- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07663734
Assessment of SMI (Superb Microvascular Imaging) for Characterising the Endocystic Material of Papillary Intraductal Mucinous Pancreatic Tumours (PIMPT) (ENDOKYSMILE)
There are many types of pancreatic cysts, and papillary intraductal mucinous pancreatic tumours (PIMPTs) are among the most common.
PIMPTs carry a risk of progressing to a cancerous lesion. To assess this risk, the key examination involves performing an endoscopic ultrasound combined with an injection of a contrast agent called Sonovue.
Superb Microvascular Imaging (SMI) is a new ultrasound modality that enables the analysis of PIMPTs without the need for a Sonovue injection.
The Mermoz Endoscopy Centre will be equipped with an ultrasound console enabling SMI to be performed during an endoscopic ultrasound examination.
This technology is now available on the new EUS Aplio i800 console (Canon-Olympus), which bears the CE mark.
To date, no data have been published on the potential of SMI for analysing a PIMPT. This is why this clinical investigation is being conducted
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Pancreatic cysts are becoming increasingly common in the general population. They are most often discovered incidentally during an imaging scan.
There are many types of pancreatic cystic lesions, but the most common are papillary intraductal mucinous pancreatic tumours (PIMPTs), serous cystadenomas (SCAs), mucinous cystic tumours (MCTs) (formerly known as mucinous cystadenomas), cystic neuroendocrine tumours, and solid and pseudopapillary tumours.
PIMPTs carry a risk of degeneration, which may arise from an initially benign wall-bound nodule (polyp) that can subsequently progress to a malignant lesion. The average rates of high-grade dysplasia/invasive carcinoma in surgical specimens of PIMPT from the secondary ducts and the main duct are 31% and 62% respectively. The presence of a wall-adherent nodule > 1 cm is a clear indication for pancreatic surgery to prevent neoplastic progression (or to treat it if it is already present within the nodule). However, PIMPTs also secrete mucus, which most often presents as a globule adhering to the wall, thus resembling a wall-adherent nodule.
The key examination for assessing a PIMPT is echoendoscopy, which enables the type of material present within the cyst to be characterised. The most sensitive standard Doppler technique (e-flow) is often unsuccessful (no visible vessels) or yields an inconclusive result, as the vessels present in the tissue nodules are very fine and have a very slow flow.
Currently, to distinguish mucus from a tissue nodule, an ultrasound contrast agent (Sonovue) is routinely used to detect microvascularisation. A tissue nodule takes up the contrast agent, whereas a mucus ball is avascular (no contrast uptake).
Superb Microvascular Imaging (SMI) is a new ultrasound mode that broadens the range of visible blood flow by revealing low-velocity microvascular flow. SMI is capable of visualising microvascular flow without the injection of contrast medium, unlike the current gold standard technique based on the injection of Sonovue.
The Mermoz Endoscopy Centre will be equipped with an ultrasound console enabling SMI to be performed during an echoendoscopy examination. This technology is now available on the new Aplio i800 EUS console (Canon-Olympus).
To date, no data have been published on the potential of SMI to characterise the endocystic material of PIMPTs. This is why this clinical investigation is being conducted.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Bertrand NAPOLEON, MD
- Numéro de téléphone: + 33 4 78 75 67 43
- E-mail: dr.napoleon@wanadoo.fr
Lieux d'étude
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Lyon, France, 69008
- Hôpital privé Jean Mermoz
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Contact:
- Bertrand NAPOLEON, MD
- Numéro de téléphone: + 33 4 78 75 67 43
- E-mail: dr.napoleon@wanadoo.fr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Patient referred for an endoscopic ultrasound assessment of a PIMPT
- Patient with endocystic material of undetermined nature measuring 3 mm or more
- Patient registered with or covered by the social security scheme
- Patient who speaks French
- Patient who has signed an informed consent form
Exclusion Criteria:
- Patient whose lesion meets the criteria for malignancy (tissue mass, metastases, ascites, vascular infiltration)
- Patient for whom Sonovue is contraindicated
- Pregnant woman
- Vulnerable patient: an adult under guardianship, curatorship or other legal protection, or deprived of their liberty by a judicial or administrative decision
- Patient admitted to hospital without consent
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: SMI group
Imaging of endocystic material within PIMPT in SMI, using the new Aplio i800 EUS console (Canon-Olympus)
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Imaging of endocystic material within PIMPT in SMI, using the new Aplio i800 EUS console (Canon-Olympus)
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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SMI sensitivity
Délai: Day 0
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Sensitivity is defined as the number of true positives (positive diagnoses in patients with a tissue nodule) divided by the total number of patients with a tissue nodule
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Day 0
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Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
Autres numéros d'identification d'étude
- 2026-A00625-46
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
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