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Intra-op vs Pre-op Transbronchial Localization for Small Lung Nodule

N

National Taiwan University Hospital Hsin-Chu Branch

Status

Unknown

Conditions

Lung Cancer

Treatments

Procedure: AF-guided endobronchial marking
Device: ENB-guided endobronchial marking

Study type

Interventional

Funder types

Other

Identifiers

NCT03793387
107-097-F

Details and patient eligibility

About

Comparing pre-operative transbronchial localization under augmented fluoroscopy and intra-operative transbronchial localization using electromagnetic navigation bronchoscopy system for small lung nodules.

Full description

Using electromagnetic navigation bronchoscopy (ENB), transbronchial localization can be performed in the operating room (OR) under general anesthesia without extra radiation exposure, which is expected to reduce the discomfort for the patient during localization. This study will be carried out at the Hsinchu Branch of National Taiwan University Hospital. It is expected that 40 patients with pulmonary nodules will be randomly assigned into two groups. One group will receive bronchoscopic dye localization in the hybrid examination room equipped with cone-beam computed tomography, and the other group will receive ENB-guided dye localization in OR. The primary goal of the study was to compare the localization duration of the two groups of patients, the total dose of radiation exposure during localization and the incidence of location-related complications, and the secondary goals were the results of the surgical procedure, including the surgical duration.

Enrollment

40 estimated patients

Sex

All

Ages

20 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A. One of each: lung nodule size less than 1 cm; depth more than 2 cm; GGO lesion B. 20~90 years old C. sign permit

Exclusion criteria

A. Previous emphysema, TB, COPD B. Previous ipsilateral thoracic surgery C. Bleeding tendency D. Heart failure, cirrhosis, CKD E. Pregnancy or breast feeding F. Immunocompromised G. Severe infection H. Unable to sign permit

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Pre-op
Experimental group
Treatment:
Procedure: AF-guided endobronchial marking
Intra-op
Active Comparator group
Treatment:
Device: ENB-guided endobronchial marking

Trial contacts and locations

1

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Central trial contact

Shun-Mao Yang, MD

Data sourced from clinicaltrials.gov

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