Study on Transbronchial Ultrasound-guided Cryobiopsy in the Diagnosis of Mediastinal Lymphadenopathy

Mediastinal Lymphadenopathy Clinical Trial

Official title:

The Effectiveness and Safety of Transbronchial Ultrasound-guided Cryobiopsy in the Diagnosis of Mediastinal Lymphadenopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05803239
• Other study ID #: 2022-NHLHCRF-LX-01-0201-03
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: China-Japan Friendship Hospital
• Contact: Mingming Deng, MD
• Phone: 86 18801336854
• Email: isdeng1017[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate the diagnostic effcacy and safety of transbronchial ultrasound-guided cryobiopsy in the diagnosis of mediastinal lymphadenopathy. The main question it aims to answer are: the effectiveness and safety of transbronchial ultrasound-guided cryobiopsy in the diagnosis of mediastinal lymphadenopathy.

Participants will undergo transbronchial ultrasound-guided cryobiopsy (EBUS-TBCB) and endobronchial ultrasound-guided trans-bronchial needle aspiration (EBUS-TBNA).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients withmediastinal lymphadenopathy of unknown cause, patients with suspected sarcoidosis or lymphoma, or patients who need to undergo EBUS-TBNA for the second time

• The selected patients should complete the routine examination of EBUS-TBNA/EBUS-TBCB before operation, such as blood routine examination, coagulation function, electrocardiogram, chest CT, etc

• There was no contraindication of puncture and cryobiopsy

• No age limit, no gender limit

• Good compliance, able to cooperate with research and observation

• Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form

Exclusion Criteria:

• The patient is allergic to lidocaine and midazolam

• The site to be biopsied has a high risk of bleeding such as bronchial artery penetration or suspected lung metastasis of renal cancer

• Unstable angina pectoris, congestive heart failure, severe bronchial asthma

• The patient did not agree to participate in this study

• Participation in other studies within three months without withdrawal or termination will affect the observation of this study

• The researcher believes that there is any person who is not suitable for the selection

Related Conditions & MeSH terms

• Lymphadenopathy
• Mediastinal Lymphadenopathy

Intervention

Device:
• EBUS-TBNA
Participants would undergo EBUS-TBNA(NA-201SX-4022, OLYMPUS MEDICAL SYSTEMS CORP, JAPAN).
• EBUS-TBCB
Participants would undergo EBUS-TBCB(20402-401, ERBE Elektromedizin Gmbh, Germany).

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	BeiJing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological diagnosis rate	The diagnosis would be confirmed according to the pathological results	7 days after the biopsy
Secondary	Incidence rate of adverse events	Symptoms and signs	7 days after the biopsy
Secondary	Size of specimen	measurement	during the procedure
Secondary	Specimen quality	questionnaire	during the procedure