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

NCT ID: NCT03485924

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-12
• Study Completion Date: 2023-07-26

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.

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. Participants will be assigned to the arms. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

EUS-FNA with ROSE

Intervention Type: DIAGNOSTIC_TEST

EUS-FNA with ROSE vs EUS-FNB without ROSE

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.

Group Type: ACTIVE_COMPARATOR

EUS-FNB without ROSE

Intervention Type: DIAGNOSTIC_TEST

EUS-FNA with ROSE vs EUS-FNB without ROSE

Interventions

EUS-FNA with ROSE

EUS-FNA with ROSE vs EUS-FNB without ROSE

Intervention Type: DIAGNOSTIC_TEST

EUS-FNB without ROSE

EUS-FNA with ROSE vs EUS-FNB without ROSE

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mouen Khashab

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00148609

Identifier Type: -

Identifier Source: org_study_id