Cryobiopsy Vs. Forceps Biopsy for Peripheral Pulmonary Lesions

Cryobiopsy-centered Versus Forceps Biopsy-centered Sampling for the Diagnosis of Peripheral Pulmonary Lesions - a Multicenter Prospective Randomized Controlled Trial

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Lung Cancer (NSCLC)
• Intervention / Treatment: Diagnostic test: Transbronchial lung biopsy with radial probe endobronchial ultrasound (Cryobiopsy centered); Diagnostic test: Transbronchial lung biopsy with radial probe endobronchial ultrasound (Forceps biopsy centered)

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Pusan National University Hospital
  • Daegu, Korea, Republic of
    • Yeungnam University Medical Center
  • Daejeon, Korea, Republic of
    • Chungnam national university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The overall cumulative diagnostic yield	Pathologic diagnostic yield of primary method and overall procedures	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis Rate According to Lesion Size	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.	through study completion, an average of 1 year
Diagnosis Rate According to Malignant and Benign Disease Classification	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.	through study completion, an average of 1 year
Diagnosis Rate According to Bronchus Sign	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.	through study completion, an average of 1 year
Diagnosis Rate According to Image Classification Detected by Radial Bronchial Endoscopic Ultrasound (RP-EBUS)	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.	through study completion, an average of 1 year
Complication Rate	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.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Pusan National University Hospital
• Collaborators: Erbe-med

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: December 21, 2024
• First Submitted That Met QC Criteria: December 21, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Lung cancer; Cryobiopsy; Forceps biopsy; Bronchoscpy; Radial probe EBUS
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2306-027-128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No