E- Predict: EBUS ELASTOGRAPHY STRAIN in Lung Cancer

Completed

• Conditions: Lung Cancer

• Registration Number: NCT02488928
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-06-19
• Study First Submitted QC: 2015-06-30
• Study Start: 2015-07
• Study First Posted: 2015-07-02
• Status Verified: 2018-05
• Primary Completion: 2018-07
• Study Completion: 2019-04
• Last Update Submitted: 2019-12-13
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 327

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
stiffness of lymph nodes	participants will be followed for the duration of hospital stay, an expected average of 4 hours	stiffness/strain is a relative measure and has therefor no units

Trial Locations

Locations (7)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Interventional Pulmonology Unit Policlinico S. Orsola-Malpighi; 🇮🇹 Bologna, Italy

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

Azienda Ospedaliera Universitaria di Careggi; 🇮🇹 Firenze, Italy

Pesaro-Fano Hospital; 🇮🇹 Pesaro, Italy

RadboudUMC; 🇳🇱 Nijmegen, Gelderland, Netherlands

Ausl Modena - Ospedale Santa Maria Bianca; 🇮🇹 Modena, Italy