Prospective Evaluation of Diagnostic Accuracy of Endoscopic Ultrasound-guided Fine Needle Aspiration and Biopsy (EUS-FNAB) in the Absence of Rapid Onsite Evaluation

Completed

• Conditions: Pancreatic Cancer
• Interventions: Procedure: EUS-FNA

• Registration Number: NCT02079285
• Lead Sponsor: Kangbuk Samsung Hospital

Brief Summary

\<Background/aims\> Rapid onsite evaluation (ROSE) of endoscopic ultrasound-guided fine needle aspiration and biopsy (EUS-FNAB) specimens by attending cytopathologists has been demonstrated to improve diagnostic yields of EUS-FNAB. The practice of ROSE, however, varies across EUS programs in Unites States, Europe and other areas of world. The investigators have a plan to perform prospective evaluation of the yield of EUS-FNAB in the absence of ROSE, in which the adequacy of specimens will be assessed by a single endosonographer.

\<Methods\> All EUS-FNAB procedures will be performed by an experienced endosonographer and the adequacy of specimens obtained during EUS-FNAB will be also assessed by a same endosonographer. A specimen will be considered adequate if there is an adequate number of representative cells from the lesion. Samples considered to be adequate will be then interpreted as malignancy, highly atypical suggestive of malignancy, atypical favor reactive change, or negative for malignancy. Performance characteristics of EUS-FNAB including sensitivity, specificity, and accuracy will be determined by comparing EUS-FNAB results with the final diagnoses of the lesions, based upon the surgical pathology or clinical follow-up of more than 6 months with repeat imagings.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-02
• Study First Submitted QC: 2014-03-04
• Study First Posted: 2014-03-05
• Study Start: 2014-04
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Any patients who will undergo EUS-FNA for the diagnostic evaluation of pancreas lesion

Exclusion Criteria

• Patients who refuse to undergo EUS-FNA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EUS-FNA	EUS-FNA	Any patients who will undergo EUS-FNA for pancreas lesion during the study period

Primary Outcome Measures

Name	Time	Method
Sensitivity, specificity and accuracy of EUS-FNA without ROSE	7 days	Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of EUS-FNA without ROSE

Secondary Outcome Measures

Name	Time	Method
Adequacy of obtained cytologic specimens	7 days

Trial Locations

Locations (1)

Sungkyunkwan University Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of