Cryobiopsy Vs. Forceps Biopsy for Peripheral Pulmonary Lesions

Not Applicable

• Conditions: Lung Cancer (NSCLC)

• Registration Number: NCT06752395
• Lead Sponsor: Pusan National University Hospital

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.

Study Timeline

• Study Start: 2024-11-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-21
• Study First Submitted QC: 2024-12-21
• Study First Posted: 2024-12-30
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Primary Completion: 2025-11-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The overall cumulative diagnostic yield	through study completion, an average of 1 year	Pathologic diagnostic yield of primary method and overall procedures

Secondary Outcome Measures

Name	Time	Method
Diagnosis Rate According to Lesion Size	through study completion, an average of 1 year	This outcome measures the diagnostic success rate based on the size of the peripheral lung nodule. Lesions are categorized by size (e.g., \<20 mm, 20 mm-30mm) to determine whether lesion size affects the accuracy and success of the biopsy method.
Diagnosis Rate According to Malignant and Benign Disease Classification	through study completion, an average of 1 year	This measures the diagnostic yield of cryobiopsy and forceps biopsy by differentiating between malignant and benign lesions. The diagnostic rate is compared between cases of cancerous and non-cancerous nodules to assess the performance of the biopsy methods in each category.
Diagnosis Rate According to Bronchus Sign	through study completion, an average of 1 year	The bronchus sign refers to whether or not the lesion is connected to a bronchus, as seen on imaging. This outcome evaluates whether the presence or absence of a bronchus sign impacts the diagnostic success of the biopsies.
Diagnosis Rate According to Image Classification Detected by Radial Bronchial Endoscopic Ultrasound (RP-EBUS)	through study completion, an average of 1 year	This outcome assesses the diagnostic rate based on the characteristics of the lesion as identified by RP-EBUS imaging (e.g., solid, partially solid, or ground-glass opacities). The study evaluates whether different imaging characteristics influence the biopsy's diagnostic accuracy.
Complication Rate	through study completion, an average of 1 year	This outcome measures the incidence of complications (e.g., bleeding, pneumothorax) that occur during or after the biopsy procedure. The complication rates are compared between the two biopsy methods to evaluate their safety profiles.

Trial Locations

Locations (3)

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of

Yeungnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of