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A Randomized Prospective trial of the
           Utility of Rapid On-Site Evaluation of
              Transbronchial Needle Aspirate
                         Specimens

Lonny 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 bronchoscopists
                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 the
Patient &       same cytopathologist present during each
methods         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 years
Result        (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
                                ROSE


TBNA Diagnostic Yield     56     53    1,0
(%)


TBNA diagnosis of lung    59     59    1,0
neoplasma (%)


TBNA diagnosis of any     65     59    0,80
neoplasma (%)


TBNA adequacy (%)         94     88    0,67
Table 4: Procedural Data
                     ROSE    NON-ROSE


Aspirates/Site        4,47     4,14
Time(min)             29,5     27,6
Midazolam(mg)         4,38     5,60
Fentanyl(mcg)         107      111
Lidocaine 1%          22,3     22,8
(mL)
Histology needle       38       41
(19 gauge) (%)
Table 5: Number of Transbronchial Biopsies
Performed

                                           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-     Testing
Diagnosis   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          0

Lymphom     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.
DISCUSSION
In this study, the use of ROSE was not
associated with an improved diagnostic
yield or specimen adequacy, reduced or
increased procedure time, or with
amount of sedation /topical anasthesia
required and there no difference in
malignancy rates between the ROSE
and no-ROSE procedure. Its suggesting
than randomization may have
prevented a preferential use of ROSE in
patients with malignant versus benign
lymadenopathy
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
THANK YOU

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Diagnostic power of rose in tbna

  • 1. A Randomized Prospective trial of the Utility of Rapid On-Site Evaluation of Transbronchial Needle Aspirate Specimens Lonny 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
  • 2. 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.
  • 3. 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. .
  • 4. 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.
  • 5. 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.
  • 6. 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 bronchoscopists 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.
  • 7. The ROSE group had ROSE of TBNA with the Patient & same cytopathologist present during each methods 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
  • 8. Total of 68 patients with median age of 68 years Result (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
  • 9. 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
  • 10. Table 3: Main Results ROSE NO- P ROSE TBNA Diagnostic Yield 56 53 1,0 (%) TBNA diagnosis of lung 59 59 1,0 neoplasma (%) TBNA diagnosis of any 65 59 0,80 neoplasma (%) TBNA adequacy (%) 94 88 0,67
  • 11. Table 4: Procedural Data ROSE NON-ROSE Aspirates/Site 4,47 4,14 Time(min) 29,5 27,6 Midazolam(mg) 4,38 5,60 Fentanyl(mcg) 107 111 Lidocaine 1% 22,3 22,8 (mL) Histology needle 38 41 (19 gauge) (%)
  • 12. Table 5: Number of Transbronchial Biopsies Performed ROSE NON- ROSE Transbronchial biopsies 8 15 performed No transbronchial biopsies 26 19 performed
  • 13. 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
  • 14. Tabel 6: final diagnosis RO Other Diagnostic NO Other Diagnostic Final SE Testing N- Testing Diagnosis 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 0 Lymphom 1 0 0 0 a AFB 0 1(V1) 0 0 True - 6 (M2, V2, C2) - 8 (M2,C6) Negative
  • 15. 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.
  • 16. DISCUSSION In this study, the use of ROSE was not associated with an improved diagnostic yield or specimen adequacy, reduced or increased procedure time, or with amount of sedation /topical anasthesia required and there no difference in malignancy rates between the ROSE and no-ROSE procedure. Its suggesting than randomization may have prevented a preferential use of ROSE in patients with malignant versus benign lymadenopathy
  • 17. 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