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

Not Applicable

• Conditions: Lung Cancer
• Interventions: Device: ENB-guided endobronchial marking; Procedure: AF-guided endobronchial marking

• Registration Number: NCT03793387
• Lead Sponsor: National Taiwan University Hospital Hsin-Chu Branch

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-01-02
• Study First Submitted QC: 2019-01-02
• Study First Posted: 2019-01-04
• Study Start: 2019-07-08
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-28
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-op	ENB-guided endobronchial marking	-
Pre-op	AF-guided endobronchial marking	-

Primary Outcome Measures

Name	Time	Method
Successful localization	2 days	Discrepancy from lesion to marking: less than 1 cm
Successful resection	2 days	Lesion contained in first resected specimen

Secondary Outcome Measures

Name	Time	Method
Localization duration	1 day	Total time span of localization procedure
Total radiation exposure	2 days	Radiation during entire localization procedure
Complication	14 days	Procedure related complication

Trial Locations

Locations (1)

National Taiwan University Hospital, Hsin-Chu Branch; 🇨🇳 Taipei, Hsin-Chu County, Taiwan