NCT01437410

Brief Summary

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 20, 2011

Completed
Last Updated

September 20, 2011

Status Verified

September 1, 2011

Enrollment Period

1.5 years

First QC Date

September 9, 2011

Last Update Submit

September 19, 2011

Conditions

Pancreatic MassPeripancreatic Mass

Outcome Measures

Primary Outcomes (1)

  • the diagnostic accuracy of cytology, histology, and combined analysis of specimens obtained by EUS-FNA for pancreatic or peripancreatic solid masses

    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

    at least 6 months after surgery or clinical follow up

Study Arms (1)

EUS-FNA

Procedure: EUS-FNA

Interventions

EUS-FNAPROCEDURE

tissue samples were harvested from 116 patients undergoing EUS-FNA of solid masses for cytologic smear and histological analysis.

EUS-FNA

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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,

You may qualify if:

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

You may not qualify if:

  • Patients with unavailable data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

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 ImagingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2011

First Posted

September 20, 2011

Study Start

January 1, 2009

Primary Completion

July 1, 2010

Last Updated

September 20, 2011

Record last verified: 2011-09

Locations

KR(1)