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The Comparison of EBUS-TBNA, TBMC Via a Tunnel, and TBFB Via a Tunnel in Diagnosing Mediastinal Lymphadenopathy.

StatusUnknown
PhaseNot applicable
Started2024-03-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 27, 2024 (before its estimated February 18, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-09-06
Trial status changed: Recruiting → Unknown
2024-08-24
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions v3
Trial statusRecruiting→Unknown
Enrollment target723→552
InterventionsEBUS-TBFB (Procedure), EBUS-TBMC via a tunnel (Procedure), EBUS-TBNA (Procedure)→EBUS-TBFB via a tunnel (Procedure), EBUS-TBMC via a tunnel (Procedure), EBUS-TBNA (Procedure)
Study title+13 characters
The Comparison of EBUS-TBNA, TBMC Via a Tunnel, and TBFB Via a Tunnel in Diagnosing Mediastinal Lymphadenopathy.
2024-08-11
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures v2
InterventionsEBUS-TBNA (Procedure), EBUS-TTCB (Procedure), EBUS-TTFB (Procedure)→EBUS-TBFB (Procedure), EBUS-TBMC via a tunnel (Procedure), EBUS-TBNA (Procedure)
Primary endpoints3 entries, revised
Dignostic yield of EBUS-TBNA, EBUS-TTCBTBMC via a tunnel, and EBUS-TTFBTBFB
Study title+13 characters
The Comparison of EBUS-TBNA, TTCBTBMC Via a Tunnel, and TTFBTBFB in Diagnosing Mediastinal Lymphadenopathy.
2024-08-08
Not Yet Recruiting→Recruiting Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-02-18→confirmed 2024-03-01
Study sites0→1
InterventionsEBUS-TBCB (Procedure), EBUS-TBFB (Procedure), EBUS-TBNA (Procedure)→EBUS-TBNA (Procedure), EBUS-TTCB (Procedure), EBUS-TTFB (Procedure)
Eligibility criteriarevised
Inclusion Criteria: Age ≥ 1518 years; At least 1 hilar/mediastinal lesion (short axis ≥ 1 [...]
Secondary endpoints+34 characters
the adequacy of sample acquisition
Primary endpoints4 to 3 entries
Dignostic rateyield of EBUS-TBNA, EBUS-TBCBTTCB, and EBUS-TBFB the quality of sample acquisitionTTFB
Study title-7 characters
The ComparisonofComparison Mediastinal/Hilar Lymph Node Biopsies byof EBUS-TBNA, EBUS-TBCBTTCB, and EBUS-TBFBTTFB in Diagnosing Mediastinal Lymphadenopathy.
2024-02-08
Original filing
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.
Trial Details
NCT Number NCT06262620
Lead Sponsor China-Japan Friendship Hospital
Conditions Lymphadenopathy Hilar, Lymphadenopathy Mediastinal
Enrollment 552 participants
Start Date 2024-03-01
Primary Completion 2026-02-18 (estimated)
Study Completion 2026-02-18 (estimated)
Updated on ClinicalTrials.gov 2024-08-27