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RECRUITING
NCT07657884
NA

Assessment of the Usefulness of SMI (Superb Vascular Imaging) for the Characterisation of Pancreatic Cystic Tumours (IMAKYST)

Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

View on ClinicalTrials.gov

Summary

A cystic lesion is an abnormal cavity formed within tissue or an organ, which may contain a liquid, semi-solid or gaseous substance. There are different types of pancreatic cystic lesions: lesions that may become cancerous and completely benign lesions that do not require monitoring, such as serous cystadenomas (SCs) and pseudocysts. Diagnostic difficulties mean that one in three patients with a SC undergoes unnecessary surgery with significant morbidity and mortality (risk of death). Currently, needle-based confocal laser endomicroscopy (nCLE) is the gold standard technique for the diagnosis of SC. SC is a lesion characterised by an extensive network of small blood vessels present in all the cyst walls and throughout the cyst's peripheral capsule. SMI (Superb Vascular Imaging) is a new ultrasound mode that improves the visibility of blood flow in the vessels without the injection of contrast medium (a diagnostic agent used for certain medical imaging examinations, most often administered intravenously), unlike nCLE. 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 EUS Aplio i800 console (Canon-Olympus), which is CE marked. To date, no data has been published on the potential of SMI to characterise and diagnose CS. This is why this clinical investigation is being conducted.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-05-15

Completion Date

2027-11-30

Last Updated

2026-06-18

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

SMI imaging

B-mode imaging of pancreatic cysts with SMI using the new Aplio i800 EUS console (Canon-Olympus)

Locations (1)

Hôpital Privé Jean Mermoz

Lyon, France