Mobile Cone-Beam CT in Combination With Electromagnetic Navigation Bronchoscopy for the Diagnosis of Peripheral Pulmonary Nodules
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Diagnostic yield improvement ratio
研究概览
简要总结
This study aims to evaluate the clinical value of mobile cone-beam CT (mCBCT) in combination with electromagnetic navigation bronchoscopy for the diagnosis of peripheral pulmonary nodules, and to explore the value of mCBCT in improving the diagnostic yield by calculating the improvement in diagnostic yield of patients before and after mCBCT adjustments.
详细描述
This study is a prospective, single-arm, single-center observational clinical trial to evaluate the diagnostic value of mobile cone-beam CT (mCBCT) in combination with electromagnetic navigation bronchoscopy for the diagnosis of peripheral pulmonary nodules. The investigators will adjust the position of electromagnetic navigation bronchoscopy base on the intraoperative 3D imaging findings of mCBCT. The value of mCBCT in improving diagnostic yield is explored by comparing the diagnostic yield Post-mCBCT with that of Pre-mCBCT. The Pre-mCBCT diagnostic yield is the proportion of patients diagnosed by electromagnetic navigation bronchoscopy and with no need for adjustment after mCBCT spin confirmed "tool-in-lesion" during the procedure in all enrolled subjects. The Post-mCBCT diagnostic yield is the proportion of diagnosed patients with and without adjustment after mCBCT spin during the procedure in all enrolled subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject with age of 18 years and older
- •Chest CT imaging shows the presence of peripheral pulmonary nodules (defined as those lesions that are surrounded by pulmonary parenchyma and located below the segmental bronchus) suspicion of malignancy that need to be confirmed by pathology
- •Pulmonary nodules of > 8mm and ≤30 mm in largest dimension
- •Patients without contraindications of bronchoscopy
- •Patients have good medical adherence and signed informed consent
排除标准
- •Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy
- •Presence of concomitant endobronchial lesion during the bronchoscopy procedure
- •Pre-operative mCBCT spin scan showed no visible lesions
结局指标
主要结局
Diagnostic yield improvement ratio
时间窗: Up to at least 6 months
Diagnostic yield improvement ratio, defined as Post-mCBCT diagnostic yield minus Pre-mCBCT diagnostic yield. The Pre-mCBCT diagnostic yield, defined as the proportion of patients diagnosed by electromagnetic navigation bronchoscopy and without any adjustment after first time mCBCT spin during the procedure in all enrolled subjects. The Post-mCBCT diagnostic yield, defined as the proportion of diagnosed patients including those with and without adjustment after mCBCT spin in all enrolled subjects. Diagnostic yield was defined as all instances in which the results of bronchoscopy matched the final diagnoses.
次要结局
- Adjustment time(Intra-procedure)
- Pre-mCBCT navigational yield(Intra-procedure)
- Fluoroscopy time(Intra-procedure)
- Post-mCBCT navigational yield(Intra-procedure)
- Total operation time(Intra-procedure)
- Factors affecting diagnostic yield(Up to at least 6 months)
- Total radiation dose(Intra-procedure)
- Complication rate(Up to 1 month)
研究者
Jiayuan Sun
Director, Department of Respiratory Endoscopy, Shanghai Chest Hospital
Shanghai Chest Hospital