Endobronchial Ultrasound Elastography: the Utility of Strain Ratio for Lymph Node Staging in Lung Cancer Patients

The aim of this pilot study is to evaluate EBUS elastography strain ratio in assessment of mediastinal lymph nodes in patients with suspicion for lung cancer for the first time. Strain ratios of mediastinal lymph nodes will be compared with EBUS B-mode features and with tissue diagnosis as a gold standard.

Study Overview

• Status: Completed
• Conditions: Lung Cancer

Detailed Description

Evaluation will be performed on consenting consecutive patients at least 18 years old, referred to bronchoscopy with suspicion for lung cancer according to chest CT-scan. Eligible patients should have either enlarged discrete N2/N3 lymph nodes, or central tumor or enlarged N1 lymph nodes with normal mediastinal lymph nodes. Exclusion criteria will be metastatic disease, severe co-morbidity that disqualified surgical treatment, mediastinal infiltration by tumor and small peripheral lung tumor with normal-sized mediastinal lymph nodes.

Outcomes: Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) for probability of malignant lymph node diagnosis, determined by elastography strain ratio. Receiver operating characteristic (ROC) analysis will be made to display specificity / sensitivity for different strain ratio cut-off values. Area under the ROC curve will be calculated.

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• Slovenia
  • Golnik, Slovenia, 4204
    • University Clinic of Pulmonary and Allergic Diseases Golnik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Consecutive patients at least 18 years old, referred to bronchoscopy with suspicion for lung cancer according to chest CT-scan

Description

Inclusion Criteria:

• enlarged discrete N2/N3 lymph nodes
• central tumor with normal mediastinal lymph nodes
• enlarged N1 lymph nodes with normal mediastinal lymph nodes

Exclusion Criteria:

• metastatic disease
• severe co-morbidity that disqualified surgical treatment
• mediastinal infiltration by tumor
• small peripheral lung tumor with normal-sized mediastinal lymph nodes

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
elastography strain ratio	Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV)	up to 7 months

Collaborators and Investigators

• Sponsor: The University Clinic of Pulmonary and Allergic Diseases Golnik

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: December 4, 2013
• First Submitted That Met QC Criteria: December 8, 2013
• First Posted (Estimate): December 12, 2013

Study Record Updates

• Last Update Posted (Estimate): September 10, 2015
• Last Update Submitted That Met QC Criteria: September 8, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: elastography; endobronchial ultrasound; strain ratio; EBUS - TBNA; lung cancer staging
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: ENDO - 004