Lung CancerUNeedNCT03439696
Needlescopic-assisted Uniportal vs Uniportal VATS
A study testing Thoracoscopic surgery in people with Lung Cancer and Lung Cancer Metastatic, run by IRB of NTUH Hsin-Chu Branch at 1 site in Taiwan.
Trial summary
The investigators' study aims is to evaluate the safety and efficacy of uniportal VATS under assistance of needlescopic instruments through additional 2-3 mm ports compared to conventional uniportal VATS in patients with lung lesions. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Lung Cancer, Lung Cancer Metastatic, Bullous Disease Lung
- What is being tested?
- Thoracoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Feb 2018to 30 Apr 2019
- 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
- Lung or mediastinal disease requiring thoracoscopic surgery
Who cannot join
- Thoracoscopic esophagectomy Decortication for empyema
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital, Hsin-Chu Branch
Taipei, Hsin-Chu County, 30059
About this study
Official title: Needlescopic-assisted Uniportal VATS Versus Conventional Uniportal VATS. A Randomized Prospective Noninferiority Study
The investigators' study aims is to evaluate the safety and efficacy of uniportal VATS under assistance of needlescopic instruments through additional 2-3 mm ports compared to conventional uniportal VATS in patients with lung lesions.
- Conditions
- Lung Cancer, Lung Cancer Metastatic, Bullous Disease Lung, Nodule Solitary Pulmonary, Mediastinal Tumor
- Being tested
- Thoracoscopic surgery
- Keywords
- Thoracoscopy, VATS, Needlescopy, Uniportal
- Medical subject headings
- Lung Neoplasms, Solitary Pulmonary Nodule, Mediastinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracoscopic surgeryProcedure or surgery
Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.
| Study group | Role | What they receive |
|---|---|---|
| Needlescopic-assisted | Experimental | Thoracoscopic surgery performed with the fashion of single 2.5-3.5 cm intercostal incision and 1-2 additional 2-3 mmm needlescopic ports. Receives: Procedure: Thoracoscopic surgery |
| Uniportal | Active comparator | Conventional uniportal VATS with single 2.5-3.5 cm intercostal incision Receives: Procedure: Thoracoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scale POD 3
Post-operative day 3 pain scale documented using Visual Analogue Scale (VAS)
Measured: 3 days
Pain scale POD 5
Post-operative day 5 pain scale documented using Visual Analogue Scale (VAS)
Measured: 5 days
Hospital stay
Post-operative hospital stay
Measured: 14 days
Post-operative 3 month neuralgia
Out patient documented using PainDETECT questionnaire (PD-Q)
Measured: 3 months
Post-operative 6 month neuralgia
Out patient documented using PainDETECT questionnaire (PD-Q)
Measured: 6 months
Secondary outcomes (4)
Cost
Total hospital cost
Measured: 14 days
Surgical time
Time spend in surgery
Measured: 1 day
Surgical bleeding
Blood loss during operation
Measured: 1 day
Opioid using dosage
Total opioid equivalent dose used during post-operative course
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 posted20 Feb 2018
- Study start22 Feb 2018
- Primary completion12 Dec 2018
- Study completion30 Apr 2019
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRB of NTUH Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, IRB of NTUH Hsin-Chu Branch, National Taiwan University Hospital Hsin-Chu Branch
- Investigators
- Chiu-kuei Nien, Principal investigator, National Taiwan University Hospital Hsinchu Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439696
- Sponsor's protocol ID
- 106-067-F
- Acronym
- UNeed
- Status last verified
- Feb 2021
- First submitted
- 7 Feb 2018
- Last updated
- 25 Feb 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 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needlescopic-assisted Uniportal VATS Versus Conventional Uniportal VATS. A Randomized Prospective Noninferiority Study
- ClinicalTrials.gov ID
- NCT03439696
- Acronym / sponsor ID
- UNeed / 106-067-F
- Conditions
- Lung Cancer, Lung Cancer Metastatic, Bullous Disease Lung, Nodule Solitary Pulmonary, Mediastinal Tumor
- Keywords
- Thoracoscopy, VATS, Needlescopy, Uniportal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- IRB of NTUH Hsin-Chu BranchUniversity, hospital or other
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 20 Feb 2018 (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.
The investigators' study aims is to evaluate the safety and efficacy of uniportal VATS under assistance of needlescopic instruments through additional 2-3 mm ports compared to conventional uniportal VATS in patients with lung lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Needlescopic-assisted | Experimental | Procedure: Thoracoscopic surgeryThoracoscopic surgery performed with the fashion of single 2.5-3.5 cm intercostal incision and 1-2 additional 2-3 mmm needlescopic ports. |
| Uniportal | Active comparator | Procedure: Thoracoscopic surgeryConventional uniportal VATS with single 2.5-3.5 cm intercostal incision |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Lung or mediastinal disease requiring thoracoscopic surgery
Key exclusion criteria (1 listed)
- Thoracoscopic esophagectomy Decortication for empyema
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 |
|---|---|---|
| Thoracoscopic surgeryVideo-assisted thoracoscopic surgery for pulmonary or mediastinal lesions. | Procedure or surgery | Needlescopic-assisted, Uniportal |
Primary outcome
Pain scale POD 3
Time frame: 3 days
Post-operative day 3 pain scale documented using Visual Analogue Scale (VAS)
Pain scale POD 5
Time frame: 5 days
Post-operative day 5 pain scale documented using Visual Analogue Scale (VAS)
Hospital stay
Time frame: 14 days
Post-operative hospital stay
Post-operative 3 month neuralgia
Time frame: 3 months
Out patient documented using PainDETECT questionnaire (PD-Q)
Post-operative 6 month neuralgia
Time frame: 6 months
Out patient documented using PainDETECT questionnaire (PD-Q)
4 secondary outcomes
Cost
Time frame: 14 days
Surgical time
Time frame: 1 day
Surgical bleeding
Time frame: 1 day
Opioid using dosage
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 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.
Chiu-kuei Nien principal investigator
National Taiwan University Hospital Hsinchu Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracoscopic surgery in people with Lung Cancer and Lung Cancer Metastatic, run by IRB of NTUH 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: finished, as of the sponsor's last update on 25 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scale POD 3 (time frame: 3 days). The study lists 5 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 25 Feb 2021.