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Point: Are >50 Supervised Procedures Required to Develop Competency in Performing Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration for Mediastinal Staging? YesMore Than 50 Procedures for EBUS-TBNA? Yes FREE TO VIEW

Erik Folch, MD; Adnan Majid, MD, FCCP
Author and Funding Information

From the Division of Thoracic Surgery and Interventional Pulmonology, Beth Israel Deaconess Medical Center, Harvard University.

Correspondence to: Erik Folch, MD, Beth Israel Deaconess Medical Center, Harvard Medical School, 185 Pilgrim Rd, Deaconess 201, Boston, MA 02215; e-mail: efolch@bidmc.harvard.edu


Financial/nonfinancial disclosures: The authors have reported to CHEST that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2013;143(4):888-891. doi:10.1378/chest.12-2462
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The incidence of lung cancer continues to increase worldwide. The cornerstone of therapy relies on appropriate staging and timely treatment. The Union for International Cancer Control seventh edition TNM classification for lung cancer is based on the retrospective analysis of >80,000 patients with lung cancer treated between 1990 and 2000. This classification uses the TNM to describe the anatomic extent of disease. The objectives of the TNM classification are as follows: help the clinician plan treatment, guide prognosis, assist in treatment evaluation, provide a common language for exchange of information, and contribute to the continued investigation of human cancer.1

In the last 10 years, the techniques of lymph node staging have rapidly evolved from CT scan to PET scan, endoscopic ultrasound-fine needle aspiration (EUS-FNA), convex-probe endobronchial ultrasound-guided transbronchial needle aspiration (CP-EBUS), and, the gold standard, mediastinoscopy. These techniques are considered noninvasive or minimally invasive, and, thus, provide clinical staging. On the other hand, pathologic staging is considered only after surgical resection.2 In the last 5 years, endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) has revolutionized the acquisition of tissue for diagnosis and staging of lung cancer.

The use of CP-EBUS has quickly replaced mediastinoscopy as the staging modality of choice, particularly in academic medical centers. Multiple studies have compared CP-EBUS and mediastinoscopy and have proven the overall sensitivity, specificity, and accuracy to be comparable for both modalities.3,4 Furthermore, the relative ease for the use of CP-EBUS has quickly proliferated among pulmonologists and thoracic surgeons.

Unfortunately, the implementation of such technology has not been accompanied by the necessary safeguards and peer-review process. The familiarity of pulmonologists with flexible bronchoscopy and the relative safety of this procedure gave practicing clinicians access to a needed diagnostic tool. Although current guidelines from the American Thoracic Society/European Respiratory Society and the American College of Chest Physicians recommend a minimum number of 40 to 50 procedures and 20 procedures per year for initial acquisition and maintenance of competency, respectively, most hospitals do not follow these recommendations.5-7

Certainly, we recognize that those recommendations were made before CP-EBUS was widely available and are based on expert opinion, but despite their arbitrary and controversial cutoff values, they constitute an effort to standardize the use of an important procedure. Interestingly, some authors have recently described their learning “from books” and without proctored cases as sufficient.8 Others have recommended a different standard: five proctored cases for thoracic surgeons7 and 20 proctored cases for pulmonologists.9 At the other end of the spectrum lie the interventional pulmonologists who by and large support ≥50 supervised cases. This concern stems in part from the international focus on patient safety and the growing societal pressures to reduce medical errors, particularly in the fields of surgery and interventional procedures.10 We should not forget the beginning of laparoscopic surgery in the late 1980s, described as “the biggest unaudited free-for-all in the history of surgery,” for which the lack of guidelines and credentialing led to the late description of complications and poor outcomes. The interventional pulmonary and thoracic surgery community does not need to reenact mistakes of the past. We are capable of predicting the future and acting preemptively.

Proponents of no minimum standards frequently quote the safety profile of the procedure. However, the most concerning issue is not the periprocedural complications but the consequences of upstaging or downstaging the individual patient. In the former case, the patient will be prevented from receiving potentially curative therapy. In the latter case, the patient may undergo unnecessary surgery and treatments without therapeutic benefit. In the broader sense, the results published by world experts will likely not be replicated by individuals with suboptimal training, which will affect the credibility; thus, CP-EBUS will not be the long-desired “Holy Grail” of mediastinal staging.

The ability of a bronchoscopist to perform an airway examination and basic procedures, such as BAL, transbronchial needle aspiration, and endobronchial and transbronchial biopsy, is not enough for the use of CP-EBUS. The bronchoscopists trained in CP-EBUS should master interpretation of ultrasound imaging, chest anatomy, and endobronchial ultrasound navigation and technique. It is extremely important to have a thorough knowledge of the mediastinal and hilar anatomy and the landmarks that govern the three lymph node maps currently used in the literature. These include the Naruke map, the Mountain-Dresler modification of the American Thoracic Society (MD-ATS) map, and the International Association for the Staging of Lung Cancer lymph node map, including the proposed grouping of lymph node stations into “zones” for prognostic analysis.11

As CP-EBUS has become widely available, and in the absence of formal training, many users do not perform a thorough evaluation of the mediastinum but rather concentrate on a focused examination, guided by the findings of CT or PET scan. Current guidelines from the American College of Chest Physicians and the European Society of Thoracic Surgeons recommend that mediastinoscopy should include exploration and biopsy of representative nodes in five mediastinal lymph node stations (2R, 2L, 4R, 4L, and 7).12,13

Despite the lack of data to demonstrate that a thorough mediastinal staging is superior to selective endobronchial staging, we can extrapolate the available data of pathologic staging at the time of resection. These data suggest that systematic sampling will yield more accurate staging than selective nodal staging.14

Herth et al15 have shown that CP-EBUS can identify micrometastasis in patients with lung cancer and normal mediastinum, defined as lymph nodes <1 cm in short axis in the CT scan. Furthermore, a thorough evaluation of the PET-normal mediastinum yields 9% prevalence of metastatic disease.16

The learning curve required for CP-EBUS is unclear. The British Thoracic Society Guidelines state that every individual has a different learning curve.17 However, the available evidence suggests that results continue to improve up to 120 procedures.18 These results were also seen independently by Medford,19 who described that the diagnostic accuracy continued to improve up to 140 to 160 procedures, and both authors suggest that the learning curve may be longer than expected (Fig 1).

Figure Jump LinkFigure 1. Comparison of EBUS learning curve in two studies.18,19 EBUS = endobronchial ultrasound.Grahic Jump Location

The location and number of lymph nodes affected by cancer have long been used for staging of breast, gastric, and colorectal cancer.20 This is likely to be emulated in lung cancer staging in the future. It is important to point out that interlobar and intralobar lymph sampling have prognostic value, as shown in the seventh TNM classification wherein a subgroup analysis of 28,371 surgically managed patients had pathologic N staging. Significant differences in survival were seen based on clinical staging of nodes, with cN0 having the highest survival at 40 months and rapidly declining to 23 months for cN1, 14 months for cN2, and 9 months for cN3. Unfortunately, further subgroup analysis was complicated by differences between the Naruke and the MD-ATS maps. These maps differ on the nomenclature when defining stations 7 and 10. Under the Japanese map, stations 10R and 10L are those lymph nodes on the medial aspect of the mainstem bronchi, whereas on the MD-ATS map they are considered station 7.

This single difference leads to a discrepancy of IIA vs IIIA for the same lymph node involvement. This highlights the importance of using the same classification and language when we describe our findings. It is planned that the eighth iteration of the TNM classification will assess the prognostic impact of the N status, explore the prognostic impact of involved lymph node zones within N1 and N2 categories, and assess the prognostic impact of single vs multiple station involvement in N1 and N2 locations as well as lymph node size and extrathoracic vs intrathoracic location.21

Detterbeck et al14 described a classification of type and thoroughness of mediastinal staging of lung cancer. In the needle-based type, they describe four levels of thoroughness: complete sampling, systematic sampling, selective sampling, and poor sampling.

Given the devastating consequences of inappropriate staging for lung cancer, we recommend that >50 cases should be proctored before a bronchoscopist is considered to have reached an appropriate level of competency. We should remember that the high sensitivity and specificity described in the literature represent the results of a small selected group of pulmonologists and thoracic surgeons with extensive training and experience with hundreds of cases. If we want CP-EBUS to be held at the highest standard, we should also hold ourselves to the highest standards of care, thoroughness, and reproducibility of the results.

Little et al22 described the wide variability of practice in mediastinoscopy for staging of lung cancer. Only 30% of patients undergoing lung resection underwent mediastinoscopy, and in >50% no lymph nodes were sampled. This variation will likely occur with CP-EBUS when used for staging in the absence of updated guidelines.

We strongly believe that CP-EBUS has opened the door to increase the number of patients who can be staged before surgery. This process should be standardized, and guidelines of thoroughness should be followed. Language used to describe lymph node stations needs to be universal, and we should distinguish between diagnostic CP-EBUS and staging CP-EBUS.

Finally, we would like to recommend that the Centers for Medicare Services review the available research data that support mediastinal staging with CP-EBUS as a cost-effective alternative to mediastinoscopy. At the present time, reimbursement is suboptimal. We strongly believe that creating a different code for a thorough staging that includes N3, N2, and N1 nodes would reflect appropriate reimbursement for time spent and at the same time would be an incentive for thoroughness in staging of lung cancer.

CP-EBUS

convex-probe endobronchial ultrasound-guided transbronchial needle aspiration

EBUS

endobronchial ultrasound

EBUS-TBNA

endobronchial ultrasound-guided transbronchial needle aspiration

EUS-FNA

endoscopic ultrasound-fine needle aspiration

MD-ATS

Mountain-Dresler modification of the American Thoracic Society

Gospodarowicz MK, Miller D, Groome PA, Greene FL, Logan PA, Sobin LH. The process for continuous improvement of the TNM classification. Cancer. 2004;100(1):1-5. [CrossRef] [PubMed]
 
Detterbeck FC, Boffa DJ, Tanoue LT. The new lung cancer staging system. Chest. 2009;136(1):260-271. [CrossRef] [PubMed]
 
Yasufuku K, Pierre A, Darling G, et al. A prospective controlled trial of endobronchial ultrasound-guided transbronchial needle aspiration compared with mediastinoscopy for mediastinal lymph node staging of lung cancer. J Thorac Cardiovasc Surg. 2011;142:1393-1400. [CrossRef] [PubMed]
 
Annema JT, van Meerbeeck JP, Rintoul RC, et al. Mediastinoscopy vs endosonography for mediastinal nodal staging of lung cancer: a randomized trial. JAMA. 2010;304(20):2245-2252. [CrossRef] [PubMed]
 
Ernst A, Silvestri GA, Johnstone D; American College of Chest Physicians American College of Chest Physicians. Interventional pulmonary procedures: guidelines from the American College of Chest Physicians. Chest. 2003;123(5):1693-1717. [CrossRef] [PubMed]
 
Bolliger CT, Mathur PN, Beamis JF, et al. ERS/ATS statement on interventional pulmonology. European Respiratory Society/American Thoracic Society. Eur Respir J. 2002;19(2):356-373. [CrossRef] [PubMed]
 
Block MI. Endobronchial ultrasound for lung cancer staging: how many stations should be sampled?. Ann Thorac Surg. 2010;89(5):1582-1587. [CrossRef] [PubMed]
 
Kupeli E, Memis L, Ulubay G, Akcay S, Eyuboglu FO. Transbronchial needle aspiration (TBNA) by the books [abstract]. Chest. 2010;138(4):432A. [CrossRef]
 
Sheski FD, Mathur PN. Endobronchial ultrasound. Chest. 2008;133(1):264-270. [CrossRef] [PubMed]
 
Aggarwal R, Darzi A. Simulation to enhance patient safety: why aren’t we there yet?. Chest. 2011;140(4):854-858. [CrossRef] [PubMed]
 
Rusch VW, Asamura H, Watanabe H, Giroux DJ, Rami-Porta R, Goldstraw P. The IASLC lung cancer staging project: a proposal for a new international lymph node map in the forthcoming seventh edition of the TNM classification for lung cancer. J Thorac Oncol. 2009;4(5):568-577. [CrossRef] [PubMed]
 
Detterbeck FC, Jantz MA, Wallace M, Vansteenkiste J, Silvestri GA; American College of Chest Physicians American College of Chest Physicians. Invasive mediastinal staging of lung cancer: ACCP evidence-based clinical practice guidelines (2nd edition). Chest. 2007;132(suppl 3):202S-220S. [CrossRef] [PubMed]
 
De Leyn P, Lardinois D, Van Schil PE, et al. ESTS guidelines for preoperative lymph node staging for non-small cell lung cancer. Eur J Cardiothorac Surg. 2007;32(1):1-8. [CrossRef] [PubMed]
 
Detterbeck F, Puchalski J, Rubinowitz A, Cheng D. Classification of the thoroughness of mediastinal staging of lung cancer. Chest. 2010;137(2):436-442. [CrossRef] [PubMed]
 
Herth FJ, Ernst A, Eberhardt R, Vilmann P, Dienemann H, Krasnik M. Endobronchial ultrasound-guided transbronchial needle aspiration of lymph nodes in the radiologically normal mediastinum. Eur Respir J. 2006;28(5):910-914. [CrossRef] [PubMed]
 
Herth FJ, Eberhardt R, Krasnik M, Ernst A. Endobronchial ultrasound-guided transbronchial needle aspiration of lymph nodes in the radiologically and positron emission tomography-normal mediastinum in patients with lung cancer. Chest. 2008;133(4):887-891. [CrossRef] [PubMed]
 
Du Rand IA, Barber PV, Goldring J, et al;; British Thoracic Society Interventional Bronchoscopy Guideline Group British Thoracic Society Interventional Bronchoscopy Guideline Group. British Thoracic Society guideline for advanced diagnostic and therapeutic flexible bronchoscopy in adults. Thorax. 2011;66(suppl 3):iii1-iii21. [CrossRef] [PubMed]
 
Fernández-Villar A, Leiro-Fernández V, Botana-Rial M, Represas-Represas C, Núñez-Delgado M. The endobronchial ultrasound-guided transbronchial needle biopsy learning curve for mediastinal and hilar lymph node diagnosis. Chest. 2012;141(1):278-279. [CrossRef] [PubMed]
 
Medford AR. Learning curve for endobronchial ultrasound-guided transbronchial needle aspiration. Chest. 2012;141(6):1643. [CrossRef] [PubMed]
 
Sobin LH, Gospodarowicz MK, Wittekind C. International Union Against Cancer. TNM Classification of Malignant Tumours.7th ed. Chichester, West Sussex, England: Wiley-Blackwell; 2010.
 
Giroux DJ, Rami-Porta R, Chansky K, et al. The IASLC Lung Cancer Staging Project: data elements for the prospective project. J Thorac Oncol. 2009;4(6):679-683. [CrossRef] [PubMed]
 
Little AG, Rusch VW, Bonner JA, et al. Patterns of surgical care of lung cancer patients. Ann Thorac Surg. 2005;80(6):2051-2056. [CrossRef] [PubMed]
 

Figures

Figure Jump LinkFigure 1. Comparison of EBUS learning curve in two studies.18,19 EBUS = endobronchial ultrasound.Grahic Jump Location

Tables

References

Gospodarowicz MK, Miller D, Groome PA, Greene FL, Logan PA, Sobin LH. The process for continuous improvement of the TNM classification. Cancer. 2004;100(1):1-5. [CrossRef] [PubMed]
 
Detterbeck FC, Boffa DJ, Tanoue LT. The new lung cancer staging system. Chest. 2009;136(1):260-271. [CrossRef] [PubMed]
 
Yasufuku K, Pierre A, Darling G, et al. A prospective controlled trial of endobronchial ultrasound-guided transbronchial needle aspiration compared with mediastinoscopy for mediastinal lymph node staging of lung cancer. J Thorac Cardiovasc Surg. 2011;142:1393-1400. [CrossRef] [PubMed]
 
Annema JT, van Meerbeeck JP, Rintoul RC, et al. Mediastinoscopy vs endosonography for mediastinal nodal staging of lung cancer: a randomized trial. JAMA. 2010;304(20):2245-2252. [CrossRef] [PubMed]
 
Ernst A, Silvestri GA, Johnstone D; American College of Chest Physicians American College of Chest Physicians. Interventional pulmonary procedures: guidelines from the American College of Chest Physicians. Chest. 2003;123(5):1693-1717. [CrossRef] [PubMed]
 
Bolliger CT, Mathur PN, Beamis JF, et al. ERS/ATS statement on interventional pulmonology. European Respiratory Society/American Thoracic Society. Eur Respir J. 2002;19(2):356-373. [CrossRef] [PubMed]
 
Block MI. Endobronchial ultrasound for lung cancer staging: how many stations should be sampled?. Ann Thorac Surg. 2010;89(5):1582-1587. [CrossRef] [PubMed]
 
Kupeli E, Memis L, Ulubay G, Akcay S, Eyuboglu FO. Transbronchial needle aspiration (TBNA) by the books [abstract]. Chest. 2010;138(4):432A. [CrossRef]
 
Sheski FD, Mathur PN. Endobronchial ultrasound. Chest. 2008;133(1):264-270. [CrossRef] [PubMed]
 
Aggarwal R, Darzi A. Simulation to enhance patient safety: why aren’t we there yet?. Chest. 2011;140(4):854-858. [CrossRef] [PubMed]
 
Rusch VW, Asamura H, Watanabe H, Giroux DJ, Rami-Porta R, Goldstraw P. The IASLC lung cancer staging project: a proposal for a new international lymph node map in the forthcoming seventh edition of the TNM classification for lung cancer. J Thorac Oncol. 2009;4(5):568-577. [CrossRef] [PubMed]
 
Detterbeck FC, Jantz MA, Wallace M, Vansteenkiste J, Silvestri GA; American College of Chest Physicians American College of Chest Physicians. Invasive mediastinal staging of lung cancer: ACCP evidence-based clinical practice guidelines (2nd edition). Chest. 2007;132(suppl 3):202S-220S. [CrossRef] [PubMed]
 
De Leyn P, Lardinois D, Van Schil PE, et al. ESTS guidelines for preoperative lymph node staging for non-small cell lung cancer. Eur J Cardiothorac Surg. 2007;32(1):1-8. [CrossRef] [PubMed]
 
Detterbeck F, Puchalski J, Rubinowitz A, Cheng D. Classification of the thoroughness of mediastinal staging of lung cancer. Chest. 2010;137(2):436-442. [CrossRef] [PubMed]
 
Herth FJ, Ernst A, Eberhardt R, Vilmann P, Dienemann H, Krasnik M. Endobronchial ultrasound-guided transbronchial needle aspiration of lymph nodes in the radiologically normal mediastinum. Eur Respir J. 2006;28(5):910-914. [CrossRef] [PubMed]
 
Herth FJ, Eberhardt R, Krasnik M, Ernst A. Endobronchial ultrasound-guided transbronchial needle aspiration of lymph nodes in the radiologically and positron emission tomography-normal mediastinum in patients with lung cancer. Chest. 2008;133(4):887-891. [CrossRef] [PubMed]
 
Du Rand IA, Barber PV, Goldring J, et al;; British Thoracic Society Interventional Bronchoscopy Guideline Group British Thoracic Society Interventional Bronchoscopy Guideline Group. British Thoracic Society guideline for advanced diagnostic and therapeutic flexible bronchoscopy in adults. Thorax. 2011;66(suppl 3):iii1-iii21. [CrossRef] [PubMed]
 
Fernández-Villar A, Leiro-Fernández V, Botana-Rial M, Represas-Represas C, Núñez-Delgado M. The endobronchial ultrasound-guided transbronchial needle biopsy learning curve for mediastinal and hilar lymph node diagnosis. Chest. 2012;141(1):278-279. [CrossRef] [PubMed]
 
Medford AR. Learning curve for endobronchial ultrasound-guided transbronchial needle aspiration. Chest. 2012;141(6):1643. [CrossRef] [PubMed]
 
Sobin LH, Gospodarowicz MK, Wittekind C. International Union Against Cancer. TNM Classification of Malignant Tumours.7th ed. Chichester, West Sussex, England: Wiley-Blackwell; 2010.
 
Giroux DJ, Rami-Porta R, Chansky K, et al. The IASLC Lung Cancer Staging Project: data elements for the prospective project. J Thorac Oncol. 2009;4(6):679-683. [CrossRef] [PubMed]
 
Little AG, Rusch VW, Bonner JA, et al. Patterns of surgical care of lung cancer patients. Ann Thorac Surg. 2005;80(6):2051-2056. [CrossRef] [PubMed]
 
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