Application Value of Respiratory Mediastinal Intervention Technique in Diagnosis and Comprehensive Treatment of Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- In the diagnosis of mediastinal diseases, the difference in diagnosis rate between the experimental group with open mediastinum and the control group with traditional methods was observed
研究概览
简要总结
The goal of this observational study is to learn whether patients undergoing mediastinal disease diagnosis and combined treatment with intrapacial ultrasound-guided mediastinal opening techniques have greater clinical benefit.
The main questions it aims to answer are:
- Whether the mediastinal ultrasound-guided mediastinal opening technique is more beneficial for the diagnosis of benign or malignant mediastinal diseases.
- Does the mediastinal ultrasound-guided mediastinal opening technique benefit the patient by ablating mediastinal masses using freezing, laser, or other means.
Mediastinal diseases were diagnosed by lymph node biopsy combined with NGS, ROSE and other techniques using transairway ultrasound-guided mediastinal opening technique. Ablation of mediastinal malignancies is performed using techniques such as freezing or laser. Transbronchial lung biopsy(TBLB) may also be performed when necessary. Researchers will compare the experimental group with mediastinal opening and the control group without mediastinal opening to see if Mediastinal open technique benefits patients.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiographic abnormalities of mediastinum
- •Can tolerate general anesthesia
- •Can tolerate bronchoscopy and has the condition to have mediastinal biopsy and treatment
排除标准
- •Imaging or other tests can make a definitive diagnosis
- •Cannot tolerate general anesthesia or tracheoscopic surgery
- •Patients cannot sign informed consent forms
研究组 & 干预措施
Mediastinal open group
Mediastinal opening technique was performed with intraairway ultrasound guidance before transbronchial needle biopsy (TBNB). In addition, all patients with active pulmonary sarcoidosis and patients with fibrosing mediastinitis in this group will undergo transbronchial lung biopsy (TBLB) as a standardized supplementary procedure. TBNB and TBLB samples underwent histopathological assessment, single-cell sequencing and other detection methods.
干预措施: Intraairway ultrasound-guided mediastinal opening technique (Procedure)
Mediastinal open group
Mediastinal opening technique was performed with intraairway ultrasound guidance before transbronchial needle biopsy (TBNB). In addition, all patients with active pulmonary sarcoidosis and patients with fibrosing mediastinitis in this group will undergo transbronchial lung biopsy (TBLB) as a standardized supplementary procedure. TBNB and TBLB samples underwent histopathological assessment, single-cell sequencing and other detection methods.
干预措施: Transbronchial Lung Biopsy (TBLB) (Procedure)
Non-mediastinal open group
Diagnosis are routinely performed without mediastinal opening technique before transbronchial needle biopsy (TBNB).In addition, all patients with active pulmonary sarcoidosis and patients with fibrosing mediastinitis in this group will undergo transbronchial lung biopsy (TBLB) as a standardized supplementary procedure.TBNB and TBLB samples underwent histopathological assessment, single-cell sequencing and other detection methods.
干预措施: Transbronchial Lung Biopsy (TBLB) (Procedure)
结局指标
主要结局
In the diagnosis of mediastinal diseases, the difference in diagnosis rate between the experimental group with open mediastinum and the control group with traditional methods was observed
时间窗: 11 months
The contribution of pathological results to the final diagnosis of the disease between the experimental group and the control group was observed.That is, the difference in diagnostic accuracy between the experimental group and the control group.
次要结局
- quality of life survey(11 months)
- Cost of disease treatment(11 months)
- number of hospitalizations(11 months)
- Overall Survival(11 months)
研究者
Dan Liu
Doctor of Medicine
Tianjin Medical University General Hospital