EUS-guided FNA in the Study of the Adrenal Gland

Adrenal Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03327142
• Other study ID #: AdrenalG EUS-Study
• Status: Completed
• Phase: N/A
• First received: March 29, 2017
• Last updated: October 30, 2017
• Start date: December 8, 2015
• Est. completion date: April 30, 2016

Study information

• Verified date: August 2017
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: April 30, 2016
• Est. primary completion date: January 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Adrenal Gland Disease
• Adrenal Gland Diseases
• Adrenal Gland Neoplasms
• Adrenal Tumor

Intervention

Diagnostic Test:
• Endoscopic Ultrasound-Guided FNA
Endoscopic Ultrasound Guided Fine Needle Aspiration of Puncture of Adrenal Glands

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy		retrospective analysis form 2003 to 2016
Secondary	number of adverse events related to the procedure		retrospective analysis, last 10 years
Secondary	Predictors of malignancy	Predictors of malignancy and cyto-pathological correlation of the EUS-FNA with adrenal gland	retrospective analysis, last 10 years