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Diagnosis and Comprehensive Treatment of Mediastinal Interventional Technique

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06128681
Enrollment
30
Registered
2023-11-13
Start date
2021-12-01
Completion date
2026-12-31
Last updated
2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mediastinal Diseases

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.

Interventions

PROCEDUREIntraairway 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

PROCEDURETransbronchial 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.

Sponsors

Dan Liu
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 observed11 monthsThe 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

MeasureTime frame
Overall Survival11 months
quality of life survey11 months
number of hospitalizations11 months
Cost of disease treatment11 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026