Endoscopic Ultrasonography With Tissue Acquisition Clinical Trial
— MOSEOfficial title:
Macroscopic on Site Evaluation (MOLSE) vs Standard Specimen Acquisition of Solid Lesions During EUS-FNB: a Randomized Controlled Trial
| Verified date | July 2020 |
| Source | Istituto Clinico Humanitas |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 370 |
| Est. completion date | July 31, 2021 |
| Est. primary completion date | July 31, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Gastrointestinal Endoscopy Unit | Castellanza |
| Lead Sponsor | Collaborator |
|---|---|
| Istituto Clinico Humanitas | Humanitas Mater Domini |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To assess the diagnostic accuracy of EUS-FNB with MOSE vs EUS-FNB alone. | Diagnostic accuracy will be measure | 12 Months |