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Clinical Trials/NCT03327142
NCT03327142CompletedNot Applicable

EUS-guided FNA in the Study of the Adrenal Gland: National Retrospective Multicenter Study

Hospital Universitari de Bellvitge0 sites204 target enrollmentStarted: December 8, 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
204
Primary Endpoint
Diagnostic accuracy

Study Overview

Brief Summary

To analyze the diagnostic performance, safety, impact on clinical management, predictors of malignancy and cyto-pathological correlation of the EUS-FNA with AG. National multicenter retrospective study. Mailing-SEED partners. Participation: 17 Spanish centers. Inclusion period: April / 2003 to April / 2016 Inclusion criteria: All AG (Left / Right) punctured by EUS.

A review of 205 EUS-FNA of AG in 200 patients is included.

Detailed Description

INTRODUCTION

The EUS has proven useful in the study and evaluation of the adrenal gland (AG) by endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), in both the left and right glands.

OBJECTIVE

To analyze the diagnostic performance, safety, impact on clinical management, predictors of malignancy and cyto-pathological correlation of the EUS-FNA with AG.

MATERIALS AND METHODS

National multicenter retrospective study. Mailing-SEED partners. Participation: 17 Spanish centers. Inclusion period: April / 2003 to April / 2016 Inclusion criteria: All AG (Left / Right) punctured by EUS. Variables reviewed: Demographic characteristics, clinical, extension studies, USE and pathological data. Comparison between variables; and estimation of multivariate logistic model for cytology, mortality and therapeutic change.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •All adrenal gland (Left / Right) punctured by endoscopic ultrasound

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Diagnostic accuracy

Time Frame: retrospective analysis form 2003 to 2016

Secondary Outcomes

  • number of adverse events related to the procedure(retrospective analysis, last 10 years)
  • Predictors of malignancy(retrospective analysis, last 10 years)

Investigators

Sponsor
Hospital Universitari de Bellvitge
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

JOAN B GORNALS

Principal Investigator

Hospital Universitari de Bellvitge

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