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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • SMI (Superb Microvascular Imaging)

    Diagnostic test

    Imaging of endocystic material within PIMPT in SMI, using the new Aplio i800 EUS console (Canon-Olympus)

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: SMI groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Day 0

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: