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

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ClinicalTrials.gov Identifier: NCT02079285
Recruitment Status : Completed
First Posted : March 5, 2014
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
Hong Joo Kim, 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.


Condition or disease Intervention/treatment
Pancreatic Cancer Procedure: EUS-FNA

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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of the Yield and Diagnostic Accuracy of Endoscopic Ultrasound-guided Fine Needle Aspiration and Biopsy in the Absence of Rapid Onsite Evaluation
Study Start Date : April 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
EUS-FNA
Any patients who will undergo EUS-FNA for pancreas lesion during the study period
Procedure: EUS-FNA



Primary Outcome Measures :
  1. Sensitivity, specificity and accuracy of EUS-FNA without ROSE [ Time Frame: 7 days ]
    Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of EUS-FNA without ROSE


Secondary Outcome Measures :
  1. Adequacy of obtained cytologic specimens [ Time Frame: 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patients who will undergo EUS-FNA for the diagnostic evaluation of pancreas lesion
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079285


Locations
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Korea, Republic of
Sungkyunkwan University Kangbuk Samsung Hospital
Seoul, Korea, Republic of, 110-746
Sungkyunkwan University Kangbuk Samsung Hospital
Seoul, Korea, Republic of, 110746
Sponsors and Collaborators
Kangbuk Samsung Hospital

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Responsible Party: Hong Joo Kim, MD, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier: NCT02079285     History of Changes
Other Study ID Numbers: FNASROSE
First Posted: March 5, 2014    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016