Cryobiopsy-centered Versus Forceps Biopsy-centered Sampling for the Diagnosis of Peripheral Pulmonary Lesions - a Multicenter Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- The overall cumulative diagnostic yield
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Due to the nature of the procedures, blinding is not feasible.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Obtained written informed consent
- •Subjects having <30mm nodule on computed tomography
- •Subjects without contraindication to brochoscopy
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: 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.
干预措施: Transbronchial lung biopsy with radial probe endobronchial ultrasound (Forceps biopsy centered) (Diagnostic Test)
结局指标
主要结局
The overall cumulative diagnostic yield
时间窗: through study completion, an average of 1 year
Pathologic diagnostic yield of primary method and overall procedures
次要结局
- 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)