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

Sponsor

National Taiwan University Hospital Hsin-Chu Branch (Other)

Overall Status

Recruiting

CT.gov ID

NCT03793387

Collaborator

(none)

Enrollment

Location

Arms

47.7

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Procedure: AF-guided endobronchial marking Device: ENB-guided endobronchial marking	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 8, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pre-op	Procedure: AF-guided endobronchial marking Bronchoscopic dye marking under CBCT-augmented fluoroscopic guidance
Active Comparator: Intra-op	Device: ENB-guided endobronchial marking Bronchoscopic dye marking with ENB system

Arm

Intervention/Treatment

Experimental: Pre-op

Procedure: AF-guided endobronchial marking

Bronchoscopic dye marking under CBCT-augmented fluoroscopic guidance

Active Comparator: Intra-op

Device: ENB-guided endobronchial marking

Bronchoscopic dye marking with ENB system

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital, Hsin-Chu Branch	Taipei	Hsin-Chu County	Taiwan	30059

Sponsors and Collaborators

National Taiwan University Hospital Hsin-Chu Branch

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital Hsin-Chu Branch

ClinicalTrials.gov Identifier:

NCT03793387

Other Study ID Numbers:

107-097-F

First Posted:

Jan 4, 2019

Last Update Posted:

Feb 28, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Study Results

No Results Posted as of Feb 28, 2020