Diagnosis and Comprehensive Treatment of Mediastinal Interventional Technique

Mediastinal Diseases Clinical Trial

Official title:

Application Value of Respiratory Mediastinal Intervention Technique in Diagnosis and Comprehensive Treatment of Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06128681
• Other study ID #: Tianjinzyyhxkld
• Status: Recruiting
• Start date: November 10, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Tianjin Medical University General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Mediastinal Diseases

Intervention

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

Locations

Country	Name	City	State
China	Tianjin Medical University General Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Dan Liu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Overall Survival		11 months
Secondary	quality of life survey		11 months
Secondary	number of hospitalizations		11 months
Secondary	Cost of disease treatment		11 months