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 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.

Study Overview

• Status: Recruiting
• Conditions: Mediastinal Diseases
• Intervention / Treatment: Procedure: Intraairway ultrasound-guided mediastinal opening technique; Procedure: Transbronchial Lung Biopsy (TBLB)

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• China
  • 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: No

• Sampling Method: Non-Probability Sample

Study Population

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

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?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.	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.

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	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	11 months
quality of life survey	11 months
number of hospitalizations	11 months
Cost of disease treatment	11 months

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Dan Liu

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 7, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Thoracic Diseases; Mediastinal Diseases
• Other Study ID Numbers: Tianjinzyyhxkld

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No