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NCT Number: NCT06128681

Diagnosis and Comprehensive Treatment of Mediastinal Interventional Technique

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

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

    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.

Secondary outcomes

  1. Overall Survival

    Time frame: 11 months

  2. quality of life survey

    Time frame: 11 months

  3. number of hospitalizations

    Time frame: 11 months

  4. Cost of disease treatment

    Time frame: 11 months

Other outcomes

  1. Immune cell profiling via single-cell RNA sequencing

    Time frame: At the time of biopsy and sample collection

    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.

Sponsors and collaborators

Lead sponsor

Dan Liu

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2023
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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