Video-assisted Thoracic SurgeryNCT04690790
Pulmonary Nodule Localization Prospective Validation
An observational study of Video-assisted Thoracic Surgery and Pulmonary Nodules, run by E-DA Hospital at 1 site in Taiwan.
Trial summary
Localization is the key for successful excision of small target nodules under thoracoscopy, but the procedure also brings risks to patients. However, the criteria is still unclear. The investigators will validate the prediction model produced by institutional retrospective analysis in the prospective cohort. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Video-assisted Thoracic Surgery, Pulmonary Nodules
- What is being tested?
- Thoracoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Jan 2021to 31 Dec 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients indicated for thoracoscopic nodulectomy
Who may be able to join
- Age ≧ 20 years
- Lung nodule size ≦2cm on the pre-operative computed tomography (CT)
- Nodulectomy is performed under thoracoscopy
Who cannot join
- Age < 20 years
- Lung nodule size > 2cm on CT or in the final pathology report
- Open surgery for nodulectomy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
E-DA Hospital
Kaohsiung City, 824
Yuan-Kun Tu, +886-7-6150011, ed103390@edah.org.tw
Ming-Wei Kao
About this study
Official title: Pulmonary Nodule Localization Under Thoracoscopic Surgery- a Machine Learning Based Retrospective Analysis and Prospective Validation
Localization is the key for successful excision of small target nodules under thoracoscopy, but the procedure also brings risks to patients. However, the criteria is still unclear. The investigators will validate the prediction model produced by institutional retrospective analysis in the prospective cohort.
Read the detailed description
Excision of targeted lung nodules during thoracoscopy sometimes needs placing a mark before surgery. The procedure of mark placement (localization) could probably cause damages to the patients. However, the criteria for patient selection is still not clear. Through respective analysis, the investigators have set up a prediction model and wish to validate this model prospectively.
- Conditions
- Video-assisted Thoracic Surgery, Pulmonary Nodules
- Being tested
- Thoracoscopy
- Keywords
- Video-assisted thoracic surgery, Thoracoscopy, Localization, Pulmonary nodules
- Medical subject headings
- Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThoracoscopyProcedure or surgery
Patients who are indicated for thoracoscopic nodulectomy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Nodule detection
Whether the nodule could be detected by conventional visualization or palpation
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start23 Jan 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Video-assisted Thoracic SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- E-DA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tu, Yuan-Kun, E-DA Hospital
- Investigators
- Ming-Wei Kao, M.D., M.S., Principal investigator, E-DA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690790
- Sponsor's protocol ID
- EMRP56109N
- Status last verified
- Jan 2021
- First submitted
- 28 Dec 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Nodule Localization Under Thoracoscopic Surgery- a Machine Learning Based Retrospective Analysis and Prospective Validation
- ClinicalTrials.gov ID
- NCT04690790
- Acronym / sponsor ID
- EMRP56109N
- Conditions
- Video-assisted Thoracic Surgery, Pulmonary Nodules
- Keywords
- Video-assisted thoracic surgery, Thoracoscopy, Localization, Pulmonary nodules
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- E-DA HospitalUniversity, hospital or other
- Study start
- 23 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 31 Dec 2020 (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.
Localization is the key for successful excision of small target nodules under thoracoscopy, but the procedure also brings risks to patients. However, the criteria is still unclear. The investigators will validate the prediction model produced by institutional retrospective analysis in the prospective cohort.
Detailed description
Excision of targeted lung nodules during thoracoscopy sometimes needs placing a mark before surgery. The procedure of mark placement (localization) could probably cause damages to the patients. However, the criteria for patient selection is still not clear. Through respective analysis, the investigators have set up a prediction model and wish to validate this model prospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients indicated for thoracoscopic nodulectomy
Key inclusion criteria (3 listed)
- Age ≧ 20 years
- Lung nodule size ≦2cm on the pre-operative computed tomography (CT)
- Nodulectomy is performed under thoracoscopy
Key exclusion criteria (3 listed)
- Age < 20 years
- Lung nodule size > 2cm on CT or in the final pathology report
- Open surgery for nodulectomy
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 |
|---|---|---|
| ThoracoscopyPatients who are indicated for thoracoscopic nodulectomy. | Procedure or surgery | – |
Primary outcome
Nodule detection
Time frame: During surgery
Whether the nodule could be detected by conventional visualization or palpation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
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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.
Ming-Wei Kao, M.D., M.S. principal investigator
E-DA Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Video-assisted Thoracic Surgery and Pulmonary Nodules, run by E-DA Hospital 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 3 inclusion and 3 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 26 Jan 2021. 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 Ming-Wei Kao, M.D., M.S. (+886-7-6150011 ext. 252523, ed107576@edah.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nodule detection (time frame: During surgery). 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 26 Jan 2021.