A Randomized Prospective trial of the Utility of Rapid On-Site Evaluation of Transbronchial Needle Aspirate SpecimensLonny Yarmus, DO,FCCP, Thomas Van der Kloot, MD, Noah Lechzin, MD, Mark Napier,MD, Douglas Dressel, MD, and David Feller-kopman,MD,FCCP J Bronchol Intervent Pulmonol 2011;18:121-127
Background: Previous studies have suggested an increased diagnostik yield for flexible bronchoscopic (FB) transbronchial needle aspirate (TBNA) specimens from lymph nodes when using rapid on-site evaluation (ROSE) by cytophatology Objective: to determine the effect of ROSE on the diagnostic power of TBNA. Methods: The study is a prospective randomized controlled trial.
Introduction FB is the most common modality used to diagnose lung cancer TBNA biopsy is a biopsy technique used during bronchoscopy which involves passing a catheter containing a needle through the trachea or bronchial wall into the lymph nodes or masses to obtain samples for Cytopathologic assesment. Conventional TBNA is a blind procedure in that the structures external to the bronchial wall are not direcly visualized. To addres this concern , ROSE of spesimens has been carried out. .
Introduction With ROSE biopsy material is prepared and stained during the bronchoscopy If the cytopathologist determine that the biopsy was unuccessful, futher TBNA passed can be made during the same procedure, potentially sparing the patient repeated or alternative invasive procedure and their associated risk of complication.
Patient &methods This single centre study used a randomized control designs. The protocol was approved by the Maine Medical Center Institutional. All patients (> 18 years) referred for evaluation of mediastinal or hilar adenopathy and scheduled to undergo FB with TBNA. Eligible patients including those with no mediastinal or hilar adenopathy (short axis,> 1cm) confirmed in the Scan computer tomography of the chest. Sixty-eight patients screened were enrolled.
Patient &methods Patients were randomized at the time of bronchoscopy into the ROSE or the no-ROSE group Before the procedure a subjective pretest clinical probability of malignancy was determined based on the bronchoscopist”s clinical suspicion ( Patient age, tobacco history, medical history, & radiographic imaging) The location of TBNA, number of needle passes size of needle (19 gauge or 22 gauge), duration of procedure,effect of on-site assessment, amount of sedative and topical anasthetic medication used were recorded using a standardized data collection sheet.
The ROSE group had ROSE of TBNA with thePatient & same cytopathologist present during eachmethods procedure with TBNA specimens procedure by a dry smear technique & minimum 3 passes were made at the highest potential ATS nodal station, if no diagnosis, additional passes were allowed & additional procedure could be peformed (brushing, washing& transbrochial biopsy) The no-ROSE: TBNA sample were collected in liquid media and later prepared by cytopathologist & minimum 3 passes maximum 7 passes were made at each ATS nodal station. Then Both ROSE & no ROSE cytopathologic specimen were reviewed by the same attending cytopathologist who was blinded for the final review for all cases
Total of 68 patients with median age of 68 yearsResult (range: 32 to 88 years old) were randomized for the study between February 2005 and July 2006 Table 1: Baseline characteristic patient ROSE NO-ROSE Patient (n) 34 34 Age (y) 70,5 65,5 Male (%) 65 53 Tobacco use (%) 94 91 Median pack years 50 40 High CPM (%) 77 65 Intermediate CPM 12 9 (%) Low CPM (%) 12 27 CPM = clinical probability of malignancy
Table 2: TBNA Anatomic site locations ATS Nodal ROSE NO-ROSE Station 2 1 1 4 12 16 7 23 24 10 4 3 11 0 0 Mass 4 2 ATS=american thoracic society; TBNA: Transbroncial needle aspiration
Table 3: Main Results ROSE NO- P ROSETBNA Diagnostic Yield 56 53 1,0(%)TBNA diagnosis of lung 59 59 1,0neoplasma (%)TBNA diagnosis of any 65 59 0,80neoplasma (%)TBNA adequacy (%) 94 88 0,67
Table 5: Number of Transbronchial BiopsiesPerformed ROSE NON- ROSE Transbronchial biopsies 8 15 performed No transbronchial biopsies 26 19 performed
Both group were followed up for period of up to 2 years after the initial bronchoscopy was performed There are no significant statistical differences in final TBNA diagnosis, final tissue diagnosis, and typed of neoplasma or benign disease diagnosed between the 2 group
Tabel 6: final diagnosis RO Other Diagnostic NO Other Diagnostic Final SE Testing N- TestingDiagnosis TB RO NA SE NSCLC 11 5 (T2, B1, BB1, 12 4 (BB1, V3) TT1) SCLC 3 1 (E1) 4 0 Sarcoid 3 3 (T1,M2) 2 4 (T1, M3)Melanoma 1 0 0 0Lymphom 1 0 0 0 a AFB 0 1(V1) 0 0 True - 6 (M2, V2, C2) - 8 (M2,C6)Negative
DISCUSSION TBNA has become very valuable for the diagnosis and staging of mediastinal use. From ROSE during bronchoscopy has previously been reported to result in improved diagnostic results for TBNA. In a randomized controlled trial comparing prospective ROSE without on-site assessment of Cytopathology (no-ROSE), we found no benefit on the adequacy of the diagnostic results or related to use of the ROSE specimens However, there are chances of decresing number of transbronchial biopsy is needed in the group ROSE.
DISCUSSIONIn this study, the use of ROSE was notassociated with an improved diagnosticyield or specimen adequacy, reduced orincreased procedure time, or withamount of sedation /topical anasthesiarequired and there no difference inmalignancy rates between the ROSEand no-ROSE procedure. Its suggestingthan randomization may haveprevented a preferential use of ROSE inpatients with malignant versus benignlymadenopathy
Conclusion The ROSE procedure should be used on a case by case basis. Larger studies investigating the utility of ROSE on EBUS-TBNA and the incremental yield of EBUS- TBNA over standard TBNA when performed by experienced providers are needed