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2016 by the author

Solitary pulmonary nodules: approach options

Stefano GaspariniUniversità Politecnica delle MarcheS.O.D. di PneumologiaAzienda Ospedali RiunitiAncona - Italy

Conflict of interest disclosure

I have no real or perceived conflicts of interest that relate to this presentation.

I have the following real or perceived conflicts of interest that relate to this presentation:

This event is accredited for CME credits by EBAP and EACCME and speakers are required to disclose their potential conflict of interest. The intent of this disclosureis not to prevent a speaker with a conflict of interest (any significant financial relationship a speaker has with manufacturers or providers of any commercial productsor services relevant to the talk) from making a presentation, but rather to provide listeners with information on which they can make their own judgments. It remainsfor audience members to determine whether the speaker’s interests, or relationships may influence the presentation. The ERS does not view the existence of theseinterests or commitments as necessarily implying bias or decreasing the value of the speaker’s presentation. Drug or device advertisement is forbidden.

CLINICAL CASE

- Man, 67 yrs

- History of COPD (FEV1.0 = 47% pred)

- For persistent cough: chest X-ray e CT scan (without c.m.)

TC: spiculated nodule (1.5 cm) of RUL anterior segment

(suspected for malignancy)

CLINICAL CASE

- Bronchoscopy with BAL for cytological evaluation through

right upper lobe bronchus

- No evidence of atypical cells

- A CT guided percutaneous approach is planned

At least three procedural mistakes….

SOLITARY PULMONARY NODULE (SPN)

Single, approximately round and well

circumscribed radiographic opacity which is less or

equal to 3 cm in diameter and which is completely

surrounded by normal aereated lung parenchyma,

without other abnormalities such as lymph node

enlargement, atelectasis or pleural effusion

DEFINITION

ALL SPN: THE SAME APPROACH?

< 1 cm 1-3 cm

GGO

SOLITARY PULMONARY NODULE ?

Problem: Peripheral Pulmonary Lesions (PPL)

CLINICAL CASE

At least three procedural mistakes….

1) CT scan performed without CM

At a careful examination of images, there is the suspect of

a right hilar lymph node enlargement…

SOLITARY PULMONARY NODULE

< 0.8 cm

•Increased identification of small subcentimetric nodules(CT-based screening programmes)

•More than 95% of lesions < 0.8 mm do not represent malignancy(malignancy: 0,2% of nodules < 3 mm, 0.9% of nodules 4-7 mm)(Diederich S. Cancer Imaging 2003; 3: 117)

•Very low sensitivity of PET and biopsy techniques

•Strategy of careful observation with serial CT in patients with nodules < 0.8 cm-Ost D, Fein AM, Feinsilver SH. N Engl J Med 2003; 348: 2353- Guidelines Fleischner Society 2005; ACCP 2013

GUIDELINES FOR MANAGEMENT OF PULMONARY NODULES DETECTED ON CT SCANS:

A STATEMENT FROM THE FLEISCHNER SOCIETY

Size(mm) Low-Risk Patient High-Risk Patient

≤ 4

4 - 6

6 - 8

> 8

No follow-up needed

Follow-up CT at 12 mo;

if unchanged: no further follow-up

Follow-up CT at 6-12 mo.

then at 18-24 mo. if no change

Follow-up CT at 3, 9, and 24 mo;

PET and/or biopsy

Follow-up CT at 12 mo.;

if unchanged, no further follow-up

Follow-up CT at 6-12 mo.,

then at 18-24 mo. if no change

Follow-up CT at 3-6 mo.

then at 9-12 and 24 mo. if no change

Same as for low-risk patients

Radiology, 2005; Chest, 2013

SOLITARY PULMONARY NODULE

Ground glass opacity

• Histotype more frequently responsible for GGO is ADK

• Growth rate of GGO may be slower than solide nodules

(mean volume doubling time = 813±375 days)

(two years stability as a criterion to classify the nodule as benign is not valid)

• GGO < 5 mm don’t require further evaluation

• GGO > 5 mm: annual surveillance with chest CT

(if grow or development of a solid component: resection)

• Part-solid nodule: high incidence of malignancy

(repeat chest CT at 3 months and biopsy/surgery if persists)

SOLITARY PULMONARY NODULE ≥ 8 mm

•Resection without delay of all malignant nodules

•Avoid useless surgery of benign nodulesReduction of risks (1-4% thoracotomy mortality)Reduction of costs

GOAL

Chest 2013; 143(5)(Suppl):e93S-e120S

SOLITARY PULMONARY NODULE

Pretest probability of malignancy

SOLITARY PULMONARY NODULE ≥ 8 mm

When serial CT surveillance is indicated?

(3-6-9-12 and 18-24 months)

• When the clinical probability of malignancy is very low (< 5%)

• When clinical probability is low (30-40%) and the lesion is

not hypermetabolic by PET

• When a fully informed patient prefers this nonaggerssive

management approach

Chest 2013; 143(5)(Suppl):e93S-e120S

SOLITARY PULMONARY NODULE ≥ 8 mm

When nonsurgical biopsy is indicated?

Chest 2013; 143(5)(Suppl):e93S-e120S

SOLITARY PULMONARY NODULE > 0.8 cm

IMMEDIATE SURGERY?

•Resection without delay of all nodules with high probability of

malignancy in patients good candidate for surgery

Pulmonary Unit - Azienda Ospedali Riuniti - Ancona

Jan 1985 - Dec 2000: 1,432 pts with solitary pulmonary nodule

272 (19%): contraindic. for surgery (age, cardioresp. impairment)458 (32%): high risk for surgery160 (11%): suspect of mediastinal lymphonode involvement

98 (6.8%): suspect of metastasis (history of previous cancer)62 (4.3%): surgery without diagnosis refused by the patient

382 (27%): Good candidate for immediate surgery

SOLITARY PULMONARY NODULE

BIOPSY TECHNIQUES

TRANSBRONCHIAL PERCUTANEOUS

The majority of patients needs a biopsy

Is bronchoscopy useful in patients with SPN?

•Arsitizabal et al. Chest 1998; 113: 1244-1249

64 pts with peripheral pulmonary carcinoma Bronchoscopy detected unsuspected endobronchial lesionsin 17% (three of these patients had SPN < 3 cm)

•Schwarz et al. Eur Respir J 2013; 41: 177-182

225 pts with SPNs (88% malignant)Unsuspected endobronchial lesions in 5.5% of pts with cancer

Bronchoscopy changed the planned surgical approach in 5 cases

•Zhang et al. J Thorac Cardiovasc Surg 2015; 159: 36-40

1026 pts with SPNs (80.5% malignant)Unsuspected endobronchial findings in 7.8% Surgery cancelled in 2 and modified in 36 (3.5%) because of bronchoscopic findings

TRANSBRONCHIAL APPROACH:TECHNIQUE OF GUIDANCE

FLUOROSCOPY

TRANSBRONCHIAL APPROACH TECHNIQUES OF GUIDANCE

FLUOROSCOPY EBUS miniprobe

NAVIGATION SYSTEMLUNG POINT

A miniature ultrasound probe

(20 MHz, mechanical-radial Type)

Endoscopic US system

US-probe Catheter

EBUS GUIDANCE: MINIPROBE

Thanks to Ales Rozman

8 mm

Don’t forget radial EBUS (if the nodule is adjacent to larger airways)

ADK

1 cm

ELECTROMAGNETIC NAVIGATION

BRONCHOSCOPY

iLOGIC

ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY

SPiNView navigation systemTransbronchial and percutaneous approach

(Endo/Perc)

F. 75 y

No smoker

GGO first observation

November 2011

CT scan stable after

7 mounths

TBLB with ENB

Adenomatous atipical

hyperplasia

RL lobectomy

Microinvasive

Adenocarcinoma

FLUOROSCOPY EBUS NAVIGATION SYSTEM

• Large availability

• Radiation exposure

• Cheap

(if C-arm fl. available)

• Not all lesions visible

• No radiation exposure

• Expensive (+)

• No radiation exposure

• Expensive (+++)

• No real time visualization

BRONCHOSCOPIC APPROACH TO SPN

Fluoroscopy EMN EBUS

Pts studied

Overall sensitivity

Sensitivityfor SPN < 2 cm

5742

78%

33-58%

260

67%

61%

662

71.2%

60%

Few randomized studies comparing the different guidance techniques

ERJ 2002; 20: 972

50 pts: prospective study

fluoroscopy and EBUS in random

orderNS NS

304 pts

No difference in diagnostic outcome

CLINICAL CASE

At least three procedural mistakes….1) CT scan performed without CM2) Bronchoscopy performed without guidance system

USELESS BRONCHOSCOPY WITHOUT GUIDANCE SYSTEM!Very low sensitivity of BAL: < 10%

In case of SPN: do not perform bronchoscopy if you do not havethe availability of a guidance system!!!

SENSITIVITY OF TRANSBRONCHIAL APPROACH to SPN

37%(Clark et al., 1978)

98%(Ono et Al., 1981)

- Size of the lesion

- Sampling instruments used

- Relationship between the airways and the lesion

- Number of samples

- Time taken

- Operator’s experience

FACTORS AFFECTING RESULTS OF TRANSBRONCHIALAPPROACH TO SPNs

SIZE OF THE LESION

Sensitivity> 2 cm. 76 - 83%< 2 cm. 33 - 58%

Dasgupta A, Mehta AC: Clinics in Chest Medicine, 1999

SAMPLING INSTRUMENTS USED

- Curette- Washing- Biopsy forceps- Brush- Transbronchial needle

Author N. Patients Sampling instruments Sensitivity

Ellis1975

Cortese, Mc Dougall1979

Shure, Fedullo1983

Wang et al1984Gasparini et al1995

Katis et al1995

107

48

42

20

570

37

brushingbiopsybrushing + biopsybrushingbiopsybrushing + biopsybiopsytransbronchial needlebiopsy + needle + brushingbiopsy + brushing transbronchial needlebiopsytransbronchial needlebiopsy + needlewashingbiopsytransbronchial needlewashing+biopsy+needle

42%68%69%40%46%60%36%52%69%25%68%53%69%75%24%38%62%70%

BRONCHUS SIGN:“presence of a bronchus leading to or contained within the nodule”

51 Patients with peripheral pulmonary lesion.20 positive bronchus sign: TBPB positive in 11 (55%)31 negative bronchus sign: TBPB positive in 10 (32%)

FACTORS AFFECTING RESULTS OF TRANSBRONCHIALAPPROACH TO SPNs

SPNs: CT-BRONCHOSCOPIC CORRELATION

Naidich D.P. et Al: Chest 1988; 93: 595-598

117 patientsPresence of bronchus sign only indipendent predictor of all predefinited outcomeSensitivity 87.3%Diagnostic accuracy 86.7%

51 pts with SPN

Diagnostic yield of EMN: 67%

-with bronchus sign: 79%

-without bronchus sign: 31%

ENB diagnostic yield is highly

dependent on the presence of a

bronchus sign on CT imaging

Main factor that limits sensitivity of transbronchial approach to SPN:

lack of a bronchus leading into the lesion

SENSITIVITY

no more than

75-80%

(whichever guidance system)

No way to reach the target!

How to hole this wall?

Thorax 2015; 70: 1-7

Respiration 2016;91:302-306

6 ptsA tunnel pathway was created in 5 (using a set of catheterbased tools)Adequate biopsy in 5 pts2 pneumothorax

TRANSBRONCHIAL APPROACH: ADVANTAGES AND DISADVANTAGES

Information for staging

airways exploration;

TBNA of lymphonodes;

sincronous lung cancer.

Lower incidence of complications (expecially pneumothorax)

Lower value of sensitivity

Higher value of sensitivity (82-90%)

Higher incidence of complications (expecially pneumothorax 15-25%)

No information for staging

PERCUTANEOUS APPROACH: ADVANTAGES AND DISADVANTAGES

CLINICAL CASE

At least three procedural mistakes….1) CT scan performed without CM2) Bronchoscopy performed without guidance system3) Suggested percutaneous approach…(very high risk of pneumothorax in a COPD patient and no information for staging)

CLINICAL CASE

BIOPTIC APPROACH TO SPN

BRONCHOSCOPY

Exploration of upper airwaysand of bronchial tree

Fluoroscopy

If not visible:EMN

TRANSBRONCHIAL BIOPSIES

(3-5)

IMMEDIATECYTOLOGICALEXAMINATION

Immunocyto-chemestry

Electron microscopy

Microbiologicalcultures

InadequateRepeat sampling

Inadequate

PERCUTANEOUS APPROACH(fluoroscopic guidance

without moving the patient)

Diagnostic

STOP

TBNA for mediastinal lymphnode staging

TBNA of the nodule

TBPB TBNA TBPB+

TBNA

PCNA TBPB+

TBNA+

PCNA

52.070.1

77.0

92.8 95.0

SENSITIVITY%

Gasparini S et al, Chest 1995

Integration of transbronchial and percutaneous approachin the diagnosis of SPNs

CONCLUSIONS

•Transbronchial approach, using fluoroscopy or new guidance systems, should

usually be performed before PCNA especially:

- in patients candidate to surgery (staging)

- in patients with impairment of respiratory function

•Please, don’t performe bronchoscopy in cases of SPN if you don’t have a system

of guidance (very low sensitivity of BAL)

•PCNA should be performed when transbronchial technique has failed

•Transbronchial and PCNA: complementary techniques

•The creation of teams able to utilize both approaches at the same time

should be encouraged in order to optimize the diagnostic management of SPN

THANK YOU !

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