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

Endoscopic Ultrasound With Fine Needle Biopsy Versus Fine Needle Aspiration With On-Site Cytopathology in the Evaluation of Solid Pancreatic Masses: Randomized Single Blinded Clinical Trial

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.

Study Overview

• Status: Terminated
• Conditions: Fine Needle Aspiration; Pancreatic Mass
• Intervention / Treatment: Diagnostic test: EUS-FNA with ROSE; Diagnostic test: EUS-FNB without ROSE

Detailed Description

Endoscopic ultrasound (EUS) guided fine needle aspiration (EUS-FNA) is the primary technique for tissue acquisition for pancreatic lesions. Despite widespread adoption of the techniques, the diagnostic yield of EUS-FNA for pancreatic lesion is highly variable, with sensitivities ranging from 64-95%, specificities ranging from 75-100% and overall diagnostic accuracy ranging from 78-95%.

Despite its mainstay as the primary technique for tissue acquisition, EUS-FNA has several limitations. The standard EUS-FNA does not routinely provide core biopsy specimen with preserved tissue architecture, which is required for immunohistochemical staining and for definitive diagnosis of conditions, such as lymphoma, gastrointestinal stromal tumors, Immunoglobulin G (IgG)-4-associated lymphoplasmacytic sclerosing pancreatitis. Furthermore, the diagnostic yield of EUS-FNA is highly dependent on the availability of bedside cytotechnologist or cytopathologist for rapid onsite evaluation (ROSE), which increases the overall cost required to perform EUS-FNA.

Recently, multiple dedicated EUS fine needle biopsy (FNB) needles have been developed to obtain core specimens. Early small studies have shown promising results with these EUS-FNB needles.

The objective of this paired cohort study is to evaluate the diagnostic accuracy of EUS-FNA with ROSE compared to EUS-FNA with 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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eun Shin; Phone Number: 410-614-0950; Email: eshin3@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EUS-FNA with ROSE; 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-FNA with ROSE vs EUS-FNB without ROSE
Active Comparator: EUS-FNB without ROSE; 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; EUS-FNA with ROSE vs EUS-FNB without ROSE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The diagnostic accuracy of fine-needle biopsy (FNB) sampling without rapid onsite evaluation (ROSE) with the fine needle aspiration (FNA) with ROSE in pancreatic mass lesions	Diagnostic accuracy will be defined as (true positive + true negative)/all samples. The final diagnosis will be based on one of the following criteria: (i) surgical pathology specimen from patients who underwent surgical resection; (ii) cytological or histopathological diagnosis of malignancy in patients with unresectable disease with appropriate imaging and clinical course of disease; (iii) cytological and histopathological diagnosis of benign disease with an appropriate clinical course of disease for minimum of 6 months.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specimen adequacy	This will be defined as the proportion of samples in which a final histopathological diagnosis could be made.	2 years
Percentage of histology cores obtained	This will be defined as the proportion of samples in which a visible histology core biopsy was obtained	2 years
Number of passes	Number of passes required for diagnosis	2 years
Rate of technical failures	Technical failure was defined as the inability to perform the procedure, including the need to change the needle	2 years

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Mouen Khashab, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2018
• Primary Completion (Actual): July 26, 2023
• Study Completion (Actual): July 26, 2023

Study Registration Dates

• First Submitted: March 26, 2018
• First Submitted That Met QC Criteria: March 26, 2018
• First Posted (Actual): April 3, 2018

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB00148609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes