EUS-guided FNA in the Study of the Adrenal Gland

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

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.

Study Overview

• Status: Completed
• Conditions: Adrenal Tumor; Adrenal Gland Disease
• Intervention / Treatment: Diagnostic test: Endoscopic Ultrasound-Guided FNA

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 Type: Observational
• Enrollment (Actual): 204

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Nationwide. Mailing-invitation to Spanish Society of Digestive Endoscopy (SEED) partners. Participation: 17 Spanish centers.

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnostic accuracy	retrospective analysis form 2003 to 2016

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2015
• Primary Completion (Actual): January 31, 2016
• Study Completion (Actual): April 30, 2016

Study Registration Dates

• First Submitted: March 29, 2017
• First Submitted That Met QC Criteria: October 30, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2017
• Last Update Submitted That Met QC Criteria: October 30, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Adrenal Gland; Endoscopic Ultrasound Guided FNA
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Adrenal Gland Neoplasms; Adrenal Gland Diseases
• Other Study ID Numbers: AdrenalG EUS-Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No