Cryobiopsy-centered Versus Forceps Biopsy-centered Sampling for the Diagnosis of Peripheral Pulmonary Lesions - a Multicenter Prospective Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 200
- Locations
- 3
- Primary Endpoint
- The overall cumulative diagnostic yield
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Masking Description
Due to the nature of the procedures, blinding is not feasible.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Transbronchial lung biopsy with radial probe endobronchial ultrasound (Cryobiopsy centered) (Diagnostic Test)
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.
Intervention: Transbronchial lung biopsy with radial probe endobronchial ultrasound (Forceps biopsy centered) (Diagnostic Test)
Outcomes
Primary Outcomes
The overall cumulative diagnostic yield
Time Frame: through study completion, an average of 1 year
Pathologic diagnostic yield of primary method and overall procedures
Secondary Outcomes
- 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)