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Clinical Trials/NCT04486274
NCT04486274UnknownNot Applicable

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

Istituto Clinico Humanitas1 site in 1 country370 target enrollmentStarted: July 17, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
370
Locations
1
Primary Endpoint
To assess the diagnostic accuracy of EUS-FNB with MOSE vs EUS-FNB alone.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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.

Outcomes

Primary Outcomes

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

Time Frame: 12 Months

Diagnostic accuracy will be measure

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Istituto Clinico Humanitas
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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