Lung CancerNCT03793387
Intra-op vs Pre-op Transbronchial Localization for Small Lung Nodule
A study testing AF-guided endobronchial marking and ENB-guided endobronchial marking in people with Lung Cancer, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
Trial summary
Comparing pre-operative transbronchial localization under augmented fluoroscopy and intra-operative transbronchial localization using electromagnetic navigation bronchoscopy system for small lung nodules. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- AF-guided endobronchial marking and ENB-guided endobronchial marking
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Jul 2019to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital, Hsin-Chu Branch
Taipei, Hsin-Chu County, 30059
Chiu-kuei Nien, 886-3-5326151, hch01215@hch.gov.tw
About this study
Official title: 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.
Read the 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
- Being tested
- AF-guided endobronchial marking, ENB-guided endobronchial marking
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AF-guided endobronchial markingProcedure or surgery
Bronchoscopic dye marking under CBCT-augmented fluoroscopic guidance
ENB-guided endobronchial markingDevice
Bronchoscopic dye marking with ENB system
| Study group | Role | What they receive |
|---|---|---|
| Pre-op | Experimental | Not described Receives: Procedure: AF-guided endobronchial marking |
| Intra-op | Active comparator | Not described Receives: Device: ENB-guided endobronchial marking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful localization
Discrepancy from lesion to marking: less than 1 cm
Measured: 2 days
Successful resection
Lesion contained in first resected specimen
Measured: 2 days
Secondary outcomes (3)
Localization duration
Total time span of localization procedure
Measured: 1 day
Total radiation exposure
Radiation during entire localization procedure
Measured: 2 days
Complication
Procedure related complication
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start8 Jul 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03793387
- Sponsor's protocol ID
- 107-097-F
- Status last verified
- Feb 2020
- First submitted
- 2 Jan 2019
- Last updated
- 28 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Versus Intraoperative Transbronchial Dye Localization for Small Pulmonary Nodule : A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03793387
- Acronym / sponsor ID
- 107-097-F
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 4 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-op | Experimental | Procedure: AF-guided endobronchial marking |
| Intra-op | Active comparator | Device: ENB-guided endobronchial marking |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AF-guided endobronchial markingBronchoscopic dye marking under CBCT-augmented fluoroscopic guidance | Procedure or surgery | Pre-op |
| ENB-guided endobronchial markingBronchoscopic dye marking with ENB system | Device | Intra-op |
Primary outcome
Successful localization
Time frame: 2 days
Discrepancy from lesion to marking: less than 1 cm
Successful resection
Time frame: 2 days
Lesion contained in first resected specimen
3 secondary outcomes
Localization duration
Time frame: 1 day
Total radiation exposure
Time frame: 2 days
Complication
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AF-guided endobronchial marking and ENB-guided endobronchial marking in people with Lung Cancer, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shun-Mao Yang, MD (+886-972-654-475, mutayang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful localization (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2020.