- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01769248
Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle (MUCIN)
Randomized Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle
Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved.
The Echotip Procore (Cook Medical) core biopsy needle (ETP), has been demonstrated to provide excellent efficacy for core biopsy samples. Final diagnostic yield using this needle ranges from 80-90% and appears to be significantly greater than EUS-FNA for lesions requiring histology for diagnosis. However, there is currently only limited data from prospective studies comparing EUS-FNA to EUS-FNB with the ETP needle. The investigators propose a randomized, prospective, cross-over study comparing diagnostic accuracy of EUS-FNA to EUS-FNB.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved.
We will compare tissue samples obtained by standard FNA to FNB with a sample size of 140 patients with the primary outcome being diagnostic yield. Each patient will be randomized to FNA or FNA. If after 3 passes the on-site evaluation remains inadequate, the endoscopist will crossover to the other arm.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
California
-
Los Angeles, California, États-Unis, 90095
- UCLA Medical Center
-
San Francisco, California, États-Unis, 94117
- California Pacific Medical Center
-
-
Florida
-
Tampa, Florida, États-Unis, 33612
- Moffit Cancer Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 3.1.1 All patients referred for EUS tissue sampling who provide informed consent
Exclusion Criteria:
- 3.2.1 Coagulopathy which is not corrected
3.2.2 Diagnostic EUS determines lesion is not amenable to FNA or FNB
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur actif: Fine needle aspiration
fine needle aspiration
|
Fine needle aspiration
Autres noms:
FNB
Autres noms:
|
Comparateur actif: Fine needle biopsy
|
Fine needle aspiration
Autres noms:
FNB
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Diagnostic Yield of EUS-FNB and EUS-FNA
Délai: 1 year
|
The investigators' primary outcome measure will assess the diagnostic yield (percentage of patients with a diagnosis) of EUS-FNB (fine-needle biopsy) to provide a final diagnosis of the lesion being sampled.
This will be expressed as a percentage.
|
1 year
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB
Délai: 1 year
|
The investigators' secondary outcome will assess the ability to obtain an adequate specimen for in room cytologic evaluation as determined by our cytopathologist.
This will be defined as a sample that is representative (not necessarily diagnostic) of the lesion in question.
This will be expressed as a percentage and compared between FNA and FNB
|
1 year
|
Percentage of Patients in Whom a Diagnosis is Achieved After Crossover (%)
Délai: 1 yr
|
As above.
Crossover to FNA or FNB occurs after 3 passes without adequate material
|
1 yr
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Srinadh Komanduri, Northwestern University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
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
- FNAFNBmucin
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 .
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