Cryobiopsy Vs. Forceps Biopsy for Peripheral Pulmonary Lesions

NCT06752395 | Enrolling By Invitation

• 1 other identifier: 2306-027-128
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Lung Cancer (NSCLC)

Keywords

Bronchoscpy; Cryobiopsy; Forceps biopsy; Lung cancer; Radial probe EBUS

Outcome Measures

Primary Outcomes (1)

• The overall cumulative diagnostic yield

  Pathologic diagnostic yield of primary method and overall procedures

  through study completion, an average of 1 year

Secondary Outcomes (5)

• Diagnosis Rate According to Lesion Size

  through study completion, an average of 1 year

• Diagnosis Rate According to Malignant and Benign Disease Classification

  through study completion, an average of 1 year

• Diagnosis Rate According to Bronchus Sign

  through study completion, an average of 1 year

• Diagnosis Rate According to Image Classification Detected by Radial Bronchial Endoscopic Ultrasound (RP-EBUS)

  through study completion, an average of 1 year

• Complication Rate

  through study completion, an average of 1 year

Study Arms (2)

Cryobiopsy

EXPERIMENTAL

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.

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

Forceps biopsy

EXPERIMENTAL

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.

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

Interventions

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

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

Cryobiopsy

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

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

Forceps biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pusan National University Hospital: lead
• Erbe-med: collaborator

Study Sites (3)

Pusan National University Hospital

Busan, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of the procedures, blinding is not feasible.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: December 30, 2024
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)