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Combined Application of EBUS and EUS in Lung Cancer

N

National Cancer Center (NCC)

Status

Completed

Conditions

Non Small Cell Lung Cancer

Treatments

Procedure: EUS-B-FNA followed by EBUS-TBNA
Procedure: EBUS-TBNA followed by EUS-B-FNA

Study type

Interventional

Funder types

Other

Identifiers

NCT01385111
NCC-EUSEBUS

Details and patient eligibility

About

This study aims to investigate a diagnostic yield and performance characteristics according to the order of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound-with bronchoscope-guided transbronchial needle aspiration (EUS-B-FNA) in the mediastinal staging of potentially operable lung cancer. EUS-FNA is a better tolerated procedure than EBUS-TBNA. Therefore, EUS-B-FNA can be the main procedure in a combined approach with EBUS-TBNA and EUS-B-FNA. In group A, the investigators perform EBUS-TBNA first and EUS-B-FNA is performed when necessary. In group B, EUS-B-FNA is first applied and EBUS-TBNA is performed when necessary. The hypothesis is that the diagnostic yield of the EUS centered procedure is as good as that of the EBUS centered procedure and the EUS centered procedure is more tolerable than the EBUS centered procedure. We evaluate diagnostic yields and performance characteristics of each group.

Enrollment

162 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histologically confirmed or strongly suspected non-small cell lung cancer (NSCLC)
  • Potentially operable patients

Exclusion criteria

  • M1 disease
  • Inoperable T4 disease
  • Mediastinal infiltration or extranodal invasion of the mediastinal lymph node visible on chest CT.
  • Confirmed supraclavicular lymph node metastasis
  • Pancoast tumors
  • Medically inoperable patients
  • Contraindications for bronchoscopy and esophageal endoscopy
  • Drug reaction to lidocaine, midazolam,fentanyl
  • Pregnancy
  • Ground glass-dominant nodule ( < 3cm)

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

162 participants in 2 patient groups

Arm A
Active Comparator group
Description:
EBUS centered
Treatment:
Procedure: EUS-B-FNA followed by EBUS-TBNA
Arm B
Experimental group
Description:
EUS centered
Treatment:
Procedure: EBUS-TBNA followed by EUS-B-FNA

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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