Single-port Video-assisted Thoracoscopic SurgeryNCT04212481
RCT of Uniport VATS for Lung Cancer
A study testing uniport video-assisted thoracoscopic surgery, two ports video-assisted thoracoscopic surgery and three ports video-assisted thoracoscopic surgery in people with Single-port Video-assisted Thoracoscopic Surgery, run by The Second Hospital of Shandong University at 1 site in China.
Trial summary
Video-assisted thoracoscopic surgery (VATS) has been widely used for non-small cell lung cancer (NSCLC) for nearly two decades. Usually, it was applied through three ports with at least one drainage after surgery, which often lead to acute chest pain. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Single-port Video-assisted Thoracoscopic Surgery
- What is being tested?
- uniport video-assisted thoracoscopic surgery, two ports video-assisted thoracoscopic surgery and three ports video-assisted thoracoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2019to 30 Dec 2025
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with cT1-3N0-1M0 NSCLC; good cardiopulmonary function; prepared to undergo radical resection;
Who cannot join
- patients with N3 or M1 NSCLC; poor cardiopulmonary function; not be prepared to undergo radical resection;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Shandong University
Jinan, Shandong, 250033
Yunpeng Zhao, doctor, +8618766188692
About this study
Official title: Randomized Controlled Trial of the Comparison of Uniport VATS and Non- Uniport VATS for Lung Cancer
Video-assisted thoracoscopic surgery (VATS) has been widely used for non-small cell lung cancer (NSCLC) for nearly two decades. Usually, it was applied through three ports with at least one drainage after surgery, which often lead to acute chest pain. Therefore, fewer, smaller ports, and wider intercostal space for surgery has been required.
Uniport VATS became a feasible option with the development of surgical techniques and instruments, with potentially less postoperative pain and shorter hospital stays. However, there may be some complications, or with a longer time of operation, even more difficult in lymph nodes resection during learning curve.
In our study, a Randomized Controlled Trial was designed to study the operation time, perioperative blood loss, conversion rate, duration of postoperative drainage, length of hospital stay, visual analogue score of postoperative pain, complications, and survival.
- Being tested
- uniport video-assisted thoracoscopic surgery, two ports video-assisted thoracoscopic surgery, three ports video-assisted thoracoscopic surgery
- Keywords
- Non Small Cell Lung Cancer, Perioperative Efficacy, multi-port
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uniport video-assisted thoracoscopic surgeryProcedure or surgery
video-assisted thoracoscopic surgery for NSCLC using single port or two ports or three ports
two ports video-assisted thoracoscopic surgeryProcedure or surgery
video-assisted thoracoscopic surgery for NSCLC using two ports
three ports video-assisted thoracoscopic surgeryProcedure or surgery
video-assisted thoracoscopic surgery for NSCLC using three ports
| Study group | Role | What they receive |
|---|---|---|
| single port group | Experimental | Uniport video-assisted thoracoscopic surgery for NSCLC Receives: Procedure: uniport video-assisted thoracoscopic surgery |
| two ports group | Active comparator | video-assisted thoracoscopic surgery for NSCLC using two ports Receives: Procedure: two ports video-assisted thoracoscopic surgery |
| three ports group | Active comparator | video-assisted thoracoscopic surgery for NSCLC using three ports Receives: Procedure: three ports video-assisted thoracoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
operative time in minutes
Measured: 1 day
perioperative blood loss
perioperative blood loss in milliliter
Measured: 1 day
conversion rate
conversion rate in proportion
Measured: 1 day
duration of postoperative drainage
duration of postoperative drainage in days
Measured: within 5-7 days
length of hospital stay
length of hospital stay in days
Measured: within 5-7 days
visual analogue score of postoperative pain
score
Measured: within 5-7 days
complications
complications in rate
Measured: up to 3 months
Secondary outcomes (2)
overall survival
overall survival in rate
Measured: up to 5 years
progression- free survival
progression- free survival in rate
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2019
- Study start25 Dec 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single-port Video-assisted Thoracoscopic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaogang Zhao, Doctor, Study director, The Second Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212481
- Sponsor's protocol ID
- Uniport VATS ZYP1
- Status last verified
- Nov 2022
- First submitted
- 21 Dec 2019
- Last updated
- 16 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of the Comparison of Uniport VATS and Non- Uniport VATS for Lung Cancer
- ClinicalTrials.gov ID
- NCT04212481
- Acronym / sponsor ID
- Uniport VATS ZYP1
- Keywords
- Non Small Cell Lung Cancer, Perioperative Efficacy, multi-port
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 25 Dec 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 27 Dec 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.
Video-assisted thoracoscopic surgery (VATS) has been widely used for non-small cell lung cancer (NSCLC) for nearly two decades. Usually, it was applied through three ports with at least one drainage after surgery, which often lead to acute chest pain. Therefore, fewer, smaller ports, and wider intercostal space for surgery has been required.
Uniport VATS became a feasible option with the development of surgical techniques and instruments, with potentially less postoperative pain and shorter hospital stays. However, there may be some complications, or with a longer time of operation, even more difficult in lymph nodes resection during learning curve.
In our study, a Randomized Controlled Trial was designed to study the operation time, perioperative blood loss, conversion rate, duration of postoperative drainage, length of hospital stay, visual analogue score of postoperative pain, complications, and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| single port group | Experimental | Procedure: uniport video-assisted thoracoscopic surgeryUniport video-assisted thoracoscopic surgery for NSCLC |
| two ports group | Active comparator | Procedure: two ports video-assisted thoracoscopic surgeryvideo-assisted thoracoscopic surgery for NSCLC using two ports |
| three ports group | Active comparator | Procedure: three ports video-assisted thoracoscopic surgeryvideo-assisted thoracoscopic surgery for NSCLC using three ports |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with cT1-3N0-1M0 NSCLC; good cardiopulmonary function; prepared to undergo radical resection;
Key exclusion criteria (1 listed)
- patients with N3 or M1 NSCLC; poor cardiopulmonary function; not be prepared to undergo radical resection;
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 |
|---|---|---|
| uniport video-assisted thoracoscopic surgeryvideo-assisted thoracoscopic surgery for NSCLC using single port or two ports or three ports | Procedure or surgery | single port group |
| two ports video-assisted thoracoscopic surgeryvideo-assisted thoracoscopic surgery for NSCLC using two ports | Procedure or surgery | two ports group |
| three ports video-assisted thoracoscopic surgeryvideo-assisted thoracoscopic surgery for NSCLC using three ports | Procedure or surgery | three ports group |
Primary outcome
operative time
Time frame: 1 day
operative time in minutes
perioperative blood loss
Time frame: 1 day
perioperative blood loss in milliliter
conversion rate
Time frame: 1 day
conversion rate in proportion
duration of postoperative drainage
Time frame: within 5-7 days
duration of postoperative drainage in days
length of hospital stay
Time frame: within 5-7 days
length of hospital stay in days
visual analogue score of postoperative pain
Time frame: within 5-7 days
score
complications
Time frame: up to 3 months
complications in rate
2 secondary outcomes
overall survival
Time frame: up to 5 years
progression- free survival
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
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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.
Xiaogang Zhao, Doctor study director
The Second Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uniport video-assisted thoracoscopic surgery, two ports video-assisted thoracoscopic surgery and three ports video-assisted thoracoscopic surgery in people with Single-port Video-assisted Thoracoscopic Surgery, run by The Second Hospital of Shandong University at 1 site in China.
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 16 Nov 2022. 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 China. 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 Yunpeng Zhao, Doctor (+8618766188692, zyp_baggio@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operative time (time frame: 1 day). The study lists 7 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 16 Nov 2022.