NCT03327142

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 8, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
Last Updated

October 31, 2017

Status Verified

August 1, 2017

Enrollment Period

2 months

First QC Date

March 29, 2017

Last Update Submit

October 30, 2017

Conditions

Adrenal Gland DiseaseAdrenal Tumor

Keywords

Adrenal GlandEndoscopic Ultrasound Guided FNA

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy

    retrospective analysis form 2003 to 2016

Secondary Outcomes (2)

  • number of adverse events related to the procedure

    retrospective analysis, last 10 years

  • Predictors of malignancy

    retrospective analysis, last 10 years

Interventions

Endoscopic Ultrasound-Guided FNADIAGNOSTIC_TEST

Endoscopic Ultrasound Guided Fine Needle Aspiration of Puncture of Adrenal Glands

Also known as: Endosonography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Adrenal Gland DiseasesAdrenal Gland Neoplasms

Interventions

Endoscopic Ultrasound-Guided Fine Needle AspirationEndosonography

Condition Hierarchy (Ancestors)

Endocrine System DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Biopsy, Fine-NeedleBiopsy, NeedleBiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisImage-Guided BiopsySpecimen HandlingUltrasonography, InterventionalUltrasonographyDiagnostic ImagingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2017

First Posted

October 31, 2017

Study Start

December 8, 2015

Primary Completion

January 31, 2016

Study Completion

April 30, 2016

Last Updated

October 31, 2017

Record last verified: 2017-08