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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.

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.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230221003
Enrollment
68
Registered
2023-02-21
Start date
2022-04-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Once the target site was located, bronchial brushing was done, then cytologist evaluate a cytology by using ROSE.the next step is transbronchial biopsy immediately.Once it has been done 3 times, wheth
Experimental Procedure/Surgery,No Intervention Procedure/Surgery
RPEBUS with bronchial brushing with ROSE,RPEBUS with bronchial brushing

Sponsors

King Chulalongkorn Memorial hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Thailand

Contacts

Public Contactkulchamai kulchamai

Faculty of medicine, Chulalongkorn university

kulchamai19@gmail.com0926694459

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026