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 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.
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
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
