EUS-guided FNA in the Study of the Adrenal Gland

Completed

• Conditions: Adrenal Gland Disease; Adrenal Tumor

• Registration Number: NCT03327142
• Lead Sponsor: Hospital Universitari de Bellvitge

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 Timeline

• Study Start: 2015-12-08
• Primary Completion: 2016-01-31
• Study Completion: 2016-04-30
• Study First Submitted: 2017-03-29
• Status Verified: 2017-08
• Study First Submitted QC: 2017-10-30
• Last Update Submitted: 2017-10-30
• Study First Posted: 2017-10-31
• Last Update Posted: 2017-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	retrospective analysis form 2003 to 2016

Secondary Outcome Measures

Name	Time	Method
number of adverse events related to the procedure	retrospective analysis, last 10 years
Predictors of malignancy	retrospective analysis, last 10 years	Predictors of malignancy and cyto-pathological correlation of the EUS-FNA with adrenal gland