Trials Sponsors Conditions Drugs Pricing

Conditions

Fine Needle Aspiration Pancreatic Mass

Outcome Measures

Primary Outcomes (1)

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
Diagnostic accuracy will be defined as (true positive + true negative)/all participants in the arm.
6 months from the initial biopsy

Secondary Outcomes (4)

Specimen Adequacy
Post-procedure one week
Number of Histology Cores Obtained
Post-procedure one week
Median Number of Passes
6 months from the initial biopsy
Number of Technical Failures
After the procedure, an average of 1 hour

Study Arms (2)

EUS-FNA with ROSE

ACTIVE COMPARATOR

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-FNB without ROSE

ACTIVE COMPARATOR

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.

Interventions

EUS-FNA with ROSEDiagnostic test

EUS-FNA with ROSE vs EUS-FNB without ROSE

EUS-FNA with ROSE

EUS-FNB without ROSEDiagnostic test

EUS-FNA with ROSE vs EUS-FNB without ROSE

EUS-FNB without ROSE

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Sponsors & Collaborators

Johns Hopkins University
Otherlead

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21205, United States

MeSH Terms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Intervention Hierarchy (Ancestors)

Biopsy, Fine-NeedleBiopsy, NeedleBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisImage-Guided BiopsySpecimen HandlingUltrasonography, InterventionalUltrasonographyDiagnostic Imaging

Results Point of Contact

Title: Dr. Eun Ji Shin
Organization: Johns Hopkins Medical Institute

Study Officials

Mouen Khashab
Johns Hopkins University
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
Purpose: DIAGNOSTIC
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 3, 2018

Study Start

April 12, 2018

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

EUS-FNA with ROSE

EUS-FNB without ROSE

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Documents

Locations

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

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

EUS-FNA with ROSE

EUS-FNB without ROSE

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Documents

Locations