mit akuter Pankreatitis
    – Vorausgehende Behandlung mit einem Botulinumtoxin-Präparat und entweder positiver Test oder nicht vorhandener Test auf neutralisierende Antikörper gegen Botulinumtoxin
    – Verständnis- oder Sprachprobleme
    – Incompliance
    – Schwangerschaft oder Stillzeit
    – Gleichzeitige Teilnahme an einer anderen Interventionsstudie
    – Jeglicher Zustand oder Situation, der/die nach Einschätzung des Prüfarztes mit einem erhöhten Risiko für den Patienten einhergeht und/oder die Studienergebnisse beeinflussen könnte
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the occurrence of clinically relevant POPF (grades B/C) according to the ISGPS and/or death within 30 days after distal pancreatectomy.
    Der primäre Endpunkt setzt sich zusammen aus der Häufigkeit klinisch relevanter postoperativer Pankreasfisteln (POPF Grade B und C nach ISGPS) und/oder Tod aufgrund jeglicher Ursache innerhalb von 30 Tagen nach Pankreaslinksresektion.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The combined primary endpoint is assessed during study visits on postoperative day (POD) 0, POD 3, day of clinical discharge and POD 30.
    Der kombinierte primäre Endpunkt wird durch Studienvisiten am Tag der Operation, am 3. postoperativen Tag, am Tag der Entlassung aus dem Krankenhaus und am 30. postoperativen Tag erfasst.
    E.5.2Secondary end point(s)
    The secondary endpoints are the following:
    - Overall POPF rate and severity of POPF (i.e. grades B and C, and also biochemical leakage) until POD 30 and within 3 months after the index operation defined according to the currently updated ISGPS definition
    - Postinterventional pancreatitis
    - Perioperative sepsis
    - Delayed gastric emptying (DGE)
    - Post-pancreatectomy hemorrhage (PPH)
    - Intraabdominal fluid collection/abscess
    - Lymphatic fistula/chylus ascites
    - Wound infection
    - Burst abdomen
    - Reinterventions/-operations due to any cause
    - Mortality
    - Quality of life
    - Intensive care unit (ICU)/intermediate care unit (IMC) stay
    - Total hospital stay
    - Readmission to hospital for management of postoperative complications
    For each endpoint, a definition is given in the clinical trial protocol.
    Die sekundären Endpunkte sind die folgenden:
    - Gesamtrate an postoperativen Pankreasfisteln (POPF) und deren Schweregrade (d.h. Grade B und C und auch „biochemical leakage“ nach aktualisierter Konsensusdefinition der ISGPS
    - Postinterventionelle Pankreatitis
    - Perioperative Sepsis
    - Verzögerte Magenentleerung
    - Postpankreatektomieblutung
    - Intraabdominelle Flüssigkeitskollektion/Abszess
    - Lymphfistel
    - Wundinfekt
    - Platzbauch
    - Reinterventionen/-Operationen
    - Gesamtmortalität
    - Lebensqualität
    - Dauer des Aufenthaltes auf der Intensivstation
    - Gesamtaufenthaltsdauer im Krankenhaus
    - Wiederaufnahme ins Krankenhaus aufgrund von postoperativen Komplikationen
    Jeder Endpunkt ist im Protokoll definiert.
    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 (distal pancreatectomy).
    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 (Pankreaslinksresektion) 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 Yes
    E.6.13.1Other scope of the trial description
    Feasibility
    Machbarkeit
    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
    No preoperative intervention
    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
    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 years1
    E.8.9.1In the Member State concerned months9
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 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 state60
    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 disease.
    Die Behandlung des Patienten nach Studienende entspricht der Standardbehandlung der zugrunde liegenden
    Bauchspeicheldrüsenerkrankung.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Institute of Medical Biometry and Informatics (IMBI)
    G.4.3.4Network Country Germany
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Coordination Center for Clinical Trials (KKS)
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-07
    P. End of Trial
    P.End of Trial StatusOngoing
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