Cryobiopsy Vs. Forceps Biopsy for Peripheral Pulmonary Lesions

NCT ID: NCT06752395

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2026-11-01

Brief Summary

This multicenter clinical trial evaluates the diagnostic yields of cryobiopsy and forceps biopsy for peripheral lung nodules. In the cryobiopsy group, cryobiopsy is the primary method, supplemented by forceps biopsy. Conversely, in the forceps biopsy group, forceps biopsy is the primary method, supplemented by cryobiopsy. The study also explores the complementary relationship between the two methods and examines differences in diagnostic rates based on the order in which the procedures are performed.

Detailed Description

This is a multi center, clinical trial evaluating the diagnostic yields of cryobiopsy and forceps biopsy methods used for the biopsy of peripheral lung nodules. In the cryobiopsy group, cryobiopsy is the primary method, with forceps biopsy used as an auxiliary technique, while in the forceps biopsy group, forceps biopsy is the primary method, with cryobiopsy as the auxiliary technique. The study also investigates the complementary relationship between these biopsy methods and evaluates differences in diagnostic rates based on the sequence of the procedures.

Conditions

Lung Cancer (NSCLC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cryobiopsy

Cryobiopsy Group (Primary: Cryobiopsy, Auxiliary: Forceps Biopsy) In this group, cryobiopsy is performed as the primary biopsy method for sampling peripheral lung nodules. After the cryobiopsy is completed, forceps biopsy is conducted as an auxiliary method to obtain additional tissue samples.

Group Type: EXPERIMENTAL

Transbronchial lung biopsy with radial probe endobronchial ultrasound (Cryobiopsy centered)

Intervention Type: DIAGNOSTIC_TEST

When the lung nodule is visualized by bronchoscope using RP-EBUS, cryobiopsy is performed, followed by forceps biopsy.

Forceps biopsy

Forceps Biopsy Group (Primary: Forceps Biopsy, Auxiliary: Cryobiopsy) In this group, forceps biopsy is performed as the primary biopsy method for sampling peripheral lung nodules. Following the forceps biopsy, cryobiopsy is conducted as an auxiliary method to obtain additional tissue samples.

Group Type: EXPERIMENTAL

Transbronchial lung biopsy with radial probe endobronchial ultrasound (Forceps biopsy centered)

Intervention Type: DIAGNOSTIC_TEST

When the lung nodule is visualized by bronchoscope using RP-EBUS, forceps biopsy is performed, followed by cryobiopsy.

Interventions

Transbronchial lung biopsy with radial probe endobronchial ultrasound (Cryobiopsy centered)

When the lung nodule is visualized by bronchoscope using RP-EBUS, cryobiopsy is performed, followed by forceps biopsy.

Intervention Type: DIAGNOSTIC_TEST

Transbronchial lung biopsy with radial probe endobronchial ultrasound (Forceps biopsy centered)

When the lung nodule is visualized by bronchoscope using RP-EBUS, forceps biopsy is performed, followed by cryobiopsy.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Obtained written informed consent
• Subjects having <30mm nodule on computed tomography
• Subjects without contraindication to brochoscopy

Exclusion Criteria

• Patients with central lesions that can be visually confirmed by bronchoscopy or those with suspicious findings of cancer metastasis in the mediastinal lymph nodes, who do not require radial bronchial endoscopic ultrasound (RP-EBUS).
• Patients who cannot discontinue medications that increase bleeding risk, such as antiplatelet agents or anticoagulants.
• Patients with bleeding disorders (e.g., platelet count < 100,000/mm³).
• Patients with severe comorbidities (e.g., serious respiratory or cardiovascular diseases) that make bronchoscopy unsafe.
• Patients with hypersensitivity or allergies to drugs commonly used in endoscopic procedures, including lidocaine, midazolam, fentanyl, or flumazenil.
• Pregnant or breastfeeding patients.
• Patients with confirmed lung cancer undergoing rebiopsy for genetic testing or other purposes.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erbe-med

UNKNOWN

Sponsor Role: collaborator

Pusan National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pusan National University Hospital

Busan, , South Korea

Yeungnam University Medical Center

Daegu, , South Korea

Chungnam National University Hospital

Daejeon, , South Korea

Countries

South Korea

Other Identifiers

2306-027-128

Identifier Type: -

Identifier Source: org_study_id