Clinical trial NCT03485924: EUS FNB Versus FNA With On-Site Cytopathology in Solid Pancreatic Masses
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fine Needle Aspiration
Pancreatic Mass
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: 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
timeFrame: 6 months from the initial biopsy
Secondary outcomes:
measure: Specimen Adequacy
timeFrame: Post-procedure one week
measure: Number of Histology Cores Obtained
timeFrame: Post-procedure one week
measure: Median Number of Passes
timeFrame: 6 months from the initial biopsy
measure: Number of Technical Failures
timeFrame: After the procedure, an average of 1 hour
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Mouen Khashab
role: PRINCIPAL_INVESTIGATOR
References: