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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraairway ultrasound-guided mediastinal opening technique | Procedure | Mediastinal intervention for patients with mediastinal imaging abnormalities is performed under general anesthesia to obtain biopsy specimens for detection or elimination of mediastinal masses |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 11 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 11 months | |
| quality of life survey | 11 months | |
| number of hospitalizations |
| Measure | Description | Time Frame |
|---|---|---|
| Immune cell profiling via single-cell RNA sequencing | Single-cell RNA sequencing will be performed on blood, bronchoalveolar lavage fluid (BALF), transbronchial needle biopsy (TBNB) and transbronchial lung biopsy (TBLB) tissue samples to characterize immune cell profiles, identify pathogenic mechanisms, and discover potential therapeutic targets in patients with active pulmonary sarcoidosis. | At the time of biopsy and sample collection |
Inclusion Criteria:
Exclusion Criteria:
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The patient had mediastinal imaging abnormalities, and the disease type could not be identified through routine examination, and it was difficult to carry out further treatment or the patient was not satisfied with the previous treatment effect; In addition, patients with clearly diagnosed malignant tumors are difficult to perform tumor resection, or patients with other reasons are difficult to tolerate surgical open surgery, and mediastinal tumor ablation can reduce tumor compression and achieve the purpose of tumor reduction
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University General Hospital | Recruiting | Tianjin | 300000 | China |
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| ID | Term |
|---|---|
| D008477 | Mediastinal Diseases |
| ID | Term |
|---|---|
| D013896 | Thoracic Diseases |
| D012140 | Respiratory Tract Diseases |
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| Transbronchial Lung Biopsy (TBLB) | Procedure | A standardized supplementary procedure performed in all patients with active pulmonary sarcoidosis and fibrosing mediastinitis, regardless of their primary study group assignment, to obtain lung tissue for histopathological diagnosis and disease activity assessment. |
|
| 11 months |
| Cost of disease treatment | 11 months |