Diagnosis and Comprehensive Treatment of Mediastinal Interventional Technique

Recruiting

• Conditions: Mediastinal Diseases
• Interventions: Procedure: Intraairway ultrasound-guided mediastinal opening technique

• Registration Number: NCT06128681
• Lead Sponsor: Dan Liu

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2023-11-03
• Study First Submitted QC: 2023-11-10
• Study First Posted: 2023-11-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-31
• Last Update Posted: 2025-01-01
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mediastinal open group	Intraairway ultrasound-guided mediastinal opening technique	Mediastinal opening technique was performed with intraairway ultrasound guidance

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

Name	Time	Method
quality of life survey	11 months
Cost of disease treatment	11 months
number of hospitalizations	11 months
Overall Survival	11 months

Trial Locations

Locations (1)

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, China