Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-06 @ 12:24 PM
Study NCT ID:
NCT07352267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-20
First Post:
2026-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Value and Safety of Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy Versus Transbronchial Needle Aspiration in the Diagnosis of Lymphoma: a Randomized Controlled Trial
Sponsor:
China-Japan Friendship Hospital
Organization:
Study Overview
Official Title:
Diagnostic Value and Safety of Endobronchial Ultrasound-guided Transbronchial Mediastinal Cryobiopsy Versus Transbronchial Needle Aspiration in the Diagnosis of Lymphoma: a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn which of two minimally invasive procedures is better at safely diagnosing lymphoma in the mediastinum (chest) in adults (aged 18 and older) who are suspected to have either a new or a returning (relapsed) lymphoma. The main questions it aims to answer are:
Which procedure, endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMC) or endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), has a higher success rate in obtaining a definitive diagnosis? Is one procedure safer than the other in terms of complications? Researchers will compare the EBUS-TBMC group to the EBUS-TBNA group to see if the cryobiopsy technique leads to better diagnostic results and has a similar or better safety profile.
Participants will:
Be randomly assigned to undergo one of the two diagnostic procedures (EBUS-TBMC or EBUS-TBNA) during a single bronchoscopy session.
Have their tissue samples analyzed by pathologists. Be followed clinically for at least 6 months to confirm the final diagnosis.
Which procedure, endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy (EBUS-TBMC) or endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), has a higher success rate in obtaining a definitive diagnosis? Is one procedure safer than the other in terms of complications? Researchers will compare the EBUS-TBMC group to the EBUS-TBNA group to see if the cryobiopsy technique leads to better diagnostic results and has a similar or better safety profile.
Participants will:
Be randomly assigned to undergo one of the two diagnostic procedures (EBUS-TBMC or EBUS-TBNA) during a single bronchoscopy session.
Have their tissue samples analyzed by pathologists. Be followed clinically for at least 6 months to confirm the final diagnosis.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: