Clinical trial NCT06128681: Diagnosis and Comprehensive Treatment of Mediastinal Interventional Technique
Official title: Application Value of Respiratory Mediastinal Intervention Technique in Diagnosis and Comprehensive Treatment of Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mediastinal Diseases
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 11 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 11 months
measure: quality of life survey
timeFrame: 11 months
measure: number of hospitalizations
timeFrame: 11 months
measure: Cost of disease treatment
timeFrame: 11 months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
Study officials:
References: