- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03793387
Intra-op vs Pre-op Transbronchial Localization for Small Lung Nodule
February 26, 2020 updated by: National Taiwan University Hospital Hsin-Chu Branch
Preoperative Versus Intraoperative Transbronchial Dye Localization for Small Pulmonary Nodule : A Prospective Randomized Trial
Comparing pre-operative transbronchial localization under augmented fluoroscopy and intra-operative transbronchial localization using electromagnetic navigation bronchoscopy system for small lung nodules.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shun-Mao Yang, MD
- Phone Number: +886-972-654-475
- Email: mutayang@gmail.com
Study Locations
-
-
Hsin-Chu County
-
Taipei, Hsin-Chu County, Taiwan, 30059
- Recruiting
- National Taiwan University Hospital, Hsin-Chu Branch
-
Contact:
- Chiu-kuei Nien
- Phone Number: 886-3-5326151
- Email: hch01215@hch.gov.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pre-op
|
Bronchoscopic dye marking under CBCT-augmented fluoroscopic guidance
|
Active Comparator: Intra-op
|
Bronchoscopic dye marking with ENB system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Successful localization
Time Frame: 2 days
|
Discrepancy from lesion to marking: less than 1 cm
|
2 days
|
Successful resection
Time Frame: 2 days
|
Lesion contained in first resected specimen
|
2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Localization duration
Time Frame: 1 day
|
Total time span of localization procedure
|
1 day
|
Total radiation exposure
Time Frame: 2 days
|
Radiation during entire localization procedure
|
2 days
|
Complication
Time Frame: 14 days
|
Procedure related complication
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 8, 2019
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
June 30, 2023
Study Registration Dates
First Submitted
January 2, 2019
First Submitted That Met QC Criteria
January 2, 2019
First Posted (Actual)
January 4, 2019
Study Record Updates
Last Update Posted (Actual)
February 28, 2020
Last Update Submitted That Met QC Criteria
February 26, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 107-097-F
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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