Tri-modality Sampling Using Radial Probe Endobronchial Ultrasound for the Diagnosis of Peripheral Pulmonary Lesions

P

Pusan National University

Status

Enrolling

Conditions

Lung Nodule

Treatments

Diagnostic Test: Tri-modality biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT06123312
2310-020-132

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Single intervention arm: Tri-modality biopsy
Experimental group
Description:
Patients enrolled in this single arm will have lung nodules biopsied by Tri-modality (forceps biopsy, needle aspiration, and cryobiopsy)
Treatment:
Diagnostic Test: Tri-modality biopsy

Trial contacts and locations

1

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Central trial contact

Hayoung Seong, MD; Jung Seop Eom, MD, PhD

Data sourced from clinicaltrials.gov

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