Status:
UNKNOWN
Is One Pass Enough for the Diagnosis of the Pancreatic Masses During EUS-FNB?
Lead Sponsor:
Istituto Clinico Humanitas Mater Domini
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
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. Major complications afte...
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.
- Able to 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.
Key Trial Info
Start Date :
June 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT05436704
Start Date
June 21 2022
End Date
June 30 2024
Last Update
June 29 2022
Active Locations (1)
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1
Humanitas-Mater Domini
Castellanza, Italy, 21053