跳至主要内容
临床试验/NCT04486274
NCT04486274Unknown不适用

Macroscopic on Site Evaluation (MOLSE) vs Standard Specimen Acquisition of Solid Lesions During EUS-FNB: a Randomized Controlled Trial

Istituto Clinico Humanitas1 个研究点 分布在 1 个国家目标入组 370 人开始时间: 2020年7月17日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
370
试验地点
1
主要终点
To assess the diagnostic accuracy of EUS-FNB with MOSE vs EUS-FNB alone.

研究概览

简要总结

Endoscopic ultrasonography (EUS) with tissue acquisition (TA) is nowadays a well-established technique for the sampling of solid lesions pancreatic and non-pancreatic lesions. Actually the standard methods to obtain sampling in gastrointestinal (GI) and non-GI solid masses is the fine needle aspiration (FNA) performed by endoscopic ultrasonography (EUS). Its sensitivity, specificity and diagnostic accuracy for malignant cytology are actually reported of 85-95%, 95%-98% and 78-95% respectively. These data could be affected by the presence of cytopathologist in endoscopy room during the tissue sampling. The rapid on-site evaluation (ROSE) has been advocated to significantly increase EUS-FNA accuracy. To overcome this problem fine needle biopsy (FNB) for TA to obtain histological specimens was proposed. These needles allow as the acquisition of an histological specimen than the cytological one with FNA needles. Recently, the need to obtain a histological, instead of a cytological, specimen during EUS has become more urgent and necessary due to innovative oncological treatment options. An acquired histological specimen could avoid the need of a cytopathologist in the endoscopic room, diminishing costs, procedures time, number of passes and reducing the additional costs of a possible repeated EUS-FNA, in case of an inconclusive diagnosis.

With the advent of FNB, the macroscopic on-site evaluation (MOSE) of the specimen by the endosonographer was proposed, resulting in a comparable alternative to ROSE.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Other
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

入选标准

  • Age greater than 18, both genders.
  • Both in-patient and out-patients.
  • Presence of a solid lesion. In the presence of a cystic component, the solid part of the lesion should be more 75% of the total.
  • FNB performed by a 22G needle Acquire® (Boston Scientific).
  • Tissue acquisition with fanning technique.
  • Obtained informed consent.

排除标准

  • Patients underwent EUS-FNA with or without ROSE
  • Patients underwent EUS-FNB plus ROSE.
  • Previous biopsy of the lesion with diagnosis of malignancy
  • Presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma.
  • Pregnancy or breast-feeding.
  • Patients unable to understand and/or read the consent form.
  • Inclusion in other study.

结局指标

主要结局

To assess the diagnostic accuracy of EUS-FNB with MOSE vs EUS-FNB alone.

时间窗: 12 Months

Diagnostic accuracy will be measure

次要结局

未报告次要终点

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

研究点 (1)

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