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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01156623
First received: June 30, 2010
Last updated: July 2, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
Non-small Cell Lung Cancer
Procedure: EBUS-TBNA

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Value of EBUS-TBNA for Mediastinal Lymph Nodes in Non-small Cell Lung Cancer in a Tuberculosis-endemic Country

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Diagnostic accuracy [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: June 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: With EBUS-TBNA group
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
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.
No Intervention: Without EBUS-TBNA group
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.

Detailed Description:

Lung cancer remains a fatal disease worldwide, and surgical treatment offers possibility for long-term survival. However, the indication and outcome of surgical resection depends on the pre-operative accurate staging and extent of intra-operative lymph node dissection. Therefore, the accurate lymph node staging in non-small cell lung cancer (NSCLC) is crucial for planning optimal treatment. Traditionally, the conventional contrast-enhanced CT essentially identifies enlarged lymph node greater than 1cm as nodal metastasis. Nevertheless, with moderate sensitivity and specificity, contrast-enhanced CT carries substantial risk to under-stage small nodal metastasis and to over-stage inflammatory lymphadenitis.

Positron emission tomography (PET) with fluorine-18 fluorodeoxyglucose (FDG) provides functional images of tumor metabolism, and has been used as a non-invasive alternative other than contrast-enhanced CT for nodal staging in NSCLC. In the absence of detectable lymph node enlargement by CT, FDG-PET scan were increasingly used to stage the lymph node status for NSCLC in some part of world. Hence, the accuracy of FDG-PET might substantially alter the treatment strategy in an institution where the mediastinoscopy is unavailable for lymph node sampling. However, it is generally agreed that abnormal FDG uptake occurred frequently in granulomatous and inflammatory disease. In an endemic area where tuberculosis is still prevalent; such as Eastern Asia, FDG-PET scan has reportedly shown reduced sensitivity and positive predictive value in nodal staging of NSCLC. Thereby, FDG-PET scan alone does not appear to replace mediastinoscopy for nodal staging of NSCLC in a tuberculosis-endemic area, especially in potentially operable patients without enlarged mediastinal lymph nodes.

The recent development of curved ultrasound probe-equipped bronchoscope, which enables direct and real-time aspiration by endobronchial ultrasound- transbronchial needle aspiration (EBUS-TBNA) of mediastinal and hilar lymph nodes, has become an less invasive alternative for nodal staging other than mediastinoscopy. By direct nodal sampling, EBUS-TBNA improves lymph node staging from an image basis to a cytology basis; or even, pathology basis. However, the variable sensitivity and negative predictive value of EBUS-TBNA has been reported, especially in lymph node reduced in size after induction chemotherapy. Nevertheless, reports from NSCLC without significant mediastinal lymph node enlargement on CT otherwise suggested EBUS-TBNA exhibited a high sensitivity and specificity for detecting small nodal metastasis. Therefore, whether EBUS-TBNA retains the reportedly high performance of nodal staging in lung cancer patients without enlarged mediastinal lymph node on CT in a TB endemic country; a condition of FDG-PET scan reportedly showed increased false-positive rate, is still unclear.

In present study, we primarily aim at the comparison of accuracy of nodal diagnosis of contrast-enhanced CT and PET scan with and without EBUS-TBNA in a condition of mediastinal and hilar lymph nodes of lung cancer. Secondarily, we aim at the accuracy of nodal diagnosis by FDG-PET scan in the same condition, and investigate the characteristics of lymph nodes with false PET result.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy,
  • Age less than 20 years old,
  • Other malignancy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156623

Contacts
Contact: Fu-Tsai Chung, M.D. vikingchung@yahoo.com.tw

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Taipei, Taiwan, 10507
Contact: Fu-Tsai Chung       vikingchung@yahoo.com.tw   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Fu-Tsai Chung, M.D. Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Chung Fu-Tsai, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01156623     History of Changes
Other Study ID Numbers: 98-3639A3
Study First Received: June 30, 2010
Last Updated: July 2, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
EBUS-TBNA
NSCLC
Mediastinal lymph node
tuberculosis

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Tuberculosis
Carcinoma, Bronchogenic
Bronchial 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

ClinicalTrials.gov processed this record on August 25, 2014