Status:
UNKNOWN
Macroscopic on Site Evaluation (MOLSE) vs Standard Specimen Acquisition of Solid Lesions During EUS-FNB
Lead Sponsor:
Istituto Clinico Humanitas
Collaborating Sponsors:
Istituto Clinico Humanitas Mater Domini
Conditions:
Endoscopic Ultrasonography With Tissue Acquisition
Eligibility:
All Genders
18+ years
Phase:
NA
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 me...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2021
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT04486274
Start Date
July 17 2020
End Date
July 31 2021
Last Update
July 24 2020
Active Locations (1)
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1
Gastrointestinal Endoscopy Unit
Castellanza, Italy