Novel Crown-cut Biopsy Needle (FNB) vs Standard Aspiration Needle (FNA) for EUS-guided Diagnosis of SPLs

Peter Vilmann MD, DSc, HC, FASGE

Status: Unknown

Conditions: Pancreas Cancer; Pancreas Neoplasm

Treatments: Device: ProControl, MediGlobe; Device: TopGain, Medi-Globe

Study type: Interventional

Funder types: Other

Identifiers

NCT04687410

H-20006798

Details and patient eligibility

About

The aim of this study is to compare tissue quality and molecular yield between a novel crown-cut biopsy needle (FNB) and a standard aspiration needle (FNA) for EUS-guided diagnosis of solid pancreatic lesions.

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with a newly discovered SPL scheduled for EUS-guided tissue acquisition who can understand and provide a written consent.

Exclusion criteria

• Patients with uncorrected coagulopathies (INR >1.5 or platelet count <50,000) or patients treated with anticoagulants that cannot be discontinued.
• Pregnant or lactating females.
• Interposed, large vessels between the transducer and the target lesion.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups

FNA

Active Comparator group

Treatment:

Device: ProControl, MediGlobe

FNB

Experimental group

Treatment:

Device: TopGain, Medi-Globe