Randomized study of endobronchial ultrasound (EBUS)-guided transbronchial biopsy (TBB) using 3.4-mm thin bronchoscope vs. EBUS with guide sheath (GS)-guided TBB using 4.0-mm bronchoscope for diagnosis of peripheral pulmonary lesions

Phase 3

• Conditions: Benign or malignant pulmonary lesions

• Registration Number: JPRN-UMIN000000696
• Lead Sponsor: agoya Medical Center

Brief Summary

Background: In endobronchial ultrasound-guided transbronchial biopsy (EBUS-TBB), techniques using a thin bronchoscope or a guide sheath have been proposed for accurate biopsy instrument re-insertion into the bronchial route indicated by a radial ultrasonic probe. The purpose of the present study was to compare the diagnostic yields of these techniques for peripheral pulmonary lesions. Methods: Patients with suspected peripheral pulmonary lesions were included in this prospective, randomized, non-inferiority study and assigned to undergo EBUS-TBB under fluoroscopic guidance using a prototype 3.4-mm thin bronchoscope or a 4.0-mm bronchoscope with a guide sheath. Results: A total of 205 patients were enrolled and randomized, of whom 203 patients (101, thin bronchoscopic method; 102, guide sheath method) were included in the analysis. Diagnostic histologic specimens were obtained in 65% (41% for benign and 75% for malignant lesions) of the thin bronchoscopy group and 62% (25% for benign and 71% for malignant lesions) of the guide sheath group. Diagnostic performance of the thin bronchoscopic method was confirmed to be non-inferior to the guide sheath method (difference in diagnostic yields, 3.6%; 90% confidence interval, -7.5 to 14.7%). Mean procedure time was significantly shorter in the thin bronchoscopy group than the guide sheath group (27 min vs. 33 min; p = 0.002). Complications including pneumothorax, moderate bleeding and pneumonia occurred in 5% and 2% in the respective groups. Conclusions: The diagnostic yields of each method are similar. EBUS-TBB using the thin bronchoscope can be performed more simply and less expensively without a guide sheath, and seems more practical.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-30
• Study Completion: 2010-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

Not provided

Exclusion Criteria

1. Case with serious concomitant medical illness 2. Central pulmonary lesions 3. Diffuse pulmonary lesions 4. Re-examination due to prior failure in this trial 5. Patients who need to undergo other bronchoscopic procedure (e.g. TBNA, BAL) 6. Bleeding tendency 7. Pregnant woman 8. Other clinical difficulties in this trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified