EUS-guided FNA in the Study of the Adrenal Gland | NCT03327142

Studies
EUS-guided FNA in the Study of the Adrenal Gland

NCT03327142

Sponsor

Hospital Universitari de Bellvitge

Status

Completed

Last Update Posted

Oct 31, 2017Actual

Enrollment

204Actual

Phase

Not provided

Conditions

Adrenal Gland Disease
Adrenal Tumor

Interventions

Endoscopic Ultrasound-Guided FNA

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 8, 2015Actual

Primary Completion Date

Jan 31, 2016Actual

Completion Date

Apr 30, 2016Actual

First Submitted Date

Mar 29, 2017

First Submission Date that Met QC Criteria

Oct 30, 2017

First Posted Date

Oct 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2017

Last Update Posted Date

Oct 31, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

JOAN B GORNALS, Principal Investigator, Hospital Universitari de BellvitgePrincipal Investigator

Lead Sponsor

Hospital Universitari de BellvitgeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

204Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic Ultrasound-Guided FNA	Diagnostic Test	Endoscopic Ultrasound Guided Fine Needle Aspiration of Puncture of Adrenal Glands		Endosonography

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000307	Adrenal Gland Diseases
D000310	Adrenal Gland Neoplasms

Ancestor Terms

ID	Term
D004700	Endocrine System Diseases
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D061765	Endoscopic Ultrasound-Guided Fine Needle Aspiration
D019160	Endosonography

Ancestor Terms

ID	Term
D044963	Biopsy, Fine-Needle
D001707	Biopsy, Needle
D001706	Biopsy
D003581	Cytodiagnosis

Browse Leaves

Not provided

Browse Branches

Not provided