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

Pancreatic Mass Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03485924
• Other study ID #: IRB00148609
• Status: Terminated
• Phase: N/A
• Start date: April 12, 2018
• Est. completion date: July 26, 2023

Study information

• Verified date: July 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: July 26, 2023
• Est. primary completion date: July 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fine Needle Aspiration
• Pancreatic Mass

Intervention

Diagnostic Test:
• EUS-FNA with ROSE
EUS-FNA with ROSE vs EUS-FNB without ROSE
• EUS-FNB without ROSE
EUS-FNA with ROSE vs EUS-FNB without ROSE

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Specimen adequacy	This will be defined as the proportion of samples in which a final histopathological diagnosis could be made.	2 years
Secondary	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
Secondary	Number of passes	Number of passes required for diagnosis	2 years
Secondary	Rate of technical failures	Technical failure was defined as the inability to perform the procedure, including the need to change the needle	2 years