- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06128681
Diagnosis and Comprehensive Treatment of Mediastinal Interventional Technique
Application Value of Respiratory Mediastinal Intervention Technique in Diagnosis and Comprehensive Treatment of Diseases
The goal of this observational study is to learn abou Whether patients undergoing mediastinal disease diagnosis and combined treatment with intrapacial ultrasound-guided mediastinal opening techniques have greater clinical benefit.
The participants were physically ill. 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.
Researchers will compare the experimental group with mediastinal opening and the control group without mediastinal opening to see if Mediastinal open technique benefits patients.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
-
Tianjin, China, 300000
- Recruiting
- Tianjin Medical University General Hospital
-
Contact:
- Dan Liu
- Phone Number: liudan_nkdx@163.com
- Email: liudan_nkdx@163.com
-
Contact:
- Jing Feng
- Phone Number: jingfeng_zyy@126.com
- Email: jingfeng_zyy@126.com
-
Principal Investigator:
- Dan Liu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Mediastinal open group
Mediastinal opening technique was performed with intraairway ultrasound guidance
|
Mediastinal intervention for patients with mediastinal imaging abnormalities is performed under general anesthesia to obtain biopsy specimens for detection or elimination of mediastinal masses
|
Non-mediastinal open group
Diagnosis and treatment are routinely performed without any manipulation of the mediastinum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: 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.
|
11 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall Survival
Time Frame: 11 months
|
11 months
|
quality of life survey
Time Frame: 11 months
|
11 months
|
number of hospitalizations
Time Frame: 11 months
|
11 months
|
Cost of disease treatment
Time Frame: 11 months
|
11 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Tianjinzyyhxkld
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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