A Randomized Controlled Trial Comparing the Diagnostic Yield of using Rapid On-Site Cytology Evaluation (ROSE) and without using ROSE in Radial Probe Endobronchial Ultrasound (R-EBUS) Guided Sheath Transbronchial Lung Biopsy with Bronchial Brushing in Peripheral Pulmonary Lesions.

Phase 4

Completed

• Conditions: All patients over the age of 18 who have been scheduled for bronchoscope to get the tissue diagnosis from the peripheral lung lesions at the pulmonary unit, Chulalongkorn Hospital; Rapid on-site cytology evaluation (ROSE), Radial Probe endobronchial ultrasound (RP-EBUS), Transbronchial lung biopsy, Peripheral pulmonary lung lesion, Bronchial brushing, Bronchus sign

• Registration Number: TCTR20230221003
• Lead Sponsor: King Chulalongkorn Memorial hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-11-30
• Study Start: 2023-02-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1. All patients over 18 years old
2.All patients diagnosed with peripheral lung lesions or nodule size smaller than or equal to 3 centimeters from chest computed tomography.

Exclusion Criteria

Patients who have bronchoscopy contraindications
-No consent for the procedure
-Patients do not cooperate during the procedure.
-Risk of hemorrhagic conditions such as Severe Thrombocytopenia (Platelet <20000) , Coagulopathy ( INR < 2) that have not been resolved.
-Severe or refractory hypoxia (SpO2 < 90%)
-Unstable Hemodynamic Status : BP <90/60, MAP < 65, HR < 50 or > 130, RR>30
-Myocardial Infarction within 4-6 weeks
-Patients who increased intracranial pressure
-Severe pulmonary arterial hypertension
-Other relative contraindication conditions depend on judgement of doctor, such as uremia and Superior Vena Cava Obstruction.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
diagnosis yield of peripheral lung lesions or nodules from the use of rapid on-site cytological evaluation (ROSE) during REBUS transbronchial biopsy and brushing in versus the control group. immediately after procedure diagnostic yield of peripheral lung lesion

Secondary Outcome Measures

Name	Time	Method
duration of RP-EBUS, sedative doses, amounts of blood loss of RP-EBUS transbronchial biopsy and brushing in peripheral lung lesions between ROSE group versus control groups. immediate after procedure duration of procedure time, sedative dose, amount blood loss