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

NCT02079285 | Completed DMC

• 1 other identifier: FNASROSE
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Sensitivity, specificity and accuracy of EUS-FNA without ROSE

  Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of EUS-FNA without ROSE

  7 days

Secondary Outcomes (1)

• Adequacy of obtained cytologic specimens

  7 days

Study Arms (1)

EUS-FNA

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

Procedure: EUS-FNA

Interventions

EUS-FNA PROCEDURE

EUS-FNA

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients who refuse to undergo EUS-FNA

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead

Study Sites (2)

Sungkyunkwan University Kangbuk Samsung Hospital

Seoul, 110-746, South Korea

Location

Sungkyunkwan University Kangbuk Samsung Hospital

Seoul, 110746, South Korea

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 2, 2014
• First Posted: March 5, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 24, 2016

Record last verified: 2016-02

Locations

KR (2)