Endoscopy Clinical Trials

Clinical trials related to Endoscopy Procedure

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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patient referred for confocal microscopy (nCLE) assessment of a pancreatic cyst of unknown origin

• Patient with a cyst measuring more than 15 mm in diameter and at least one cyst cavity measuring ≥ 5 mm (to allow nCLE to be performed)

• Patient registered with or covered by the National Health Service

• French-speaking patient who has signed an informed consent form

Locations
Other Locations
France
Hôpital Privé Jean Mermoz
RECRUITING
Lyon
Contact Information
Primary
Bertrand NAPOLEON, MD
dr.napoleon@wanadoo.fr
+ 33 4 78 75 67 43
Time Frame
Start Date: 2026-05-15
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 60
Treatments
Experimental: SMI group
Intervention involves acquiring B-mode images of the pancreatic cyst using SMI
Related Therapeutic Areas
Sponsors
Leads: GCS Ramsay Santé pour l'Enseignement et la Recherche

This content was sourced from clinicaltrials.gov