About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
SMI (Superb Microvascular Imaging)
Diagnostic testImaging of endocystic material within PIMPT in SMI, using the new Aplio i800 EUS console (Canon-Olympus)
Treatment groups
Trial outcomes
Primary outcomes
SMI sensitivity
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
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: