NCT04895111

Brief Summary

Strain elastography (SE) is an imaging method used for the measurement of relative tissue elasticity through qualitative (color pattern) or semi-quantitative methods (strain ratio or strain histogram). Very recently, the first pilot study has provided preliminary evidence that EBUS-SE elastography may help identify fibrotic lymph nodes in sarcoidosis and that sampling lymph nodes characterized by low strain elastography, that is "stiff" nodes, is associated with an increased risk of retrieving an inadequate sample (i.e. a sample which is not representative of the lymph node tissue). The investigators hypothesize that an EBUS-SE pattern indicative of lymph node stiffness will be associated with less granulomas and more fibrosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
701

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 10, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

October 27, 2023

Status Verified

August 1, 2023

Enrollment Period

2.4 years

First QC Date

May 17, 2021

Last Update Submit

October 26, 2023

Conditions

Sarcoidosis, Pulmonary

Keywords

SarcoidosisEndobronchial UltrasoundElastographyEndosonographyGranuloma

Outcome Measures

Primary Outcomes (1)

  • • Diagnostic yield for the detection of granulomas on endosonography samples according to a mean value of the strain histogram <40 or ≥40

    The diagnostic yield for the detection of granulomas will be measured on a per lymph node basis (number of lymph nodes in which the pathological exam of endosonography samples identifies granulomas/number of lymph nodes submitted to endosonography)

    15 days

Secondary Outcomes (2)

  • • Adequacy of endosonography samples according to a mean value of the strain histogram <40 or ≥40.

    15 days

  • • Correlation between the strain elastography pattern measured with the mean value of the strain histogram and the following variables: age, sex, sarcoidosis stage (I vs II vs III), duration of sarcoidosis-related symptoms.

    1 month

Study Arms (1)

Patients with suspected sarcoidosis

Consecutive patients with clinical and radiological (CT scan +/- PET) suspect of sarcoidosis

Diagnostic Test: Endobronchial ultrasound strain elastography

Interventions

Endobronchial ultrasound strain elastographyDIAGNOSTIC_TEST

Measurement of tissue elasticity of hilar and mediastinal lymph nodes through strain elastography measured during an endonbronchial ultrasound examination

Patients with suspected sarcoidosis

Eligibility Criteria

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

Patients with a clinical and radiological suspect of sarcoidosis.

You may qualify if:

  • Age 18 years or older.
  • ASA physical status I-III.
  • Clinical/radiological (computed tomography) suspicion of sarcoidosis (Stages I to III)

You may not qualify if:

  • Inability or unwillingness to consent.
  • Severe bleeding disorders
  • Contraindication for temporary interruption of the use of anticoagulant or antiplatelet therapy different from aspirin.
  • Recent and/or uncontrolled cardiac disease, uncontrolled pulmonary hypertension.
  • Compromised upper airway (eg, concomitant head and neck cancer or central airway stenosis for any reason).
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Sarcoidosis, PulmonarySarcoidosisGranuloma

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Rocco Trisolini, MD

CONTACT

+390630154204rocco.trisolini@policlinicogemelli.it

Fausto Leoncini, MD

CONTACT

fausto.leoncini@policlinicogemelli.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2021

First Posted

May 20, 2021

Study Start

May 10, 2021

Primary Completion

September 30, 2023

Study Completion

March 31, 2024

Last Updated

October 27, 2023

Record last verified: 2023-08

Locations

IT(1)