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CompletedNCT03327142Updated Oct 31, 2017

EUS-guided FNA in the Study of the Adrenal Gland

An observational study in Adrenal Gland Disease and Adrenal Tumor, sponsored by Hospital Universitari de Bellvitge. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-31.

Sponsored by Hospital Universitari de Bellvitge · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
204
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Adrenal Gland Disease
  • Adrenal Tumor

Keywords

  • Adrenal Gland
  • Endoscopic Ultrasound Guided FNA
03

In context

Adrenal Gland Diseases

25 studies on the registry are indexed under Adrenal Gland Diseases; 7 are open to participants now.

This study's enrollment of 204 is below the median of 375 across 12 observational studies indexed under Adrenal Gland Diseases.

Browse Adrenal Gland Diseases studies →

Lead sponsor

Hospital Universitari de Bellvitge is the lead sponsor of 120 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Eligibility criteria

Inclusion Criteria:

  • All adrenal gland (Left / Right) punctured by endoscopic ultrasound
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
204 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testEndoscopic Ultrasound-Guided FNA

    Endoscopic Ultrasound Guided Fine Needle Aspiration of Puncture of Adrenal Glands

    Also known as: Endosonography

06

What researchers measure

Primary outcomes

  1. Diagnostic accuracy

    Time frame: retrospective analysis form 2003 to 2016

Secondary outcomes

  1. number of adverse events related to the procedure

    Time frame: retrospective analysis, last 10 years

  2. Predictors of malignancy

    Predictors of malignancy and cyto-pathological correlation of the EUS-FNA with adrenal gland

    Time frame: retrospective analysis, last 10 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2015 to primary completion in Jan 2016, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 29, 2017
First posted
Oct 31, 2017
StartActual
Dec 8, 2015
Primary completionActual
Jan 31, 2016
CompletionActual
Apr 30, 2016
Last update
Oct 31, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03327142
Responsible party
JOAN B GORNALS (Principal Investigator, Hospital Universitari de Bellvitge) — Principal investigator
First posted
Oct 31, 2017
Start date
Dec 8, 2015
Primary completion
Jan 31, 2016
Completion
Apr 30, 2016
Last update
Oct 31, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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