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(Chest. 2004;125:322-325.)
© 2004 American College of Chest Physicians

Conventional vs Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration*

A Randomized Trial

Felix Herth, MD, FCCP; Heinrich D. Becker, MD, FCCP and Armin Ernst, MD, FCCP

* From the Department of Interdisciplinary Endoscopy (Drs. Herth and Becker), Thoraxklinik, Heidelberg, Germany; and Interventional Pulmonology (Dr. Ernst), Division of Pulmonary and Critical Care Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.

Correspondence to: Armin Ernst, MD, FCCP, Director, Interventional Pulmonology, Pulmonary and Critical Care Division, Beth Israel Deaconess Medical Center, Harvard Medical School, One Deaconess Rd, Boston, MA 02115; e-mail: aernst{at}caregroup.harvard.edu


   Abstract
TOP
 Abstract
Introduction
 Materials and Methods
 Results
 Discussion
 References
 
Study objective: Our group performed a randomized trial to assess whether the addition of endobronchial ultrasound (EBUS) guidance will lead to better results than standard transbronchial needle aspiration (TBNS). EBUS guidance seems to be beneficial in increasing the yield of TBNA but has not been proven to be superior to conventional procedures in a randomized trial.

Methods: Consecutive patients who were referred for TBNA were randomized to an EBUS-guided and a conventional TBNA arm. Patients with subcarinal lymph nodes were randomized and analyzed separately (group A) from all other stations (group B). A positive result was defined as either lymphocytes or a specific abnormality on cytology.

Results: Two hundred patients were examined (100 patients each in groups A and B). Half of the patients underwent EBUS-guided TBNA rather than conventional TBNA. In group A, the yield of conventional TBNA was 74% compared to 86% in the EBUS group (difference not significant). In group B, the overall yields were 58% and 84%, respectively. This difference was statistically highly significant (p < 0.001). The average number of passes was four.

Conclusion: EBUS guidance significantly increases the yield of TBNA in all stations except in the subcarinal region. It should be considered to be a routine adjunct to TBNA. On-site cytology may be unnecessary, and the number of necessary needle passes required is low.

Key Words: bronchoscopy • endobronchial ultrasound • lung cancer • lymph node staging


   Introduction
TOP
 Abstract
 Introduction
Materials and Methods
 Results
 Discussion
 References
 
Transbronchial needle aspiration (TBNA) is a well-established bronchoscopic technique.1 2 It allows for tissue sampling from submucosal layers, from parabronchial and paratracheal lymph nodes and masses, as well as from parenchymal abnormalities. The yield for TBNA varies widely in the literature (ie, 20 to 89%), and seems to be related to the size and location of the lesion, as well as to operator experience.3 4 Additionally, even though TBNA has been proven to be effective for mediastinal lung cancer staging and in some situations may be the only technique yielding positive results,2 it remains underutilized and is not uniformly taught in training programs.5 The employment of rapid on-site cytology (ROSE) is frequently recommended to increase the yield6 and to perform up to seven nodal biopsies.6 Even though effective, this may not be feasible in most hospitals, and ROSE is expensive, as it incurs labor costs and is not appropriately reimbursed.7

There has been significant interest in imaging-assisted TBNA. Procedure guidance with the help of CT fluoroscopy,8 as well as endobronchial ultrasound (EBUS),9 10 has been shown to be feasible and simple to perform. Those studies suggested a significant increase in yield, but they were not randomized and therefore did not compare conventional TBNA directly to image-guided TBNA.

This study was designed to address the question of whether EBUS-guided TBNA is superior to conventional TBNA. EBUS was chosen over CT fluoroscopy as it does not require advanced booking, does not cause any radiation, adds little expense, and can easily be added to any planned bronchoscopic procedure.


   Materials and Methods
TOP
 Abstract
 Introduction
 Materials and Methods
Results
 Discussion
 References
 
Between June 2001 and March 2002, all patients referred for TBNA of enlarged mediastinal lymph nodes were randomized in an EBUS-guided and a conventional TBNA arm. Lymph node stations were classified after the recent American Thoracic Society proposal.11 The trial was approved by the institutional review board, and informed consent was obtained from all patients. No patients were excluded from the trial.

As subcarinal lymph nodes are easily accessible by any method, these patients were randomized and analyzed separately (group A). Patients with lymph nodes in position 2, 3, 4, or aortic-pulmonary window were randomized in group B by computer.

Bronchoscopy was performed in standard fashion either under general anesthesia for combined rigid and flexible examinations or conscious sedation for flexible endoscopy. TBNA and EBUS were performed as detailed below. Indications for TBNA, lesion size on chest CT scan, number of passes, diagnosis, and complications were recorded. EBUS and TBNA were performed by pulmonologists routinely performing both procedures. A positive result was either a specific diagnosis (eg, malignant cells) or a lymphocyte-positive specimen, indicating sampling of the lymph node was successfully achieved.

EBUS
EBUS was performed as previously described in detail.12 13 Through a bronchoscope with 2.8-mm working channel (Olympus Excera and Olympus p 40D; Olympus; Tokyo, Japan), a flexible ultrasound probe with a 20-MHz transducer (UM-2R/3R with driving unit MH-240 and processor EU-M 20 and 30; Olympus) was introduced. The exact location of the target lymph nodes and their relation to the tracheobronchial tree were noted. The probe then was removed from the working channel, and TBNA was performed.

TBNA
TBNA was performed as previously described.2 3 4 Only cytology specimens were obtained with 22-gauge needles (MW 522; Bard; Billerica, MA). The "jabbing" method2 was used for all punctures. Cytology specimens were air-dried on site before being sent to the pathology department. No on-site cytology was used, and the pathologist was unaware of the method used to obtain the specimen.

Statistical Analysis
Means, SEs, and percentages are presented as appropriate. Spearman rank correlation for nonparametric samples was used. Randomization occurred by computer and was designed to detect a 10% difference between the groups.


   Results
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
Discussion
 References
 
Two hundred patients (75 women and 125 men; mean [± SD] age, 51.9 ± 22.6 years) were examined, 100 in each group. The mean lymph node size was 1.76 ± 0.47 cm (range, 0.8 to 4.3 cm) in group A and 1.53 ± 0.43 cm (range, 0.7 to 2.3 cm) in group B. There was no statistical differentiation in demographics between the conventional and the EBUS-guided arm in each group (Table 1 ). The main indications for TBNA were for the diagnosis of enlarged lymph nodes with unknown origin and cancer staging, especially the exclusion of N3 nodes.


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  		Table 1.. Demographics of Groups A and B and Yield of TBNA

 
In group A (subcarinal lymph node), the yield of conventional TBNA was 74% compared to 86% in the EBUS-guided group. If only specific diagnoses were considered, the yield in the conventional arm was 72%, and with EBUS guidance it was 80%. The difference was statistically nonsignificant (p = 0.3). In group B, the overall yield of conventional TBNA was 58% compared to 84% in the EBUS-guided group (Table 2 ). For specific diagnosis only, the yields were 54% and 74%, respectively. The difference was statistically highly significant (p < 0.001) [Table 2 ]. The combined yield for groups A and B was 71% for conventional TBNA vs 80% for EBUS guidance (p < 0.05).


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  		Table 2.. Nodal Stations and Specific Results in Group B*

 
All patients of both groups without a specific diagnosis, irrespective of the presence or absence of lymphocytes in the specimens, underwent a surgical biopsy procedure. No patients with lymphocytes only on TBNA had a more specific diagnosis after surgery. The mean time required for EBUS plus TBNA was 6.3 min, and the mean time for conventional TBNA was 3.8 min (p < 0.05). The average number of needle passes was four. No complications, either related to the procedure or to bronchoscopic damage, were observed with the use of EBUS and/or TBNA.


   Discussion
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
References
 
TBNA is a well-established bronchoscopic technique but remains underutilized, and the yield varies widely.5 This fact may be due to the long learning curve and its associated frustrations. Additionally, conventional TBNA is a fairly blind technique preventing target visualization. This makes accessing smaller lymph nodes and nodes in some locations more difficult. Limited options currently exist to improve yield. The most commonly recommended are ROSE and, recently, the passing of the needle up to seven times into one target.6 ROSE is not available at all institutions and causes practical complications, including scheduling assistance from other departments. It also has been suggested that ROSE is inadequately reimbursed and may cause a financial disincentive for a hospital.7 Also, passing a needle seven times into a nodal target is time-consuming if multiple nodes are being staged and increases the chance of damaging the bronchoscope.

Our study offers an alternative to conventional procedures. EBUS offers a unique way of imaging airway and parabronchial structures during a bronchoscopic procedure.12 13 14 The procedure is safe and minimally invasive, and does not require general anesthesia or hospitalization.13 14 The complication rate is extremely low,13 and several studies10 12 15 have not reported any complications at all. In our study, the addition of EBUS to TBNA added little time but increased the yield significantly in stations other than subcarinal lymph nodes. Those results are equal to or better than the results reported with ROSE or multiple passes up to 7. As expected, the addition of imaging guidance did not contribute to a higher yield in the subcarinal station. It allowed for the reliable biopsy of even small nodes and nodes in difficult locations. This is in contrast to conventional TBNA, where there is a significant difference in diagnostic success, depending on node location and size. Intriguingly, no patient with lymphocytes only received a more specific diagnosis with surgical exploration.

Even though we think that our study clearly demonstrates the benefit of image guidance for TBNA, it needs to be pointed out that the use of EBUS also requires a learning curve and that all operators in this study are highly experienced in its use. Nevertheless, learning the use of EBUS is, in our opinion, to be recommended, as it has proven benefit in many other bronchoscopic procedures, for example therapeutic interventions16 or the evaluation of peripheral lesions.17

A randomized trial of the use of EBUS in the guidance of TBNA procedures has been reported before.18 In that trial, no significant difference was found between EBUS guidance and conventional TBNA. It is noteworthy that in all patients ROSE also was used, potentially masking any benefit of image guidance. Additionally, modern technology allows for significantly better circumferential imaging than the sector scanning ultrasound endoscopy used prior.

We suspect that, with the introduction of dedicated EBUS bronchoscopes for TBNA (which are similar to endoscopic ultrasound endoscopes for the GI tract), the procedure will be even simpler and the yield may be even higher.

In conclusion, EBUS-guided TBNA is superior to conventional TBNA in stations other than the subcarinal space. In our institutions, it has led to a discontinuance of the use of ROSE, and the number of passes rarely exceeds four. As EBUS guidance is so successful, we think that it should be considered a routine adjunct, and in a next step should be compared to mediastinoscopy directly.


   Footnotes
 
Abbreviations: EBUS = endobronchial ultrasound; ROSE = rapid on-site cytology; TBNA = transbronchial needle aspiration

Received for publication March 17, 2003. Accepted for publication July 18, 2003.


   References
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 References
 

  1. Arroliga, AC, Matthay, RA (1993) The role of bronchoscopy in lung cancer. Clin Chest Med 14,87-98[ISI][Medline]
  2. Mehta, AC, Kavuru, MS, Meeker, DP, et al Transbronchial needle aspiration for histology specimens. Chest 1989;96,1268-1272[Abstract/Free Full Text]
  3. Wang, KP, Brower, R, Haponik, EF, et al Flexible transbronchial needle aspiration for staging of bronchogenic carcinoma. Chest 1983;84,571-576[Abstract/Free Full Text]
  4. Gasparini, S, Zuccatosta, L, DeNictolis, M Transbronchial needle aspiration of mediastinal lesions. Monaldi Arch Chest Dis 2000;55,29-32[Medline]
  5. Haponik, EF, Shure, D Underutilization of transbronchial needle aspiration: experiences of current pulmonary fellows. Chest 1997;112,251-253[Abstract/Free Full Text]
  6. Chin, R, Jr, McCain, TW, Lucia, MA, et al Transbronchial needle aspiration in diagnosing and staging lung cancer: how many aspirates are needed? Am J Respir Crit Care Med 2002;166,377-381[Abstract/Free Full Text]
  7. Layfield, LJ, Bentz, JS, Gopez, EV Immediate on-site interpretation of fine-needle aspiration smears: a cost and compensation analysis. Cancer 2001;93,319-322[CrossRef][ISI][Medline]
  8. Garpestad, E, Goldberg, S, Herth, F, et al CT fluoroscopy guidance for transbronchial needle aspiration: an experience in 35 patients. Chest 2001;119,329-332[Abstract/Free Full Text]
  9. Herth, FJF, Becker, HD, Ernst, A Ultrasound guided transbronchial needle aspiration (TBNA): an experience in 242 patients. Chest 2003;123,604-607[Abstract/Free Full Text]
  10. Okamoto, H, Watanabe, K, Nagatomo, A, et al Endobronchial ultrasonography for mediastinal and hilar lymph node metastases of lung cancer. Chest 2002;121,1498-1506[Abstract/Free Full Text]
  11. Mountain, CF, Dresler, CM Regional lymph node classifica-tion for lung cancer staging. Chest 1997;111,1718-1723[Abstract/Free Full Text]
  12. Becker, HD, Herth, F Endobronchial ultrasound of the airways and the mediastinum. Bolliger, CT Mathur, PN eds. Interventional bronchoscopy. Progress in respiratory research 2000;vol 30,80-93 . Basel, Karger:
  13. Herth, F, Becker, HD Endobronchial ultrasound (EBUS): assessment of a new diagnostic tool in bronchoscopy for staging of lung cancer. Onkologie 2001;24,51-154
  14. Kurimoto, N, Murayama, M, Morita, K, et al Clinical applications of endobronchial ultrasonography in lung diseases. Endoscopy 1998;S1,A8-A12
  15. Herth, F, Becker, HD Endobronchial ultrasound of the airways and the mediastinum. Monaldi Arch Chest Dis 2000;55,36-44[Medline]
  16. Herth, F, Ernst, A, Becker, HD Endobronchial ultrasound in therapeutic bronchoscopy. Eur Respir J 2002;20,118-121[Abstract/Free Full Text]
  17. Herth, F, Ernst, A, Becker, HD Endobronchial ultrasound-guided transbronchial lung biopsy in solitary pulmonary nodules and peripheral lesions. Eur Respir J 2002;,972-974
  18. Shannon, JJ, Bude, RO, Orens, JB, et al Endobronchial ultrasound-guided needle aspiration of mediastinal adenopathy. Am J Respir Crit Care Med 1996;153,1424-1430[Abstract]



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