The Comparison of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration, Mediastinal Cryobiopsy Via a Tunnel, and Forceps Biopsy Via a Tunnel in Diagnosing Mediastinal Lymphadenopathy: a Multicenter Randomised Controlled Trial.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this prospective, multi-centre, randomised controlled clinical study is to compare the diagnostic yield and safety of the three biopsy techniques (EBUS-TBNA, EBUS-TBMC via a tunnel, and EBUS-TBFB via a tunnel) in mediastinal/hilar lymph node biopsies. Participants will divided into EBUS-TBNA group, EBUS-TBMC via a tunnel group, and EBUS-TBFB via a tunnel group at a 1:1:1 ratio by using central, computerized random sequence, and then undertake EBUS-TBNA, EBUS-TBMC via a tunnel, or EBUS-TBFB according to the group. Researchers will compare the diagnostic yield and incidence of adverse events of the three biopsy techniques.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years;

• At least 1 hilar/mediastinal lesion (short axis ≥ 1 cm) requiring diagnostic bronchoscopy procedure;

• Patients who can understand the purpose of the trial, participate voluntarily and sign an informed consent form.

Locations
Other Locations
China
China-Japan Friendship Hospital
RECRUITING
Beijing
Contact Information
Primary
Gang Hou, MD
hougangcmu@163.com
010-84205729
Backup
Mingming Deng, PhD
isdeng@163.com
+86 18801336854
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2026-02-18
Participants
Target number of participants: 552
Treatments
Experimental: EBUS-transbronchial needle aspiration
Participants would undertake EBUS-transbronchial needle aspiration.
Experimental: EBUS-transbronchial mediastinal cryobiopsy via a tunnel
Participants would undertake EBUS-transbronchial mediastinal cryobiopsy via a tunnel.
Experimental: EBUS-transbronchial forceps biopsy via a tunnel
Participants would undertake EBUS-transbronchial forceps biopsy via a tunnel.
Related Therapeutic Areas
Sponsors
Leads: China-Japan Friendship Hospital

This content was sourced from clinicaltrials.gov