Clinical trial NCT04486274: Macroscopic on Site Evaluation (MOLSE) vs Standard Specimen Acquisition of Solid Lesions During EUS-FNB
Official title: Macroscopic on Site Evaluation (MOLSE) vs Standard Specimen Acquisition of Solid Lesions During EUS-FNB: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endoscopic Ultrasonography With Tissue Acquisition
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: Humanitas Mater Domini
First posted: 2020-07-24
Enrollment: 370
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To assess the diagnostic accuracy of EUS-FNB with MOSE vs EUS-FNB alone.
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Castellanza
country: Italy
facility: Gastrointestinal Endoscopy Unit
Study officials:
References:
citation: Mangiavillano B, Crino SF, Facciorusso A, Di Matteo F, Barbera C, Larghi A, Rizzatti G, Carrara S, Spadaccini M, Auriemma F, Fabbri C, Binda C, Coluccio C, Marocchi G, Staiano T, Conti Bellocchi MC, Bernardoni L, Eusebi LH, Cirota GG, De Nucci G, Stigliano S, Manes G, Bonanno G, Ofosu A, Lamonaca L, Paduano D, Spatola F, Repici A. Endoscopic ultrasound-guided fine-needle biopsy with or without macroscopic on-site evaluation: a randomized controlled noninferiority trial. Endoscopy. 2023 Feb;55(2):129-137. doi: 10.1055/a-1915-5263. Epub 2022 Aug 31.