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

RecruitingNAAges 18 Years - anyAllGCS Ramsay Santé pour l'Enseignement et la Recher…
NCT07657884 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * Patient with calcifying chronic pancreatitis * Presence of a communication with the main pancreatic duct on MRI or endoscopic ultrasound * Patient whose lesion meets criteria for malignancy (tissue mass, metastases, ascites, vascular infiltration) * Patient with a contraindication to endoscopic ultrasound-guided puncture (haemostatic disorder) * Patient with a known allergy to fluorescein (used in nCLE) * Pregnant woman * Patient under legal guardianship: adults under guardianship, curatorship or other legal protection, or deprived of their liberty by judicial or administrative order * Hospitalised patient without consent
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What it tests

  • SMI imaging
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Where

1 site
Hôpital Privé Jean Mermoz
Lyon, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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