Endoscopic Ultrasonography With Tissue Acquisition
Conditions
Brief summary
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.
Interventions
OTHERMOSE
After each pass, the stylet will be introduced into the needle, the material will be released onto a smear slide, and a macroscopic on-site quality evaluation (MOSE) of the specimen will be performed by the endoscopist.
Sponsors
Istituto Clinico Humanitas Mater Domini
Istituto Clinico Humanitas
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the diagnostic accuracy of EUS-FNB with MOSE vs EUS-FNB alone. | 12 Months | Diagnostic accuracy will be measure |
Countries
Italy
Outcome results
None listed