Assessment of SMI (Superb Microvascular Imaging) for Characterising the Endocystic Material of Papillary Intraductal Mucinous Pancreatic Tumours (PIMPT)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

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

Qualifiers

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

Treatments tested in this trial

  • SMI (Superb Microvascular Imaging)

Treatment groups

60 Participants
are divided into 1 treatment group