EBUS – Mediastinal Staging

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2016 Duke Masters of Minimally Invasive Thoracic Surgery Sep 15-17th, 2016

Kazuhiro Yasufuku MD, PhD

Director of Endoscopy, University Health Network

Director, Interventional Thoracic Surgery Program

Associate Professor of Surgery, University of Toronto

Division of Thoracic Surgery, Toronto General Hospital

Disclosure

• Industry-sponsored grants • Educational and research grants from Olympus Corporation

• Consultant • Olympus America Inc.

• Intuitive Surgical Inc.

• Covidien

• Johnson and Johnson

• Research Collaboration • Siemens

• Novadaq Corp.

• Veran Medical Systems

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Mediastinal Staging

• Non-invasive staging (Imaging) • CT, PET-CT

• Invasive staging (Tissue diagnosis) • Surgical biopsy (Med, VATS)

• Needle biopsy (TBNA, EBUS-TBNA, EUS-FNA, TTNA)

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Endoscopic Staging - EBUS-TBNA

• Access to all LN stations accessible by Med as well as N1 nodes

• A minimally invasive modality

• Sensitivity 85-96%

• Real time procedure

• Doppler mode enables differentiation of LN from vessels

• Adopted in over 2500 centers

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Hanna WC, Yasufuku K. Ther Adv Respir Dis. 2013; 7(2): 111-8

Convex Probe EBUS (Olympus)

Outer Diameter: 6.9 mm Scanning Range： 50 degrees Instrument Channel： 2.2 mm Optics： 35 degrees forward oblique

Division of Thoracic Surgery Toronto General Hospital

Convex Probe EBUS (Olympus)

Division of Thoracic Surgery Toronto General Hospital

EBUS-TBNA – Equipment (Olympus)

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EU-ME1

EU-C60 EU-ME2

EBUS - EB1970UK (Pentax Medical)

• 19 French

• 6.3mm Insertion Tube

• 2mm working channel

• Color CCD video images

• 45⁰ Forward Oblique

• Hitachi 5500 scanner

• 75⁰ Forward Oblique

• 5,6.5,7.5,9, 10 MHz options

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New Small Hitachi Linear Array Ultrasound Transducers

EBUS scope – EB-530US (FUJIFILM)

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Fujifilm Ultra Small Super CCD Chip

installed

10°forward oblique view

Wide Field of View: 120°

Φ6.3mm

Φ6.7mm

Φ2.0mm

NA-201SX-4022, 4021 (Olympus)

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21G and 22G needles

SonoTip EBUS Pro Flex (Medi-Globe)

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Dimensionally stable 22G Nitinol needle

Eliminates needle deformation

EchoTip ProCore EBUS Needles (Cook Medical)

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Core trap design to obtain tissue

22G and 25G

ExpectTM EBUS-TBNA Needles (Boston Scientific)

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22G and 25G

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Cell blocks often contain a “mini-core” of tumour.

Can be used for multiple immunohistochemical stains.

Can provide prognostic information (cell-cycle proteins, EGFR mutation).

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EBUS-TBNA

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Understanding the Mediastinum

Bronchoscopic Anatomy

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Carina

SVC

Esophagus

Azygos vein

Descending Aorta

Lt Upper Lobe Br

Lt Lower Lobe Br

Rt Upper Lobe Br

Tr Intermedius

PA

Ascending Aorta

A1,3

A3

A1+2 a,b

A1+2 c

A6

#3p #3p

#10

#10

#4L #4R

#10

#5

#6

#7

#4R

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Carina

#4R

#7

SVC

Azygos vein

Ascending Aorta

#4L #4R

PA

Descending Aorta

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Rt Main Bronchus

SVC

PA

Asc Aorta

Azygos Vein

＃4R

＃７

＃１０R

＃１１

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Rt Main PA

Rt SPV

Tr Intermedius

Rt Main Br

Rt Upper Lobe Br ＃７

Carina

＃１０Ｒ ＃１２

＃１０Ｒ

＃１１

Ａ１

Ａ３

Ｂ１

Ｂ２

Ｂ３ Ｖ２

Ｖ３

Ｖ３

Rt Upper / Tr Intermedius

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Rt Upper / Tr Intermedius

#１２Ｒ

#１１Ｒ

#１０Ｒ

Rt Upper Lobe Br

Rt Lower Lobe Br

Rt Main stem PA

SPV

A１ A２ A３

V１,２ V３

V４,５

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Rt Middle and Lower Lobe Br

Rt Main PA

Ａ６ｂ,ｃ

Ａ５

Ａ４

Ａ６ａ

Basalis PA

Rt IPV

Ｖ４,５

＃１２Ｒ

＃１２Ｒ

＃１０

＃１１Ｒ

＃１３

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Lt Main Br

Descending Aorta

Lt Lower Lobe Br

B1+2,3

Ascending Aorta

A3＋A1+2a,b

A1+2 c

#10Ｌ #4L

#5

#6

#7

B4,5

A6

A4,5

Lt Main PA

＃11

Basal A

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Lt Main Br

Aorta

Lt Main PA

＃７

＃4L

＃１０Ｌ

A3＋A1+2a,b

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Lt Upper / Lower

Lt Lower Lobe Br

B1+2 A3＋A1+2a,b

#12Ｌ

#12Ｌ #13

#10Ｌ

B4

A6

A4,5

Lt Main PA

＃11Ｌ

Basal PA

B3

B5

#13

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Lt Upper / Lower

Lt Main PA

Lt SPV

Lt IPV

＃１０Ｌ

＃１０

＃１１Ｌ

＃１２

＃１２Ｌ

＃１３

Ａ６

Ａ４,５

Ａ１＋２ｃ

Ａ８

A3＋A1+2a,b

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Trachea

＃2L ＃4R

＃2L

＃2R

SVC Rt BCV

Lt BCV Rt BCA

Lt SCA

Aorta Azygos vein

＃２Ｒ

Understanding the Mediastinum

EBUS Anatomy

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Stations 4R and 4L

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#4R

#7

SVC

Azygos vein

#4L #4R

PA

#10R

Stations 4R and 10R

Stations 4R, 2R and 2L

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Stations 7 and 11R

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EBUS-TBNA for Lung Ca Staging

• EBUS-TBNA Systematic Review and Meta-analysis • 22 studies

• >2000 patients

• Sensitivity: 0.88-0.93 (95% CI 0.79-0.94)

• Specificity: 1 (95% CI 0.92-1)

• Equivalent to Mediastinoscopy sensitivity, NPV, diagnostic accuracy

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Gu P. et al. Eur J Ca. 2009;45:11389-96 Adams K. et al. Throax. 2009;64:757-62

Zhang R. et al. Eur J Ca. 2013;49:1860-67

Lung ca staging (EBUS vs Med)

• Prospective cross-over trial (Ernst et al)

• Disagreement in the yield for #7 (24%; p=0.011)

• Prospective controlled study (Yasufuku et al)

• No difference between EBUS and Med

• Prospective controlled study (Um et al)

• EBUS superior to Med in sensitivity, accuracy and NPV (p<0.005)

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Ernst et al. J Thorac Oncol. 2008; 3: 577-82 Yasufuku et al. J Thorac Cardiovasc Surg. 2011 142: 1393-1400

Um SW et al. J Thorac Oncol. 2015; 10(2): 331-7

Sensitivity NPV

Study Year Number Prevalence of N2/N3 EBUS Med EBUS Med

Ernst et al 2008 66 89 87 68 78 59

Yasufuku et al 2011 153 32 81 79 91 90

Um et al 2015 127 59 88 81 85 79

Lung ca staging (EBUS vs VAM) – meta-analysis

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Ge Xet al. Lung. 2015; [Epub ahead of print]

• Quantitative meta-analysis of EBUS-TBNA (n=10) and VAM (n=7)

• Meta-regression applied after adjusting quality score, study design and LN station number

• Sensitivity

• EBUS 0.84 (95% CI 0.79-0.88) vs VAM 0.85 (95% CI 0.82-0.88)

• More procedural complications and fewer false negatives with VAM than EBUS

• EBUS-TBNA should be performed first, followed by VAM in the case of a negative needle result

Cost Effectiveness

• A decision-tree analysis to compare downstream costs of EBUS-TBNA, conventional TBNA and mediastinoscopy.

• EBUS-TBNA (-ve results surgically confirmed) most cost-beneficial approach (AU$2961)

• EBUS-TBNA (-ve results not surgically confirmed) ($3344)

• Conventional TBNA ($3754)

• Mediastinoscopy ($8859)

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Steinfort et al. J Thorac Oncol. 2010;5: 1564–1570

Changes of ACCP Guidelines – Mediastinal Staging

• 2007 ACCP Guidelines

• Mediastinoscopy is generally preferable because of the higher FN rates of needle techniques in the setting of normal-sized lymph nodes

• A non-malignant result from a needle technique (eg, EUS-NA, TBNA, EBUS-NA, or TTNA) should be further confirmed by mediastinoscopy

• 2013 ACCP Guidelines

• In patients with high suspicion of N2,3 involvement, a needle technique (EBUS-NA, EUS-NA or combined EBUS/EUS-NA) is recommended over surgical staging as a best first test (Grade 1B)

• Remark: In cases where the clinical suspicion of mediastinal node involvement remains high after a negative result using a needle technique, surgical staging (eg, mediastinoscopy, VATS, etc) should be performed

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Advantages of EBUS over Med

• Outpatient setting under local anesthesia • Absence of neck scar • Access to N1 nodes • Less risk of morbidity • Less healthcare costs • Potential to streamline thoracic surgical capacity • Avoids unnecessary surgery in pts with infiltrating

mediastinal disease

Hanna W, Yasufuku K . Curr Respir Care Rep 2013

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De Leyn P et al. Eur J Cardiothorac Surg 2014;45:787-798

Revised ESTS guidelines for mediastinal staging

Summary • Accurate staging of the mediastinum remains essential for

management of patients with NSCLC

• The value of EBUS-TBNA as a diagnostic tool for LN staging of NSCLC has been established

• Understanding the anatomy of the mediastinum and the hilum is essential for performing a successful EBUS-TBNA

• EBUS-TBNA may be considered the first line procedure for pts with NSCLC with radiologic evidence of mediastinal adenopathy

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Thank you

Division of Thoracic Surgery

Toronto General Hospital

University Health Network

Kazuhiro Yasufuku, MD, PhD, FCCP

kazuhiro.yasufuku@uhn.ca