Comparison of FNB to EUS-CNB for Pancreatic Lesions

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT07240818
Status
Not Yet Recruiting

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Conditions

  • Biopsy
  • Diagnosis of a Pancreaticobiliary Disorder
  • EUS Guided Biopsy

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • endoscopic ultrasound guided biopsy with core needle biopsy device — DEVICE
    The EUS-CBD (Endodrill, Bibb Medical, Lund Sweden) differs from currently available needles (FNB) in that it obtains tissue by drilling into target lesions rather than puncturing them.
  • EUS-FNB — PROCEDURE
    Biopsy obtain via EUS-FNB

Study Details

The primary aim of this study is to compare the tissue specimen quality and diagnostic accuracy of biopsies obtained with one puncture of a regular 22 FNB G needle and the motorized EUS CNB device of pancreatic lesions. The secondary aims are to compare the rate of blood contamination in the specimens obtained from biopsies of pancreatic lesions and the overall procedure duration. The hypothesis of this study is that the proportion of cases in which a single puncture of the lesion in question delivers adequate diagnostic tissue is higher with the motorized EUS CNB than with the 22 G FNB.

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: EUS-FNB
    This arm will undergo biopsy via the standard of care, which involves EUS-guided biopsy using the 22-gauge FNB needles
  • Experimental: EUS-CNB
    This arm will undergo biopsy with the novel EUS-CNB device

Primary Outcome Measure

Diagnostic specimen [ Time Frame: during study intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC Davis Medical CenterSacramentoCalifornia95817
Antonio Mendoza Ladd, MD
[email protected]
505-219-9902
Michael Ladna, MD
[email protected]
6193896729

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By research site
UC Davis Medical Center· Sacramento, CA

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