Comparison of FNB to EUS-CNB for Pancreatic Lesions

NCT07240818 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2321881
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diagnosis of a Pancreaticobiliary Disorder; Biopsy; EUS Guided Biopsy

Keywords

FNB; EUS-CNB; Endodrill; EUS guided biopsy

Outcome Measures

Primary Outcomes (1)

• Diagnostic specimen

  The percentage of cases achieving an adequate diagnostic yield (defined as a cellularity score of ≥2) after a single needle pass with either the EndoDrill or the 22-G FNB device

  during study intervention

Secondary Outcomes (3)

• Blood contamination of the specimen

  during study intervention

• cellularity score

  during study intervention

• Procedure Duration

  during study intervention

Study Arms (2)

EUS-FNB

ACTIVE COMPARATOR

This arm will undergo biopsy via the standard of care, which involves EUS-guided biopsy using the 22-gauge FNB needles

Procedure: EUS-FNB

EUS-CNB

EXPERIMENTAL

This arm will undergo biopsy with the novel EUS-CNB device

Device: endoscopic ultrasound guided biopsy with core needle biopsy device

Interventions

EUS-FNB PROCEDURE

Biopsy obtain via EUS-FNB

EUS-FNB

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-CNB

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who require EUS and tissue sampling of pancreatic solid lesions (size\> 2.5 cm)
• Patients who can give consent

You may not qualify if:

• patients without pancreatic lesions
• Pregnant females
• Hematologic and Coagulation disorders (platelets \< 50,000/mm3, INR \> 2, ANC \<1000)
• Patients with acute pancreatitis in the immediate 2 weeks before the procedure (if the lesion to be biopsied is in the pancreas)
• Cardiorespiratory dysfunction that precludes sedation
• patients unable to provide informed consent
• Previous chemotherapy or radiotherapy for a pancreatic neoplasm
• Patients who are not candidates for emergency surgery in case complications arise from the biopsy

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Publications (5)

• Mendoza Ladd A, Alsamman A, Meiklejohn K, Viramontes O. Initial experience with transmural use of a new endoscopic ultrasound electric core needle biopsy device: Case series. Endosc Int Open. 2024 Oct 28;12(10):E1237-E1241. doi: 10.1055/a-2427-2311. eCollection 2024 Oct.

  PMID: 39474489 RESULT

• Ding S, Lu A, Chen X, Xu B, Wu N, Edoo MIA, Zheng S, Li Q. Diagnostic accuracy of endoscopic ultrasound-guided fine-needle aspiration: A single-center analysis. Int J Med Sci. 2020 Oct 16;17(17):2861-2868. doi: 10.7150/ijms.48882. eCollection 2020.

  PMID: 33162814 RESULT

• Wong T, Pattarapuntakul T, Netinatsunton N, Ovartlarnporn B, Sottisuporn J, Chamroonkul N, Sripongpun P, Jandee S, Kaewdech A, Attasaranya S, Piratvisuth T. Diagnostic performance of endoscopic ultrasound-guided tissue acquisition by EUS-FNA versus EUS-FNB for solid pancreatic mass without ROSE: a retrospective study. World J Surg Oncol. 2022 Jun 24;20(1):215. doi: 10.1186/s12957-022-02682-3.

  PMID: 35751053 RESULT

• Swahn F, Glavas R, Hultin L, Wickbom M. The advent of the first electric driven EUS-guided 17 gauge core needle biopsy - A pilot study on subepithelial lesions. Scand J Gastroenterol. 2024 Jul;59(7):852-858. doi: 10.1080/00365521.2024.2336611. Epub 2024 Apr 15.

  PMID: 38618997 RESULT

• Gerke H, Rizk MK, Vanderheyden AD, Jensen CS. Randomized study comparing endoscopic ultrasound-guided Trucut biopsy and fine needle aspiration with high suction. Cytopathology. 2010 Feb;21(1):44-51. doi: 10.1111/j.1365-2303.2009.00656.x. Epub 2009 May 18.

  PMID: 19456845 RESULT

Central Study Contacts

Antonio H Mendoza Ladd, MD

CONTACT

5052199902; ahmendozaladd@health.ucdavis.edu

Michael Ladna, MD

CONTACT

6193896729; mladna@health.ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The study participant (patient) and pathologist reviewing the biopsy specimen will be masked. The endoscopist performing the procedure will not be masked
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: November 21, 2025
• Study Start: May 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (1)