Diagnosis and Comprehensive Treatment of Mediastinal Interventional Technique
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraairway ultrasound-guided mediastinal opening technique, Transbronchial Lung Biopsy (TBLB).
- Who it may be relevant to
- Registry conditions: Mediastinal Diseases. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Application Value of Respiratory Mediastinal Intervention Technique in Diagnosis and Comprehensive Treatment of Diseases
Overview
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.
Interventions
- Procedure Intraairway ultrasound-guided mediastinal opening technique
Mediastinal intervention for patients with mediastinal imaging abnormalities is performed under general anesthesia to obtain biopsy specimens for detection or elimination of mediastinal masses - Procedure Transbronchial Lung Biopsy (TBLB)
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.
Primary outcome measures
- 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 [Time frame: 11 months]
Secondary outcome measures (4)
- Overall Survival [Time frame: 11 months]
- quality of life survey [Time frame: 11 months]
- number of hospitalizations [Time frame: 11 months]
- Cost of disease treatment [Time frame: 11 months]
Eligibility criteria
Inclusion criteria
- Radiographic abnormalities of mediastinum
- Can tolerate general anesthesia
- Can tolerate bronchoscopy and has the condition to have mediastinal biopsy and treatment
Exclusion criteria
- Imaging or other tests can make a definitive diagnosis
- Cannot tolerate general anesthesia or tracheoscopic surgery
- Patients cannot sign informed consent forms
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Tianjin Medical University General Hospital — Tianjin
Identifiers
NCT: NCT06128681 · Tianjinzyyhxkld