Endobronchial Ultrasound Guided Transbronchial Aspiration (EBUS-TBNA) in Non Small Cell Lung Cancer (NSCLC) in a Tuberculosis-endemic Country

NCT01156623 | Completed DMC

• 1 other identifier: 98-3639A3
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

In lung cancer with enlarged or non-enlarged mediastinal lymph nodes, contrast-enhanced computed tomography (CT) and Positron emission tomography (PET) scan frequently show discrepancy in tuberculosis-endemic area. Endobronchial ultrasound guided transbronchial aspiration (EBUS-TBNA) with ability of real-time nodal sampling possibly improves the nodal diagnosis. The purpose of this study is to compare the accuracy of nodal diagnosis of contrast-enhanced CT and PET scan with and without EBUS-TBNA, this study will be performed.

Conditions

Non-small Cell Lung Cancer

Keywords

EBUS-TBNA; NSCLC; Mediastinal lymph node; tuberculosis

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  The results of each diagnostic modality were compared with the surgical pathology obtained by thoracotomy and lymph node dissection. The sensitivity, specificity, positive predictive value and negative predictive value of each diagnostic modality were calculated as the standard definition.

  2 weeks

Study Arms (2)

With EBUS-TBNA group

EXPERIMENTAL

The patients enrolled in present study are those with non-small lung cancer and receive contrast-enhanced computed tomography (CT) and Positron emission tomography (PET) with fluorine-18 fluorodeoxyglucose (FDG) examination. In this group, further EBUS-TBNA will be arranged if patients agreed it.

Procedure: EBUS-TBNA

Without EBUS-TBNA group

NO INTERVENTION

The patients enrolled in present study are those with non-small lung cancer and receive contrast-enhanced computed tomography (CT) and Positron emission tomography (PET) with fluorine-18 fluorodeoxyglucose (FDG) examination. In this group, no EBUS-TBNA will be arranged if patients refused it despite we advised it.

Interventions

EBUS-TBNA PROCEDURE

All included patients received TBNA for lymph node study via a flexible ultrasonic bronchoscope with a linear scanning probe on the tip (BF-UC206F-OL8, Olympus). The curved-probe scanned parallel to the insertion direction of bronchoscope, and the obtained images were linked to the ultrasound scanner (EU-2000C, Olympus) incorporated with Doppler-flow imaging. Each lymph node greater than 5mm in short axis measured by cursors was selected for subsequent TBNA with a 22-gauge (NA-201SX-4022, Olympus) needle in a condition of real-time EBUS guidance. A cytology examination was sent for pathologist blinded for the clinical history and image result of patients. When a tissue core was obtained by TBNA, the specimen was also sent for pathology study.

With EBUS-TBNA group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• NSCLC,
• Completed whole body CT or PET scan.

You may not qualify if:

• Pregnancy,
• Age less than 20 years old,
• Other malignancy.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, Taipei, 10507, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Tuberculosis

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Fu-Tsai Chung, M.D.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: June 30, 2010
• First Posted: July 5, 2010
• Study Start: June 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: August 1, 2013
• Last Updated: February 12, 2015

Record last verified: 2015-02

Locations

TW (1)