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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02009319
• Other study ID #: ENDO - 004
• Status: Completed
• Phase: N/A
• First received: December 4, 2013
• Last updated: September 8, 2015
• Start date: August 2013
• Est. completion date: March 2014

Study information

• Verified date: September 2015
• Source: The University Clinic of Pulmonary and Allergic Diseases Golnik
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
Slovenia	University Clinic of Pulmonary and Allergic Diseases Golnik	Golnik

Sponsors (1)

Lead Sponsor	Collaborator
The University Clinic of Pulmonary and Allergic Diseases Golnik

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	elastography strain ratio	Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV)	up to 7 months	No