Diagnosis and Comprehensive Treatment of Mediastinal Interventional Technique

Sponsor
Dan Liu (Other)
Overall Status
Recruiting
CT.gov ID
NCT06128681
Collaborator
(none)
30
1
13.7
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Intraairway ultrasound-guided mediastinal opening technique

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Application Value of Respiratory Mediastinal Intervention Technique in Diagnosis and Comprehensive Treatment of Diseases
Anticipated Study Start Date :
Nov 10, 2023
Anticipated Primary Completion Date :
Nov 30, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Mediastinal open group

Mediastinal opening technique was performed with intraairway ultrasound guidance

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

Non-mediastinal open group

Diagnosis and treatment are routinely performed without any manipulation of the mediastinum

Outcome Measures

Primary Outcome Measures

  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 [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 Outcome Measures

  1. Overall Survival [11 months]

  2. quality of life survey [11 months]

  3. number of hospitalizations [11 months]

  4. Cost of disease treatment [11 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tianjin Medical University General Hospital Tianjin China 300000

Sponsors and Collaborators

  • Dan Liu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dan Liu, Doctor of Medicine, Tianjin Medical University General Hospital
ClinicalTrials.gov Identifier:
NCT06128681
Other Study ID Numbers:
  • Tianjinzyyhxkld
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 13, 2023