Assessment of the Usefulness of SMI (Superb Vascular Imaging) for the Characterisation of Pancreatic Cystic Tumours (IMAKYST)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
Pancreatic cysts are becoming increasingly common in the general population. They are most often discovered incidentally during cross-sectional abdominal imaging.
There are different types of pancreatic cystic lesions, each with distinct risks of progression. Lesions with the potential for malignant transformation are typically mucinous lesions (papillary intraductal mucinous neoplasms of the pancreas [PIMN] and mucinous cystic neoplasms [MCN]), formerly known as mucinous cystadenomas), whereas non-mucinous lesions (serous cystadenomas [SCs] and pseudocysts) are entirely benign and do not require monitoring.
SC typically presents as a solitary cyst with no communication with the Wirsung duct, appearing microcystic with central calcification. This typical appearance is not always present, and SC can mimic a mucinous lesion. In such cases, imaging and echoendoscopy findings are not discriminatory. Histological and biochemical analysis of the fluid obtained during cyst aspiration may be helpful, but the specificity is usually insufficient to make a definitive decision regarding the absence of surgery and the need for monitoring. These diagnostic difficulties mean that one in three patients with SC undergo unnecessary surgery, with significant morbidity and mortality.
There are currently two highly effective techniques for diagnosing SC:
- Endocystic microbiopsy, which has a diagnostic accuracy of nearly 100% but a high complication rate (around 10%). It is no longer recommended except in exceptional cases.
- Needle-based confocal laser endomicroscopy (nCLE), which has 100% specificity for the diagnosis of SC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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