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Procedure

EUS-FNB without ROSE for Fine Needle Aspiration

N/A
Waitlist Available
Led By Mouen Khashab
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing whether a less expensive and simpler pancreatic cancer diagnosis procedure is just as good as the current standard.

Eligible Conditions
  • Pancreatic Mass
  • Fine Needle Aspiration

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
Number of passes
Percentage of histology cores obtained
Rate of technical failures
+1 more

Trial Design

2Treatment groups
Active Control
Group I: EUS-FNB without ROSEActive Control1 Intervention
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 II: EUS-FNA with ROSEActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,259 Previous Clinical Trials
14,820,618 Total Patients Enrolled
Mouen KhashabPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any recruitment opportunities for this clinical experiment right now?

"Evidenced by the clinicaltrials.gov database, this trial is presently enrolling participants. First posted on April 12th 2018 and most recently updated December 10th 2021, applicants are welcome to apply now."

Answered by AI

What is the maximum capacity for participation in this experiment?

"Affirmative. Clinicaltrials.gov documents that this research study is actively enrolling patients, starting from April 12th 2018 and was last updated on December 10th 2021. The trial needs to recruit 132 individuals across a single site."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
EUS FNB Versus FNA With On-Site Cytopathology in Solid Pancreatic Masses
2018. "EUS FNB Versus FNA With On-Site Cytopathology in Solid Pancreatic Masses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03485924.
~5 spots leftby Apr 2025
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