Endoscopic Ultrasound-guided Fine Needle Aspiration of Solid Masses: Histological and Immunohistochemical Evaluation

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT01437410

First received: September 9, 2011

Last updated: September 19, 2011

Last verified: September 2011

History of Changes

Purpose

The aim of this retrospective single center study was to evaluate the clinical utility of histological and immunohistochemical analyses of specimens obtained by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA).

Condition	Intervention	Phase
Pancreatic Mass Peripancreatic Mass	Procedure: EUS-FNA	Phase 4

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Retrospective
Official Title:	Endoscopic Ultrasound-guided Fine Needle Aspiration of Solid Masses: Histological and Immunohistochemical Evaluation

Resource links provided by NLM:

Genetics Home Reference related topics: Marfan syndrome

MedlinePlus related topics: Endoscopy

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

the diagnostic accuracy of cytology, histology, and combined analysis of specimens obtained by EUS-FNA for pancreatic or peripancreatic solid masses [ Time Frame: at least 6 months after surgery or clinical follow up ] [ Designated as safety issue: No ]
The first, pre-op checked each diagnostic accuracy of cytology, histology, and combined analysis by EUS-FNA. and then, finaly diagnosis following surgery or clinical follow up for at least 6 months was re-check with diagnosic accuracy of cytology, histology, and combined analysis pre-diagnosed by EUS-FNA

Biospecimen Retention: Samples Without DNA

cytopathologic result acquired by endoscopic ultrasound-guided fine needle aspiration (EUS-FNA).

Enrollment:	116
Study Start Date:	January 2009
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
EUS-FNA	Procedure: EUS-FNA tissue samples were harvested from 116 patients undergoing EUS-FNA of solid masses for cytologic smear and histological analysis.

Eligibility

Ages Eligible for Study:	30 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

patients who underwent EUS-FNA to evaluate solid pancreatic or peripancreatic lesions from January 2009 to July 2010 in Samsung Medical Center,

Criteria

Inclusion Criteria:

We retrospectively reviewed medical records of patients who underwent EUS-FNA to evaluate solid pancreatic or peripancreatic lesions from January 2009 to July 2010

Exclusion Criteria:

Patients with unavailable data

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437410

Locations

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710

Sponsors and Collaborators

Samsung Medical Center

More Information

No publications provided

Responsible Party:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT01437410 History of Changes
Other Study ID Numbers:	2011-01-044
Study First Received:	September 9, 2011
Last Updated:	September 19, 2011
Health Authority:	South Korea: Institutional Review Board

Additional relevant MeSH terms:

Marfan Syndrome
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities

Cardiovascular Diseases
Heart Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 21, 2013

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