Clinical trial of peripheral lung lesion evaluation with radial probe endobronchial ultrasound via an ultraslim bronchoscope and sampling method including a flexible needle

Not Applicable

Recruiting

• Conditions: peripheral pulmonary lesion (PPL); Lung cancer; Respiratory - Other respiratory disorders / diseases; Cancer - Lung - Non small cell

• Registration Number: ACTRN12619000703101
• Lead Sponsor: Dr Gerard Olive

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-10
• Last Update Posted: 27 April 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•Consecutive cases proposed for EBUS GS biopsy of PPL requiring tissue diagnosis at The Prince Charles Hospital
•Adult patients >18 years old
•Capable of providing written informed consent

Exclusion Criteria

•Unacceptably high risk for anaesthetic, bronchoscopy or bleeding
•Pregnancy
•High risk of pneumothorax with needle sampling eg bullous change surrounding lesion
•Biopsy forcep size >1.5mm required

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of procedures demonstrating adequate ultrasound target (concentric or eccentric). Concentric defined as circumferential or greater than 180 degree ultrasound abnormality. Eccentric defined as less than 180 degree ultrasound abnormality.<br>[At time of procedure.];Incremental diagnostic yield of flexible TBNA vs standard of care. Diagnostic yield defined as proportion of cases with definitive diagnosis made on basis of bronchoscopic sampling.[At time of procedure and followup of non-malignant biopsy results at 6-12 months.]