Dx Mediastinal Malignant LAP:Compare PET and EBUS-TBNA

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01367366
First received: May 20, 2010
Last updated: June 6, 2011
Last verified: May 2011
  Purpose

Lung cancer is the leading cause of death in Taiwan. The outcomes of the disease vary depending on early detection, histologic types and staging. Because the mediastinal involvement including lymph node status is a significant prognostic factor for survival, lymph node biopsy is necessary for clinical staging of some patients. Although fluorodeoxyglucose-positron emission tomography (FDG-PET) is suggested for precise evaluation of mediastinum, tissue proof of PET positive lesions are recommended due to its limited diagnostic specificity for identifying mediastinal metastases. Cervical mediastinoscopy remains the "gold standard" for mediastinal lymph node sampling. However, it is invasive, requires general anesthesia. Another new minimally invasive method of mediastinal biopsy is real-time endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). The aim of this study is to compare the accuracy of PET and EBUS-TBNA for correct staging of the mediastinum for lung cancer patients.


Condition Intervention
Mediastinal Lymphadenopathy
Procedure: PET and EBUS-TBNA

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Dx Mediastinal Malignant LAP:Compare PET and EBUS-TBNA

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Diagnostic value of PET and EBUS-TBNA [ Time Frame: 1 week ] [ Designated as safety issue: No ]

    Thg diagnostic criteria for malignant mediastinal lymphadenopathy is as followed:

    1. EBUS-TBNA: postive cytology or patholoy result of the culprit lymph node
    2. PET: SUVmax >2.5 of the culprit lymph node

    The gold standard diagnostic method is surgical biopsy of the culprit lymph node.

    The sensitivity,specificity,positive and negative predictive value will be calculated.



Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Mediastinal malignant lymphadenopathy Procedure: PET and EBUS-TBNA
PET and EBUS-TBNA once, respectively

Detailed Description:

Lung cancer ranks among the most commonly occurring malignancies and currently is the leading cause of cancer-related cause worldwide including Taiwan [1, 2]. Although a lot of research focus on the treatment of lung cancer, the prognosis of lung cancer remains dismal and a five year survival ate is less than 15% [3]. Unfortunately, early detection of lung cancer is still a problem. In a tertiary care hospital in Taiwan, only 27.3% of patients could received operation (stage I 15%, stage II 7.5%) [4]. Lymph node staging is also important for evaluation the possibility of operation.

Fluorodeoxyglucose-positron emission tomography (FDP-PET) is now used by oncologist to evaluate lung masses, solitary pulmonary nodules and intrathoracic lymph nodes. As the technique becomes more widespread, it is now used even as a first line imaging investigation. Although PET has a high negative predictive value, it is neither sensitive nor specific to differentiate benign from malignant mediastinal lymph nodes [5, 6]. If PET positive mediastinal lymph nodes are equal to malignant involvement, some patients might be excluded from potentially curative surgery. Several national guideline groups suggest that PET positive lymph nodes should be biopsied if it is likely that the result will alter clinical management [7, 8].

"Cervical mediastinoscopy" has been regarded as the "standard procedure" for sampling mediastinal lymph nodes. However, these techniques require general anesthesia and could not be repeated because of adhesion. Access to hilar nodal stations can be difficult for mediastinoscopy. In recent years, one minimally invasive method endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was used for biopsy of both hilar and mediastinal lymph nodes [9]. EBUS-TBNA allows the mediastinal lymph nodes to be targeted in the areas accessible to cervical mediastinoscopy, as well as some hilar nodes (lymph node stations 2-4, 7, 10-12)[9] .

Kazuhiro Yasufuku had published the first report of real-time EBUS-TBNA in evaluating mediastinal lymphadenopathy in 2004 [10]. Currently, the main indication of EBUS-TBNA is the mediastinal nodal staging of NSCLC after recent meta-analyses established the comparable sensitivity and specificity of nodal staging by EBUS-TBNA and cervical mediastinoscopy [11]. Efficacy in evaluation of other disease processes such as sarcoidosis and lymphoma has also been established [12].

Although there were several large studies to compare the diagnostic efficacy of mediastinal malignant lymphadenopathy between FDG-PET and EBUS-TBNA, the investigators need to have our own data because of high incidence of TB lymphadenitis in Taiwan, where the diagnostic accuracy of PET may be lower than other countries.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Suspected malignant mediastinal lymphadenopathy

Criteria

Inclusion Criteria:

  1. Age older than 18 years
  2. Patient with suspected malignant mediastinal lymphadenopathy

Exclusion Criteria:

  1. Age younger than 18 years
  2. Bleeding diathesis(INR > 1.4, Platelet count < 10,000/mcl)
  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: NCT01367366

Contacts
Contact: Chao-Chi Ho, PhD 886-972651317 ccho1203@gmail.com

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chao-Chi Ho, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Chao-Chi Ho/MD,PhD, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01367366     History of Changes
Other Study ID Numbers: 201004018R
Study First Received: May 20, 2010
Last Updated: June 6, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
malignant mediastinal lymphadenopathy
positron emission tomography
endobronchial ultrasound
transbronchial needle aspiration

Additional relevant MeSH terms:
Lymphatic Diseases

ClinicalTrials.gov processed this record on August 20, 2014