NCT03793387

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

Preoperative Versus Intraoperative Transbronchial Dye Localization for Small Pulmonary Nodule : A Prospective Randomized Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National Taiwan University Hospital Hsin-Chu Branch · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	AF-guided endobronchial marking	Bronchoscopic dye marking under CBCT-augmented fluoroscopic guidance
DEVICE	ENB-guided endobronchial marking	Bronchoscopic dye marking with ENB system

Timeline

• Start date: 2019-07-08
• Primary completion: 2022-12-31
• Completion: 2023-06-30
• First posted: 2019-01-04
• Last updated: 2020-02-28

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated device study