EUS FNB Versus FNA With On-Site Cytopathology in Solid Pancreatic Masses

NCT03485924 | Terminated Results DMC FDA Device

• 1 other identifier: IRB00148609
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this paired cohort study is to evaluate the diagnostic accuracy of Endoscopic Ultrasound-fine needle aspiration (EUS-FNA) with rapid onsite evaluation (ROSE) compared to EUS-fine needle biopsy (EUS-FNB) without ROSE. If EUS-FNB without ROSE is shown to be non-inferior to the current standard of care of EUS-FNA with ROSE in pancreatic lesions, this study has the potential to make EUS-guided tissue acquisition more economical (with elimination for the need for cytopathology staff onsite) as well as provide core histological specimen without sacrificing the overall diagnostic yield.

Conditions

Fine Needle Aspiration; Pancreatic Mass

Outcome Measures

Primary Outcomes (1)

• The Diagnostic Accuracy of Fine-needle Biopsy (FNB) Sampling Without Rapid Onsite Evaluation (ROSE) and the Fine Needle Aspiration (FNA) With ROSE in Pancreatic Mass Lesions

  Diagnostic accuracy will be defined as (true positive + true negative)/all participants in the arm.

  6 months from the initial biopsy

Secondary Outcomes (4)

• Specimen Adequacy

  Post-procedure one week

• Number of Histology Cores Obtained

  Post-procedure one week

• Median Number of Passes

  6 months from the initial biopsy

• Number of Technical Failures

  After the procedure, an average of 1 hour

Study Arms (2)

EUS-FNA with ROSE

ACTIVE COMPARATOR

EUS/FNA with ROSE will be performed using standard techniques via 22-g FNA needle (Cook Medical EchoTip Ultra or Boston Scientific Expect or Medtronic Beacon). Lesions will be identified using EUS and punctured with the FNA needle (10-15 back and forth movements per needle pass, fanning as appropriate). After the lesion is punctured, the stylet will be removed and 10cc suction will be applied. FNA specimens will be processed for ROSE using standard techniques with bedside smear slide evaluation and liquid-based cytology and cell-block preparation.

Diagnostic Test: EUS-FNA with ROSE

EUS-FNB without ROSE

ACTIVE COMPARATOR

EUS/FNB without ROSE will be performed using similar techniques for tissue acquisition as FNA using 22-g FNB needle (Medtronic SharkCore or Boston Scientific Acquire). Lesions will be identified using EUS and punctured with the 22-g FNB needle (10-15 back and forth movements per needle pass, fanning as appropriate). After the lesion is punctured, the stylet will be removed and 10cc suction will be applied. FNB samples will be placed directly into formalin containers and sent to be processed by surgical pathology.

Diagnostic Test: EUS-FNB without ROSE

Interventions

EUS-FNA with ROSE DIAGNOSTIC_TEST

EUS-FNA with ROSE vs EUS-FNB without ROSE

EUS-FNA with ROSE

EUS-FNB without ROSE DIAGNOSTIC_TEST

EUS-FNA with ROSE vs EUS-FNB without ROSE

EUS-FNB without ROSE

Eligibility Criteria

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

You may qualify if:

• Patient ≥ 18 years of age referred for EUS-guided biopsy for pancreatic mass lesions

You may not qualify if:

• Refusal to consent form
• Uncorrectable coagulopathy (INR \> 1.5)
• Uncorrectable thrombocytopenia (platelet \< 50,000)
• Uncooperative patients
• Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
• Medically unstable for sedation
• Entirely cystic lesions
• Lesions inaccessible to EUS

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Results Point of Contact

• Title: Dr. Eun Ji Shin
• Organization: Johns Hopkins Medical Institute

eshin3@jhmi.edu

4106140950

Study Officials

• Mouen Khashab

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 3, 2018
• Study Start: April 12, 2018
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)