Clinical trial NCT06123312: Tri-modality Sampling Using Radial Probe Endobronchial Ultrasound for the Diagnosis of Peripheral Pulmonary Lesions
Official title: Tri-modality Sampling Using Radial Probe Endobronchial Ultrasound for the Diagnosis of Peripheral Pulmonary Lesions- A Prospective Observational Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Nodule
Keywords: Radial Probe Endobronchial Ultrasound
Pulmonary Nodule
Forceps Biopsy
Needle Aspiration
Cryobiopsy
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
Collaborators: name: Erbe-med
First posted: 2023-11-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: As the former radial probe endobronchial ultrasound (RP-EBUS) guided transbronchial forceps biopsy of peripheral pulmonary nodules has some limitations, the purpose of this study is to investigate a novel biopsy technique that combines forceps biopsy, needle aspiration, and transbronchial cryobiopsy in patients with peripheral pulmonary nodules.

Detailed description: This is a prospective, single-arm, open-label trial designed to assess the diagnostic accuracy and safety of the Tri-modality (forceps biopsy, needle aspiration, and transbronchial cryobiopsy) biopsy in patients with peripheral pulmonary nodules.

Eligibility criteria: Inclusion Criteria:

* Patient with peripheral lung nodule less than 30mm on CT scan referred for biopsy
* Age ≥ 18
* Written informed consent after participant's information

Exclusion Criteria:

* Central lesion (visible on bronchoscope) or presence of metastatic lymph node (not requiring radial EBUS)
* Pure GGO lesion
* Patients at increased risk of bleeding

  1. Cannot stop agents such as antiplatelet agent or anticoagulant therapy
  2. Coagulopathy: Thrombocytopenia (\< 100,000/mm3) or prolonged PT (INR \> 1.5)
* Patient with existing or risk of pulmonary and cardiovascular decompensation
* Intolerance to sedation
* Vulnerable groups such as pregnant woman, breast feeding, etc.
* Previously diagnosed cancer patient who needs re-biopsy for genetic susceptibility

Primary outcomes:
measure: Diagnostic yield based on pathologic diagnosis
timeFrame: Time Frame: up to 6 months
Secondary outcomes:
measure: Diagnostic yield based on clinical diagnosis
timeFrame: Time Frame: up to 6 months
measure: Adverse events
timeFrame: Time Frame: up to 1 week
Other outcomes:
measure: Radial endobronchial ultrasound probe orientation
timeFrame: Time Frame: up to 1 day
measure: Procedure time in minutes and seconds
timeFrame: Time Frame: up to 1 day
measure: Diameter of cryoprobe
timeFrame: Time Frame: up to 1 day
measure: Number of forceps biopsy
timeFrame: Time Frame: up to 1 day
measure: Number of needle aspiration
timeFrame: Time Frame: up to 1 day
measure: Freezing time of cryoprobe in seconds
timeFrame: Time Frame: up to 1 day
measure: Biopsy size in millimeter
timeFrame: Time Frame: up to 1 month
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University hospital
Study officials:
affiliation: Pusan National University Hospital
name: Jung Seop Eom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: