Non Small Cell Lung CancerMVUVLCNCT02462356
Multiple-portal VATS Versus Uniportal VATS Lobectomy for Non-small Cell Lung Cancer
A study testing Uniportal VATS and Conventional VATS in people with Non Small Cell Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study evaluate multiple-portal VATS and uniportal VATS lobectomy for NSCLC, half of participants will receive multiple VATS, while the other half will receive uniportal VATS lobectomy. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Uniportal VATS and Conventional VATS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Sep 2016
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical diagnosis of primary lung cancer with the age between 35 and 75 years old;
- Patients with Tumor size ≤5cm，clinically staged T1-2N0-1M0，prepared for lobectomy and mediastinal lymph node dissection;
- Patients with an American Society of Anesthesiology score of 0-1.
Who cannot join
- Patients with N2 or N3 positive or distant metastasis.
- Patients who had undergone Neoadjuvant chemotherapy.
- Patients with tumor invasion to the peripheral structures.
- Patients with previous history of thoracic operations.
- Patients with serious thoracic adhesion.
- Patients who will undergo Pneumonectomy, sleeve lobectomy, segmentectomy, wedge resection.
- Patients with preexisting chronic obstructive pulmonarydisease, asthma, or interstitial lung disease;
- Patients with cardiac, hepatic, or renal dysfunction;
Trial locations and contacts
1 site in 1 country.
China1 site
The second affiliated hospital Zhejiang university school of medicine
Hangzhou, Zhejiang, 310000
About this study
Official title: A Randomized Controlled Study: the Effect of Multiple-portal VATS Versus Conventional VATS Lobectomy for NSCLC
This study evaluate multiple-portal VATS and uniportal VATS lobectomy for NSCLC, half of participants will receive multiple VATS, while the other half will receive uniportal VATS lobectomy.
Read the detailed description
Conventional VATS and uniportal VATS lobectomy can be performed each for NSCLC. Conventional VATS lobectomy employ 3 or 4 ports for completing the operation. Usually the camera port is performed at the seventh or eighth intercostals space within the trocar, so it's easy to cause the intercostals nerve and vessel injure, and still create obvious pain.
However, the lobectomy for lung cancer can be accomplished with a single incision. According to the initial results, Uniportal VATS (UVATS) lobectomy procedure has been wide adopted by less acess trauma, relieve postoperative pain. But these were retrospective and descriptive, not randomized study. Further randomized control studies will be required to demonstrate that there are more benefits in UVATS techniques compared with conventional VATS for lobectomy.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Uniportal VATS, Conventional VATS
- Keywords
- CVATS, UVATS, perioperative effect, ergonomic influence
- 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.
Uniportal VATSProcedure or surgery
Uniportal VATS lobectomy and lymph node dissection will be performed in this group
Conventional VATSProcedure or surgery
Conventional VATS lobectomy and lymph node dissection will be performed in this group
| Study group | Role | What they receive |
|---|---|---|
| Conventional VATS | Active comparator | Via conventional VATS lobectomy and systematic lymph node dissection for lung cancer Receives: Procedure: Conventional VATS |
| Uniportal VATS | Experimental | Via uniportal VATS lobectomy and systematic lymph node dissection for lung cancer Receives: Procedure: Uniportal VATS |
What is being measured
The primary outcome is the main question the study is designed to answer.
short-term quality of life(EQ5D) between the two groups
To observe differences of short-term effects(bleeding volume during operation,operation time, hospital mortality, hospital stay and so on) between two groups.
Measured: Up to 6 month
Secondary outcomes (4)
intra-operative and postoperative complications
Surgical Complications include conversion rate, bleeding, air leakage, pain, cardiac arrhythmias, wound infection, pulmonary complications, pulmonary function will be measured.
Measured: form the day of surgery up to discharege (expected within 1 month)
lung function
lung function will be measured at pre-operative, 3 weeks, 3 months after surgery
Measured: pre-operative, 3 weeks, 3 months after surgery
Pain Scores after surgery
Pain Scores will be measured by Brief pain inventory
Measured: 1, 3 days and 1, 3 months after surgery
The surgeon's ergonomic influence during operation(blinks/min)
Spontaneous eye blink rate(NASA Task Load Index，NASA TLX)
Measured: The video is capture every 5 minutes and lasted for 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startDec 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junqiang Fan, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462356
- Sponsor's protocol ID
- LY15H160034
- Acronym
- MVUVLC
- Status last verified
- Apr 2016
- First submitted
- 27 May 2015
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Yao J, Chang Z, Zhu L, Fan J. Uniportal versus multiportal thoracoscopic lobectomy: Ergonomic evaluation and perioperative outcomes from a randomized and controlled trial. Medicine (Baltimore). 2020 Oct 16;99(42):e22719. doi: 10.1097/MD.0000000000022719.
PubMed 33080728
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study: the Effect of Multiple-portal VATS Versus Conventional VATS Lobectomy for NSCLC
- ClinicalTrials.gov ID
- NCT02462356
- Acronym / sponsor ID
- MVUVLC / LY15H160034
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- CVATS, UVATS, perioperative effect, ergonomic influence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 4 Jun 2015 (estimated)
- 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.
This study evaluate multiple-portal VATS and uniportal VATS lobectomy for NSCLC, half of participants will receive multiple VATS, while the other half will receive uniportal VATS lobectomy.
Detailed description
Conventional VATS and uniportal VATS lobectomy can be performed each for NSCLC. Conventional VATS lobectomy employ 3 or 4 ports for completing the operation. Usually the camera port is performed at the seventh or eighth intercostals space within the trocar, so it's easy to cause the intercostals nerve and vessel injure, and still create obvious pain.
However, the lobectomy for lung cancer can be accomplished with a single incision. According to the initial results, Uniportal VATS (UVATS) lobectomy procedure has been wide adopted by less acess trauma, relieve postoperative pain. But these were retrospective and descriptive, not randomized study. Further randomized control studies will be required to demonstrate that there are more benefits in UVATS techniques compared with conventional VATS for lobectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional VATS | Active comparator | Procedure: Conventional VATSVia conventional VATS lobectomy and systematic lymph node dissection for lung cancer |
| Uniportal VATS | Experimental | Procedure: Uniportal VATSVia uniportal VATS lobectomy and systematic lymph node dissection for lung cancer |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with clinical diagnosis of primary lung cancer with the age between 35 and 75 years old;
- Patients with Tumor size ≤5cm，clinically staged T1-2N0-1M0，prepared for lobectomy and mediastinal lymph node dissection;
- Patients with an American Society of Anesthesiology score of 0-1.
Key exclusion criteria (8 listed)
- Patients with N2 or N3 positive or distant metastasis.
- Patients who had undergone Neoadjuvant chemotherapy.
- Patients with tumor invasion to the peripheral structures.
- Patients with previous history of thoracic operations.
- Patients with serious thoracic adhesion.
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 |
|---|---|---|
| Uniportal VATSUniportal VATS lobectomy and lymph node dissection will be performed in this group | Procedure or surgery | Uniportal VATS |
| Conventional VATSConventional VATS lobectomy and lymph node dissection will be performed in this group | Procedure or surgery | Conventional VATS |
Primary outcome
short-term quality of life(EQ5D) between the two groups
Time frame: Up to 6 month
To observe differences of short-term effects(bleeding volume during operation,operation time, hospital mortality, hospital stay and so on) between two groups.
4 secondary outcomes
intra-operative and postoperative complications
Time frame: form the day of surgery up to discharege (expected within 1 month)
lung function
Time frame: pre-operative, 3 weeks, 3 months after surgery
Pain Scores after surgery
Time frame: 1, 3 days and 1, 3 months after surgery
The surgeon's ergonomic influence during operation(blinks/min)
Time frame: The video is capture every 5 minutes and lasted for 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Derived from this study: PubMed 33080728Yao J, Chang Z, Zhu L, Fan J. Uniportal versus multiportal thoracoscopic lobectomy: Ergonomic evaluation and perioperative outcomes from a randomized and controlled trial. Medicine (Baltimore). 2020 Oct 16;99(42):e22719. doi: 10.1097/MD.0000000000022719.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uniportal VATS and Conventional VATS in people with Non Small Cell Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 inclusion and 8 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 15 Apr 2016. 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?
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?
short-term quality of life(EQ5D) between the two groups (time frame: Up to 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02462356, which also lists 1 linked publication.
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 15 Apr 2016.