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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03793387
• Other study ID #: 107-097-F
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2020
• Source: National Taiwan University Hospital Hsin-Chu Branch
• Contact: Shun-Mao Yang, MD
• Phone: +886-972-654-475
• Email: mutayang[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Procedure:
• AF-guided endobronchial marking
Bronchoscopic dye marking under CBCT-augmented fluoroscopic guidance

Device:
• ENB-guided endobronchial marking
Bronchoscopic dye marking with ENB system

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital, Hsin-Chu Branch	Taipei	Hsin-Chu County

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital Hsin-Chu Branch

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful localization	Discrepancy from lesion to marking: less than 1 cm	2 days
Primary	Successful resection	Lesion contained in first resected specimen	2 days
Secondary	Localization duration	Total time span of localization procedure	1 day
Secondary	Total radiation exposure	Radiation during entire localization procedure	2 days
Secondary	Complication	Procedure related complication	14 days