Video-Assisted Thoracic SurgeryPhase 3NCT03523468
Curative Effect and Quality of Life Between Uniportal and Open Sleeve Lobectomy for Central Type Lung Cancer
A Phase 3 study testing uniportal sleeve lobectomy and open sleeve lobectomy in people with Video-Assisted Thoracic Surgery and Lung Cancer, run by Lei Jiang at 1 site in China.
Trial summary
In surgical treatment decisions, locally advanced central lung cancer is the most difficult. When infiltrating into the trachea, conventional pneumonectomy cannot achieve the purpose of radical treatment.Pulmonary sleeve resection involves the removal of part of the main bronchus and can completely remove the tumor… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Video-Assisted Thoracic Surgery, Lung Cancer
- What is being tested?
- uniportal sleeve lobectomy and open sleeve lobectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2018to 30 Dec 2024
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The tumor is located in the opening of bronchus, or the edge of the tumor is <2 cm away from the opening of the bronchi;
- The distance between the edge of the tumor and the carina is >1.5 cm;
- Partial benign lesions or the presence of bronchial stenosis Patient.
Who cannot join
- Distant metastasis;
- Cardiopulmonary function cannot tolerate surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, 200020
jian chen, doctor, +8618817310041, yufuchenjian@163.com
lei jiang, doctor
About this study
Official title: Curative Effect and Quality of Life Between Uniportal Sleeve Lobectomy and Open-chest Sleeve Lobectomy for Central Type Lung Cancer: a Prospective Randomized Controlled Study
In surgical treatment decisions, locally advanced central lung cancer is the most difficult. When infiltrating into the trachea, conventional pneumonectomy cannot achieve the purpose of radical treatment.Pulmonary sleeve resection involves the removal of part of the main bronchus and can completely remove the tumor, as far as possible to retain normal lung function, fully embodies the surgical principle and is worthy of clinical promotion.this study intends to compare uniportal-sleeve and open-chest sleeve lobectomy for the treatment of central lung cancer, analyzing the curative effect and quality of life of postoperative patients on the basis of previous accumulation.
Read the detailed description
In surgical treatment decisions, locally advanced central lung cancer is the most difficult. Locally advanced central lung cancer refers to tumors that have recidivised adjacent organs and tissues, such as the esophagus, tracheal carina, pericardium, heart, large vessels, etc., with mediastinal lymph node metastases, but no distant metastases (such as bone) have been found by current examination methods. Adjacent hilar lymph nodes and blood vessels are easily invaded, so it is difficult to perform surgery and the resection rate is low. On the other hand, central lung cancer involving the opening of the main bronchus and upper lobe often requires pneumonectomy which would affect the quality of life. When infiltrating into the trachea, conventional pneumonectomy cannot achieve the purpose of radical treatment. The accepted principle of surgery is to maximize the removal of tumor tissue and to maximize the retention of healthy lung tissue. Pulmonary sleeve resection involves the removal of part of the main bronchus and can completely remove the tumor, as far as possible to retain normal lung function, fully embodies this surgical principle and is worthy of clinical promotion.
patients who are suitable for sleeve resection account for 5% to 13% of the total surgical volume. This also expands the indications for Video assisted thoracoscopic surgery (VATS). Some central lung cancer patients therefore could benefit from that, especially for elderly patients with poor cardiopulmonary function. However, central lung cancer sleeve resection performed by uniportal VATS is seldom reported, and it has been considered as a difficult and high-risk surgical method.
The Investigators' hospital has completed more than 300 cases of uniportal sleeve surgery, which has become the largest center for performing sleeve-surgery by uniportal VATS in the world.
Therefore, this study intends to compare uniportal-sleeve and open-chest sleeve lobectomy for the treatment of central lung cancer, analyzing the curative effect and quality of life of postoperative patients on the basis of previous accumulation. The Investigators' work would promote the usage of uniportal-sleeve lobectomy in the treatment of patients with locally advanced central lung cancer.
- Conditions
- Video-Assisted Thoracic Surgery, Lung Cancer
- Being tested
- uniportal sleeve lobectomy, open sleeve lobectomy
- Keywords
- VATS, Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uniportal sleeve lobectomyProcedure or surgery
central lung cancer sleeve resection performed by uniportal VATS
open sleeve lobectomyProcedure or surgery
central lung cancer sleeve resection performed by open chest
| Study group | Role | What they receive |
|---|---|---|
| uniportal sleeve lobectomy | Experimental | locally advanced central lung cancer resection by uniportal VATS sleeve lobectomy Receives: Procedure: uniportal sleeve lobectomy |
| open sleeve lobectomy | Active comparator | locally advanced central lung cancer resection by open chest sleeve lobectomy Receives: Procedure: open sleeve lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
visual analogue score (VAS-score) is to asses the development of acute and chronic pain after VATS surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain ".
Measured: 6 months
Quality of life
EORTC QLQ-C43 questionnaire is used.
Measured: 6 months
Secondary outcomes (1)
5 year survival
follow up for 5 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start15 May 2018
- Primary completion30 May 2024 (estimated)
- Study completion30 Dec 2024 (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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Jiang
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China
- Responsible party
- Sponsor-investigator, Lei Jiang, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523468
- Sponsor's protocol ID
- jianglei3
- Status last verified
- Apr 2023
- First submitted
- 2 May 2018
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curative Effect and Quality of Life Between Uniportal Sleeve Lobectomy and Open-chest Sleeve Lobectomy for Central Type Lung Cancer: a Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03523468
- Acronym / sponsor ID
- jianglei3
- Conditions
- Video-Assisted Thoracic Surgery, Lung Cancer
- Keywords
- VATS, Lung Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lei JiangUniversity, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China
- Study start
- 15 May 2018 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 14 May 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.
In surgical treatment decisions, locally advanced central lung cancer is the most difficult. When infiltrating into the trachea, conventional pneumonectomy cannot achieve the purpose of radical treatment.Pulmonary sleeve resection involves the removal of part of the main bronchus and can completely remove the tumor, as far as possible to retain normal lung function, fully embodies the surgical principle and is worthy of clinical promotion.this study intends to compare uniportal-sleeve and open-chest sleeve lobectomy for the treatment of central lung cancer, analyzing the curative effect and quality of life of postoperative patients on the basis of previous accumulation.
Detailed description
In surgical treatment decisions, locally advanced central lung cancer is the most difficult. Locally advanced central lung cancer refers to tumors that have recidivised adjacent organs and tissues, such as the esophagus, tracheal carina, pericardium, heart, large vessels, etc., with mediastinal lymph node metastases, but no distant metastases (such as bone) have been found by current examination methods. Adjacent hilar lymph nodes and blood vessels are easily invaded, so it is difficult to perform surgery and the resection rate is low. On the other hand, central lung cancer involving the opening of the main bronchus and upper lobe often requires pneumonectomy which would affect the quality of life. When infiltrating into the trachea, conventional pneumonectomy cannot achieve the purpose of radical treatment. The accepted principle of surgery is to maximize the removal of tumor tissue and to maximize the retention of healthy lung tissue. Pulmonary sleeve resection involves the removal of part of the main bronchus and can completely remove the tumor, as far as possible to retain normal lung function, fully embodies this surgical principle and is worthy of clinical promotion.
patients who are suitable for sleeve resection account for 5% to 13% of the total surgical volume. This also expands the indications for Video assisted thoracoscopic surgery (VATS). Some central lung cancer patients therefore could benefit from that, especially for elderly patients with poor cardiopulmonary function. However, central lung cancer sleeve resection performed by uniportal VATS is seldom reported, and it has been considered as a difficult and high-risk surgical method.
The Investigators' hospital has completed more than 300 cases of uniportal sleeve surgery, which has become the largest center for performing sleeve-surgery by uniportal VATS in the world.
Therefore, this study intends to compare uniportal-sleeve and open-chest sleeve lobectomy for the treatment of central lung cancer, analyzing the curative effect and quality of life of postoperative patients on the basis of previous accumulation. The Investigators' work would promote the usage of uniportal-sleeve lobectomy in the treatment of patients with locally advanced central lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| uniportal sleeve lobectomy | Experimental | Procedure: uniportal sleeve lobectomylocally advanced central lung cancer resection by uniportal VATS sleeve lobectomy |
| open sleeve lobectomy | Active comparator | Procedure: open sleeve lobectomylocally advanced central lung cancer resection by open chest sleeve lobectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The tumor is located in the opening of bronchus, or the edge of the tumor is <2 cm away from the opening of the bronchi;
- The distance between the edge of the tumor and the carina is >1.5 cm;
- Partial benign lesions or the presence of bronchial stenosis Patient.
Key exclusion criteria (2 listed)
- Distant metastasis;
- Cardiopulmonary function cannot tolerate surgery.
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 sleeve lobectomycentral lung cancer sleeve resection performed by uniportal VATS | Procedure or surgery | uniportal sleeve lobectomy |
| open sleeve lobectomycentral lung cancer sleeve resection performed by open chest | Procedure or surgery | open sleeve lobectomy |
Primary outcome
Postoperative pain
Time frame: 6 months
visual analogue score (VAS-score) is to asses the development of acute and chronic pain after VATS surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain ".
Quality of life
Time frame: 6 months
EORTC QLQ-C43 questionnaire is used.
1 secondary outcome
5 year survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- 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 Phase 3 study testing uniportal sleeve lobectomy and open sleeve lobectomy in people with Video-Assisted Thoracic Surgery and Lung Cancer, run by Lei Jiang 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 2 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 25 Apr 2023. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 6 months). 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 25 Apr 2023.