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E- Predict: EBUS ELASTOGRAPHY STRAIN in Lung Cancer

NCT ID: NCT02488928

Last Updated: 2019-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

327 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2019-04-30

Brief Summary

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EBUS elastography is a method to determine stiffness of lymph nodes, based on the minute deformation of the node by the beating heart. Whether EBUS elastography may further increase the sensitivity to predict the presence or absence of malignancy is unclear.

We suggest to use EBUS elastography strain pattern analysis for this assessment and correlate these measurements with the final pathology outcome to determine NPV, PPV, sensitivity and specificity of this analysis to predict the presence or absence of malignancy in patients with (suspected) lung cancer in a prospectively obtained observational cohort study.

Detailed Description

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Patients will undergo a routine EBUS and/or EUS or EUSb with Pentax series EBUS or EUS scopes in combination with Hitachi Preirus Hi-Vision ultrasound processor with installed elastography software. Normal international guidelines for staging, diagnosis and specimen acquisition will be followed. For a normal evaluation B-mode measurements from all lymph node regions are obtained assessing size and standard ultrasound characteristics and all lymph nodes in the regions of interest that meet the criteria for fine needle aspiration will be sampled. For this study, in addition to the normal B-mode assessment of five sonographic B-mode characteristics elastography strain graph video, elastography image, and a strain histogram from the region of interest will be obtained.

Fine needle aspiration for cytology evaluation will be obtained from nodes based on imaging characteristics or standard sonography characteristics following current everyday clinical practice and the international guidelines. Subsequently, the patient charts will be retrospectively analysed after completion of the diagnostic and/or surgical treatment of the (suspected) lung cancer to match the obtained imaging data to pathology results (cytology and or histology where present) and clinical follow up until 6 months after the diagnostic procedure.

Conditions

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Lung Cancer

Keywords

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NSCLC EBUS elastography predictive value strain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with indication for diagnostic or staging EBUS procedure for suspected or proven lung cancer.
* ASA physical status 1-3.
* Age 18 years or older.

Exclusion Criteria

* Bleeding disorders.
* Contra-indication for temporary interruption of the use of anticoagulant therapy (acenocoumarol, warfarin, therapeutic dose of low molecular weight heparines or clopidrogel).
* Known allergy for lidocaine.
* Uncontrolled pulmonary hypertension.
* Recent and/or uncontrolled cardiac disease.
* Compromised upper airway (eg concomitant head and neck cancer or central airway stenosis for any reason).
* Prior radiotherapy treatment involving the central airways
* ASA classification greater than or equal to 4.
* Pregnancy.
* Inability to consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erik van der Heijden, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

chest physician

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Interventional Pulmonology Unit Policlinico S. Orsola-Malpighi

Bologna, , Italy

Site Status

Azienda Ospedaliera Universitaria di Careggi

Florence, , Italy

Site Status

Ausl Modena - Ospedale Santa Maria Bianca

Modena, , Italy

Site Status

Pesaro-Fano Hospital

Pesaro, , Italy

Site Status

RadboudUMC

Nijmegen, Gelderland, Netherlands

Site Status

Academic Medical Center

Amsterdam, , Netherlands

Site Status

Countries

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Denmark Italy Netherlands

Other Identifiers

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2015-1676

Identifier Type: -

Identifier Source: org_study_id