Diagnosis and Comprehensive Treatment of Mediastinal Interventional Technique

NCT06128681 | Recruiting

• 1 other identifier: Tianjinzyyhxkld
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mediastinal Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall Survival

  11 months

• quality of life survey

  11 months

• number of hospitalizations

  11 months

• Cost of disease treatment

  11 months

Other Outcomes (1)

• Immune cell profiling via single-cell RNA sequencing

  At the time of biopsy and sample collection

Study Arms (2)

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; Procedure: Transbronchial Lung Biopsy (TBLB)

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)

Interventions

Intraairway ultrasound-guided mediastinal opening technique PROCEDURE

Mediastinal intervention for patients with mediastinal imaging abnormalities is performed under general anesthesia to obtain biopsy specimens for detection or elimination of mediastinal masses

Mediastinal open group

Transbronchial Lung Biopsy (TBLB) PROCEDURE

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.

Mediastinal open group; Non-mediastinal open group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Radiographic abnormalities of mediastinum
• Can tolerate general anesthesia
• Can tolerate bronchoscopy and has the condition to have mediastinal biopsy and treatment

You may not qualify if:

• Imaging or other tests can make a definitive diagnosis
• Cannot tolerate general anesthesia or tracheoscopic surgery
• Patients cannot sign informed consent forms

Sponsors & Collaborators

• Dan Liu: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, 300000, China

RECRUITING

MeSH Terms

Conditions

Mediastinal Diseases

Condition Hierarchy (Ancestors)

Thoracic Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor of Medicine

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 13, 2023
• Study Start: December 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

CN (1)