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Correspondence |

A Prospective, Randomized, Double-Blind Trial Comparing the Diagnostic Yield of 21- and 22-Gauge Aspiration Needles for Performing Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration in Sarcoidosis FREE TO VIEW

Valliappan Muthu, MD, DM; Nalini Gupta, MD; Sahajal Dhooria, MD, DM; Inderpaul Singh Sehgal, MD, DM; Amanjit Bal, MD, DM; Ashutosh N. Aggarwal, MD, DM; Digambar Behera, MD; Ritesh Agarwal, MD, DM, FCCP
Author and Funding Information

Drs Muthu and Gupta contributed equally to this manuscript.

FINANCIAL/NONFINANCIAL DISCLOSURES: None declared.

CORRESPONDENCE TO: Ritesh Agarwal, MD, DM, FCCP, Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Sector-12, Chandigarh, India 160012


Copyright 2016, American College of Chest Physicians. All Rights Reserved.


Chest. 2016;149(4):1111-1113. doi:10.1016/j.chest.2016.01.014
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Published online

The diagnostic yield of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in sarcoidosis has been shown to vary from 54% to 93% with a pooled diagnostic accuracy of 79%., It remains unclear whether the use of a larger bore aspiration needle during EBUS-TBNA increases the diagnostic yield in sarcoidosis.,,,, In a prospective, double-blind, randomized controlled trial, subjects with clinicoradiologic suspicion of sarcoidosis were assigned (1:1) to undergo EBUS-TBNA with either a 21- or 22-gauge needle. Endobronchial biopsy and transbronchial lung biopsy (TBLB) were performed at the discretion of the bronchoscopist. The primary outcome was the diagnostic yield (detection of granulomas) of EBUS-TBNA in subjects finally receiving a diagnosis of sarcoidosis. The secondary outcomes were adequacy of samples, granuloma density, and adverse events during the procedure. The study protocol (e-Table 1) was approved by the ethics review committee (1Trg/PG-2014/12543-54), and written informed consent was obtained from all subjects. The trial was registered at www.clinicaltrials.gov (NCT02459431).

During the study period, 151 subjects were randomized to undergo EBUS-TBNA, and sarcoidosis was diagnosed in 143 (Fig 1). The baseline characteristics were similar in the two groups (e-Table 2). Of the 143 subjects with sarcoidosis, granulomas were demonstrated by EBUS-TBNA in 111 (77.6%). There was no difference (Table 1) in the diagnostic yield of EBUS-TBNA between the 21-gauge (77%) and the 22-gauge (78.3%) groups. Of the remaining 32 subjects, 16 were diagnosed according to the results of endobronchial biopsy or TBLB, and 16 were diagnosed on a clinicoradiologic basis. The adequacy of the TBNA aspirate and the granuloma density was also similar in the two groups. A total of 13 (9.1%) complications were observed and did not differ between the two arms. The occurrence of pneumothorax was attributed to TBLB in all cases. There was no occurrence of pneumomediastinum, major hemorrhage, or requirement for ICU admission following the procedure. No deaths occurred in the study.

Figure Jump LinkFigure 1 CONSORT diagram demonstrating the flow of participants in the study. EBB = endobronchial biopsy; TBLB = transbronchial lung biopsy; TBNA = transbronchial needle aspiration.Grahic Jump Location

Table Graphic Jump Location
Table 1 Study Outcomes in Subjects With a Final Diagnosis of Sarcoidosis

Data are presented as no. (%).

TBNA = transbronchial needle aspiration.

To our knowledge, our study is the largest prospective randomized controlled trial comparing 21-gauge needles with 22-gauge needles, and the results suggest that the procedural yield of EBUS-TBNA in sarcoidosis is similar regardless of the aspiration needle size. The lack of difference in the diagnostic yield between the two aspiration needles may be due to the fact that the inner bore of both the needles is reasonably large (the internal diameter of 21- and 22-gauge EBUS-TBNA needles corresponds to 20- and 21-gauge conventional TBNA needles, respectively). Furthermore, because multiple passes are obtained and multiple lymph nodes are generally sampled in sarcoidosis, the total amount of cytologic material obtained is diagnostically sufficient.

Agarwal R. .Srinivasan A. .Aggarwal A.N. .Gupta D. . Efficacy and safety of convex probe EBUS-TBNA in sarcoidosis: a systematic review and meta-analysis. Respir Med. 2012;106:883-892 [PubMed]journal. [CrossRef] [PubMed]
 
Gupta D. .Dadhwal D.S. .Agarwal R. .Gupta N. .Bal A. .Aggarwal A.N. . Endobronchial ultrasound-guided transbronchial needle aspiration vs conventional transbronchial needle aspiration in the diagnosis of sarcoidosis. Chest. 2014;146:547-556 [PubMed]journal. [CrossRef] [PubMed]
 
Nakajima T. .Yasufuku K. .Takahashi R. .et al Comparison of 21-gauge and 22-gauge aspiration needle during endobronchial ultrasound-guided transbronchial needle aspiration. Respirology. 2011;16:90-94 [PubMed]journal. [CrossRef] [PubMed]
 
Oki M. .Saka H. .Kitagawa C. .et al Randomized study of 21-gauge versus 22-gauge endobronchial ultrasound-guided transbronchial needle aspiration needles for sampling histology specimens. J Bronchology Interv Pulmonol. 2011;18:306-310 [PubMed]journal. [CrossRef] [PubMed]
 
Saji J. .Kurimoto N. .Morita K. .et al Comparison of 21-gauge and 22-gauge needles for endobronchial ultrasound-guided transbronchial needle aspiration of mediastinal and hilar lymph nodes. J Bronchology Interv Pulmonol. 2011;18:239-246 [PubMed]journal. [CrossRef] [PubMed]
 
Yarmus L.B. .Akulian J. .Lechtzin N. .et al Comparison of 21-gauge and 22-gauge aspiration needle in endobronchial ultrasound-guided transbronchial needle aspiration: results of the American College of Chest Physicians Quality Improvement Registry, Education, and Evaluation Registry. Chest. 2013;143:1036-1043 [PubMed]journal. [CrossRef] [PubMed]
 
Jeyabalan A. .Shelley-Fraser G. .Medford A.R. . Impact of needle gauge on characterization of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) histology samples. Respirology. 2014;19:735-739 [PubMed]journal. [CrossRef] [PubMed]
 

Figures

Figure Jump LinkFigure 1 CONSORT diagram demonstrating the flow of participants in the study. EBB = endobronchial biopsy; TBLB = transbronchial lung biopsy; TBNA = transbronchial needle aspiration.Grahic Jump Location

Tables

Table Graphic Jump Location
Table 1 Study Outcomes in Subjects With a Final Diagnosis of Sarcoidosis

Data are presented as no. (%).

TBNA = transbronchial needle aspiration.

References

Agarwal R. .Srinivasan A. .Aggarwal A.N. .Gupta D. . Efficacy and safety of convex probe EBUS-TBNA in sarcoidosis: a systematic review and meta-analysis. Respir Med. 2012;106:883-892 [PubMed]journal. [CrossRef] [PubMed]
 
Gupta D. .Dadhwal D.S. .Agarwal R. .Gupta N. .Bal A. .Aggarwal A.N. . Endobronchial ultrasound-guided transbronchial needle aspiration vs conventional transbronchial needle aspiration in the diagnosis of sarcoidosis. Chest. 2014;146:547-556 [PubMed]journal. [CrossRef] [PubMed]
 
Nakajima T. .Yasufuku K. .Takahashi R. .et al Comparison of 21-gauge and 22-gauge aspiration needle during endobronchial ultrasound-guided transbronchial needle aspiration. Respirology. 2011;16:90-94 [PubMed]journal. [CrossRef] [PubMed]
 
Oki M. .Saka H. .Kitagawa C. .et al Randomized study of 21-gauge versus 22-gauge endobronchial ultrasound-guided transbronchial needle aspiration needles for sampling histology specimens. J Bronchology Interv Pulmonol. 2011;18:306-310 [PubMed]journal. [CrossRef] [PubMed]
 
Saji J. .Kurimoto N. .Morita K. .et al Comparison of 21-gauge and 22-gauge needles for endobronchial ultrasound-guided transbronchial needle aspiration of mediastinal and hilar lymph nodes. J Bronchology Interv Pulmonol. 2011;18:239-246 [PubMed]journal. [CrossRef] [PubMed]
 
Yarmus L.B. .Akulian J. .Lechtzin N. .et al Comparison of 21-gauge and 22-gauge aspiration needle in endobronchial ultrasound-guided transbronchial needle aspiration: results of the American College of Chest Physicians Quality Improvement Registry, Education, and Evaluation Registry. Chest. 2013;143:1036-1043 [PubMed]journal. [CrossRef] [PubMed]
 
Jeyabalan A. .Shelley-Fraser G. .Medford A.R. . Impact of needle gauge on characterization of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) histology samples. Respirology. 2014;19:735-739 [PubMed]journal. [CrossRef] [PubMed]
 
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