Chest
Volume 128, Issue 5, November 2005, Pages 3551-3557
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Bronchoscopy
Endobronchial Ultrasound-Driven Biopsy in the Diagnosis of Peripheral Lung Lesions

https://doi.org/10.1378/chest.128.5.3551Get rights and content

Study objectives: The aim of our study was to compare the diagnostic yield of two bronchoscopic procedures: endobronchial ultrasound-driven transbronchial biopsy (EBUS-TBB) and transbronchial biopsy (TBB) in peripheral pulmonary lesions.

Design: Prospective, randomized, blinded study.

Setting: University Hospital of Rome, Italy

Patients and methods: We examined 799 patients with peripheral lung lesions using bronchoscopy. Patients who could undergo a complete clinical diagnostic follow-up (n = 293) were enrolled in the study and randomly assigned to EBUS-TBB or TBB. We performed these two procedures on 221 patients (97 EBUS-TBB and 124 TBB). Patients in whom biopsies were not diagnostic underwent more invasive procedures to obtain a final diagnosis, and a complete follow-up was possible in 206 patients (87 EBUS-TBB and 119 TBB).

Results: Lung cancer was diagnosed in 61 patients in the EBUS-TBB group and in 83 patients in the TBB group. Pulmonary diseases other than cancer were diagnosed in 26 patients and 36 patients, respectively. For patients with lung cancer, sensitivity was 0.79 in the EBUS group and 0.55 in the TBB group (p = 0.004), and accuracy was 0.85 and 0.69, respectively (p = 0.007). The analysis of a subset of patients with lesions > 3 cm showed no significant difference in diagnostic ability between the two procedures. In lesions < 3 cm, we found a considerable decline in TBB sensitivity and accuracy (0.31 and 0.50) while EBUS-TBB maintained their diagnostic yield (0.75 and 0.83) [p = 0.0002 and p = 0.001, respectively]. A similar difference was observed when we compared the sensitivity of the two procedures in lesions < 2 cm (0.23 vs 0.71, p < 0.001).

Conclusions: EBUS-TBB can be an important option in the early diagnosis of peripheral lung cancer, especially in small-sized lesions and in patients who are not eligible for surgery.

Section snippets

Study Population

From January 2001 to September 2003, 3,184 consecutive unselected patients with suspected lung cancer were referred to our center of thoracic endoscopy for diagnostic bronchoscopy. Patients with peripheral lung lesions were investigated by means of chest CT.

We screened 799 patients with peripheral lung lesions; 506 patients were ineligible because they did not satisfy the inclusion criteria (Fig 1). Among the ineligible patients, we excluded 386 outpatients because of previously experienced low

RESULTS

Table 1shows the characteristics of the 206 patients evaluated in our study. Typical findings observed are shown inFigure 2. A definitive diagnosis was obtained by EBUS-TBB in 66 of 87 patients (75.8%) and by TBB in 62 of 119 patients (52.1%). In the study group, the diagnostic yields of EBUS-TBB were 69.2% (18 of 26 benign lesions) and 78.7% (48 of 61 malignant lesions). In the control group, the diagnostic yields of TBB were 44.4% (16 of 36 benign lesions) and 55.4% (46 of 83 malignant

DISCUSSION

The role of bronchoscopy in the diagnosis of small-sized peripheral lung lesions is controversial. Its sensitivity is low, and a negative result cannot rule out the presence of a malignancy. The possibility of using ultrasound has widened the bronchoscopic vision beyond the bronchial wall, with a substantial increase in diagnostic sensitivity.11

While the role of EBUS-driven biopsies in central malignancy diagnosis or in the evaluation of lymph nodes involvement is well established, there are

ACKNOWLEDGMENTS

We thank Dr. June Traicoff (20/20 GeneSystem, Inc, Rockville, MD), Professor Giovanni Schmid (C.U.B.E. Department of Cardiovascular and Respiratory Sciences, University of Rome La Sapienza, Forlanini Hospital, Italy), Dr. Enrico Girardi (Department of Epidemiology, National Institute for Infectious Diseases, IRCCS Lazzaro Spallanzani, Rome, Italy) for helpful discussion and critical review of the manuscript; and Dr. Andrea Stoler for text revision.

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      Stratification and meta-regression (for continuous variables) failed to demonstrate an association between reported sensitivity and single vs multicenter status, randomized vs prospective vs retrospective studies, consecutive case enrollment, prevalence of lung cancer, percentage of patients with bronchus sign, fluoroscopy use, guide sheath use, average lesion size, virtual bronchoscopy use, and follow-up time. Studies that used ROSE27-31 had a higher pooled sensitivity than studies that did not use ROSE6,25,26,32-78 (sensitivity, 0.79; 95% CI, 0.74-0.84 vs 0.72; 95% CI, 0.69-0.74, respectively; between-group heterogeneity P = .01) (e-Fig 5). Smaller studies (≤ 50 patients undergoing r-EBUS) had a higher sensitivity than larger studies (sensitivity, 0.78; 95% CI, 0.75-0.82 vs 0.70; 95% CI, 0.67-0.73, respectively; between-group heterogeneity P < .01) (e-Fig 6).

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