- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04840537
Cholangioscopy or Conventional Techniques for Indeterminate Biliary Stenosis
Comparison of Two Diagnostic Strategies in Indeterminate Biliary Stenosis: Exploration by Retrograde Cholangioscopy From the Outset or After Failure of Conventional Techniques
Biliary stenosis not associated with a mass is difficult to diagnose with certainty. The diagnosis is usually based on a first-line cytological study of biliary brushing, which allows a diagnosis in 30 to 50% of cases. In the event of negativity, it is then possible to perform a cholangioscopy in a second step, which allows better sensitivity by performing biopsies. Performing cholangioscopy from the start could potentially save time and avoid disturbances associated with intermediate biliary stenting.
The main objective is to compare two strategies for exploring indeterminate biliary stenosis (1st vs. 2nd line retrograde cholangioscopy) in terms of diagnostic performance. The secondary objectives are to compare the same two strategies in terms of effectiveness, side effects and cost-effectiveness.
The primary outcome measure is the diagnostic yield (performance) of the initial investigation of indeterminate biliary stenosis: cytological brushing followed by cholangioscopy in case of failure (control group) or cholangioscopy from the start (study group).
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Frederic Prat, MD, PhD
- Numéro de téléphone: +33 (0)140875663
- E-mail: frederic.prat@aphp.fr
Sauvegarde des contacts de l'étude
- Nom: Diane Lorenzo, MD
- E-mail: diane.lorenzo@aphp.fr
Lieux d'étude
-
-
-
Clichy, France, 92110
- Recrutement
- Hopital Beaujon
-
Contact:
- frederic prat, MD, PhD
- Numéro de téléphone: +33 (0)140875663
- E-mail: maximilien.barret@aphp.fr
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Presence of intra- or extrahepatic biliary stenosis, involving the main bile ducts: common hepatic duct, right and left hepatic ducts
- Presence of clinical jaundice and / or biological cholestasis (GGT> 3N)
- Absence of visible mass near the biliary stenosis after initial morphological assessment by abdominal CT scan, MRI with biliary sequences.
- Endoscopic ultrasound performed and not having allowed the acquisition of material of diagnostic interest by guided puncture of the lesion.
- No history of ERCP in the 6 months preceding inclusion and no biliary prosthesis (plastic or metal) in place at the time of inclusion
- Collegial validation of the need for a formal diagnosis of indeterminate biliary stenosis in order to guide therapeutic management
- Patients aged 18 to 85
- Patient who gave his consent to participate in the study
- No contraindication to anesthesia (ASA 1, 2,3)
- Patient affiliated to a social security scheme (beneficiary or beneficiary)
- Absence of pregnancy and current contraception in women of childbearing age
Exclusion Criteria:
- Presence of a manifest tissue mass in relation to the biliary stenosis on CT and / or MRI imaging.
- Very strong presumption of the etiological diagnosis of biliary stenosis given the history (history, background): i.e. liver surgery, cholecystectomy, autoimmunity
- History of ERCP and / or percutaneous biliary drainage in the 6 months preceding inclusion
- Presence of a plastic or metal biliary prosthesis in place at the time of inclusion
- History of cephalic duodeno-pancreatectomy or hepatico-jejunal anastomosis
- Non-passable stenosis of the main bile duct
- Severe coagulopathy, thrombocytopenia <75,000 G / L, treatment with clopidogrel cannot be interrupted even temporarily
- Anesthetic contraindication (ASA 4)
- Inability to obtain informed consent
- person deprived of liberty
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: cytological brushing followed by cholangioscopy in case of failure
|
endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure for exploration of an indeterminate biliary stenosis and biliary drainage
|
|
Expérimental: cholangioscopy from the start
|
endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure for exploration of an indeterminate biliary stenosis and biliary drainage
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Diagnostic yield (performance) of the initial investigation of indeterminate biliary stenosis: cytological brushing followed by cholangioscopy in case of failure (control group) or cholangioscopy from the start (study group).
Délai: 48 months
|
Diagnostic performance is expressed primarily by sensitivity for the diagnosis of malignancy.
|
48 months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Specific rate of diagnosis with cholangioscopy by spyglass used in 1st or 2nd intention
Délai: 48 months
|
48 months
|
|
Rate of adverse events related to diagnostic procedures in each of the 2 groups
Délai: 48 months
|
48 months
|
|
Comparison of the costs of the 2 diagnostic strategies
Délai: 48 months
|
48 months
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SFED 131
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .