Multiple Primary Lung CancerNCT05662553
ENB Guided MWA Combined With VATS Versus Sequential Surgery for Synchronous Bilateral Multiple Primary Lung Nodules
A study testing ENB guided MWA combined with VATS and sequential surgery in people with Multiple Primary Lung Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety and efficacy of ENB guided MWA combined with VATS versus sequential surgery for synchronous bilateral multiple primary lung nodules. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Primary Lung Cancer
- What is being tested?
- ENB guided MWA combined with VATS and sequential surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 31 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥18 years and ≤80 years;
- The subjects are diagnosed synchronous bilateral multiple primary lung nodules by HRCT
- The primary nodule is diagnosed as lung cancer by preoperative puncture or multidisciplinary discussion, which can be treated with radical surgery.
- At least one secondary lesion (6mm≤diameter≤20mm, CTR<0.5) is contralateral to the primary nodule，which need treatment after multidisciplinary discussion
- The ipsilateral secondary lesions can be treated by sublobar resection at the same time
- ECOG PS score 0-1
- The subjects participate voluntarily and sign a written informed consent;
Who cannot join
- Patients have contraindications of surgery or anesthesia
- Patients are unable to undergo bronchoscopy
- A contralateral secondary lesion is unreachable during ENB planning
- There are large blood vessels 2 mm near the contralateral secondary lesion
- Patients have severe bleeding tendency and coagulation dysfunction which cannot be improved in a short time
- Patients have interstitial pneumonia, pulmonary fibrosis, or severe emphysema
Show all 11Show fewer
- Patients have diseases,like severe anemia, dehydration, severe nutritional and metabolic disorders, which cannot be cured or improved in a short time
- Patients have severe systemic infection and fever (>38.5°C)
- Patients have other malignant tumors
- Patients have participated in other clinical trials
- Investigators consider the patient do not fit for the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000
Hecheng Li, PhD, MD, +8613917113402, lihecheng2000@hotmail.com
About this study
Official title: A Prospective, Multi-center, Randomized Controlled Clinical Study of ENB Guided MWA Combined With VATS Versus Sequential Surgery for Synchronous Bilateral Multiple Primary Lung Nodules
The goal of this clinical trial is to evaluate the safety and efficacy of ENB guided MWA combined with VATS versus sequential surgery for synchronous bilateral multiple primary lung nodules. Participants will be divided into two group.One group will accepte treatment of ENB guided MWA combined with VATS,another will accepted sequential surgery.
Read the detailed description
Lung cancer is one of the most common cancers and the leading cause of cancer-related death worldwide. With the improvement of people's health awareness and the wide application of LDCT and HRCT, the incidence of multiple primary lung cancer is increasing, especially the synchronous bilateral multiple primary pulmonary nodules are the difficulties in the treatment of pulmonary nodules. Bilateral sequential surgery is associated with higher intraoperative risks, higher rates of postoperative complications, and lower postoperative quality of life. At present, a small number of recent retrospective studies have shown that microwave ablation(MWA) guided by electromagnetic navigation bronchoscopy(ENB) combined with video-assisted thoracic surgery(VATS) treatment can effectively treat bilateral multiple primary pulmonary nodules, which not only has a low complication rate, but also can avoid secondary surgery.
Based on previous studies, the research plans to conduct a prospective, multi-center, randomized controlled study to evaluate the safety and efficacy of ENB guided MWA combined with VATS versus sequential surgery for synchronous bilateral multiple primary lung nodules, as well as its potential value as a new treatment option for these participants.
- Conditions
- Multiple Primary Lung Cancer
- Being tested
- ENB guided MWA combined with VATS, sequential surgery
- Keywords
- electromagnetic navigation bronchoscopy, microwave ablation, sequential surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENB guided MWA combined with VATSProcedure or surgery
ENB guide MWA combine ENB, microwave ablation and 3D reconstruction technology, and guide the probe in the airway to the target lesion for ablation therapy, which is safe and effective. For patients with synchronous bilateral multiple primary pulmonary nodules, ENB guide MWA combined with VATS treatment can not only avoid the risk of bilateral surgery, but also complete the "one-stop" treatment, which is a new treatment mode.
sequential surgeryProcedure or surgery
Bilateral surgery is a traditional treatment, but it will lead to increased intraoperative risk and postoperative complication rate, and more likely to lead to postoperative complications such as decreased quality of life and cardiopulmonary dysfunction.
| Study group | Role | What they receive |
|---|---|---|
| Ablation | Experimental | After randomization, the enrolled patients in this arm should be performed path simulation under ENB with preoperative CT. On the operation day, single-cavity intubation will be carried out first, and the secondary lesion will be reached through the planned path. After that，the biopsy tissue of the lesion will be sent to ROSE for detection. If malignant，the ablation will be performed，and the location, energy and ablation time will be adjusted according to intraoperative CT. After ablation, radical surgery will be performed on the primary lesion. Receives: Procedure: ENB guided MWA combined with VATS |
| Surgery | Active comparator | The control group will undergo VATS treatment on the primary lesion on the day of operation, and will be re-admitted to the hospital after discharge and recovery (3-4 months) for contralateral secondary lesion surgery. Receives: Procedure: sequential surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total perioperative complication rates
Complications refer to operation-related adverse events during and after the operation according to the Clavien-Dindo Classification, including pulmonary infection, Broncho-pulmonary hemorrhage, respiratory failure, pleural effusion, pneumothorax, persistent lung leak, arrhythmia, wound infection, death.
Measured: From the time of treatment to one month after operation
Secondary outcomes (13)
Objective response rate(ORR)
Objective response rate（ORR）is the proportion of patients with complete responses and partial responses.
Measured: One and three months after ablation
Treatment-related side effects
Number of participants with treatment-related adverse events as assessed by CTCAE 5.0.
Measured: From the time of treatment to one month after operation
The operation time
the duration of the operation in minutes.
Measured: During operation
The intraoperative blood loss
the volume of blood loss in ml.
Measured: During operation
Postoperative hospital stay (days)
The time of hospitalization in days.
Measured: One months after treatment
Postoperative extubation time (days)
The duration of chest drainage in days.
Measured: One months after treatment
Mortality within 30 days after surgery
number of death within 30 days after surgery.
Measured: One month after treatment
Complications (grade ≥3)
complications above grade 3 that need to be treated during and after the operation according to the Clavien-Dindo Classification.
Measured: One and three months after treatment
Life expectancy(EORTC QLQ-LC29)
patients' quality of life by questionnaires according to EORTC QLQ-LC29.
Measured: One and three months and every year after treatment
Lung function
forced expiratory volume in one second(FEV1).
Measured: One and three months and every year after treatment
3-year disease-free survival(DFS)
DFS : the time from surgical resection to clinically confirmed local recurrence, distant metastasis, second primary tumor diagnosis, or patient death (control group since the second operation).
Measured: A follow-up period of 3 years
The proportion of completed two operations
the patients in control group complete two operations
Measured: During operation, an average of 4 months
The overall cost of treatment
The overall cost of treatment include direct and indirect costs. Additional costs for hospitalization and surgery.
Measured: During hospitalization, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start1 Feb 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Primary Lung CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-sen University, Tang-Du Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Hecheng Li M.D., Ph.D, Ruijin Hospital
- Investigators
- Hecheng LI, PhD, MD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662553
- Sponsor's protocol ID
- RTS-016
- Status last verified
- Jan 2023
- First submitted
- 28 Nov 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized Controlled Clinical Study of ENB Guided MWA Combined With VATS Versus Sequential Surgery for Synchronous Bilateral Multiple Primary Lung Nodules
- ClinicalTrials.gov ID
- NCT05662553
- Acronym / sponsor ID
- RTS-016
- Conditions
- Multiple Primary Lung Cancer
- Keywords
- electromagnetic navigation bronchoscopy, microwave ablation, sequential surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Sun Yat-sen University, Tang-Du Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Dec 2022 (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 goal of this clinical trial is to evaluate the safety and efficacy of ENB guided MWA combined with VATS versus sequential surgery for synchronous bilateral multiple primary lung nodules. Participants will be divided into two group.One group will accepte treatment of ENB guided MWA combined with VATS,another will accepted sequential surgery.
Detailed description
Lung cancer is one of the most common cancers and the leading cause of cancer-related death worldwide. With the improvement of people's health awareness and the wide application of LDCT and HRCT, the incidence of multiple primary lung cancer is increasing, especially the synchronous bilateral multiple primary pulmonary nodules are the difficulties in the treatment of pulmonary nodules. Bilateral sequential surgery is associated with higher intraoperative risks, higher rates of postoperative complications, and lower postoperative quality of life. At present, a small number of recent retrospective studies have shown that microwave ablation(MWA) guided by electromagnetic navigation bronchoscopy(ENB) combined with video-assisted thoracic surgery(VATS) treatment can effectively treat bilateral multiple primary pulmonary nodules, which not only has a low complication rate, but also can avoid secondary surgery.
Based on previous studies, the research plans to conduct a prospective, multi-center, randomized controlled study to evaluate the safety and efficacy of ENB guided MWA combined with VATS versus sequential surgery for synchronous bilateral multiple primary lung nodules, as well as its potential value as a new treatment option for these participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablation | Experimental | Procedure: ENB guided MWA combined with VATSAfter randomization, the enrolled patients in this arm should be performed path simulation under ENB with preoperative CT. On the operation day, single-cavity intubation will be carried out first, and the secondary lesion will be reached through the planned path. After that，the biopsy tissue of the lesion will be sent to ROSE for detection. If malignant，the ablation will be performed，and the location, energy and ablation time will be adjusted according to intraoperative CT. After ablation, radical surgery will be performed on the primary lesion. |
| Surgery | Active comparator | Procedure: sequential surgeryThe control group will undergo VATS treatment on the primary lesion on the day of operation, and will be re-admitted to the hospital after discharge and recovery (3-4 months) for contralateral secondary lesion surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged ≥18 years and ≤80 years;
- The subjects are diagnosed synchronous bilateral multiple primary lung nodules by HRCT
- The primary nodule is diagnosed as lung cancer by preoperative puncture or multidisciplinary discussion, which can be treated with radical surgery.
- At least one secondary lesion (6mm≤diameter≤20mm, CTR<0.5) is contralateral to the primary nodule，which need treatment after multidisciplinary discussion
- The ipsilateral secondary lesions can be treated by sublobar resection at the same time
Key exclusion criteria (11 listed)
- Patients have contraindications of surgery or anesthesia
- Patients are unable to undergo bronchoscopy
- A contralateral secondary lesion is unreachable during ENB planning
- There are large blood vessels 2 mm near the contralateral secondary lesion
- Patients have severe bleeding tendency and coagulation dysfunction which cannot be improved in a short time
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 |
|---|---|---|
| ENB guided MWA combined with VATSENB guide MWA combine ENB, microwave ablation and 3D reconstruction technology, and guide the probe in the airway to the target lesion for ablation therapy, which is safe and effective. For patients with synchronous bilateral multiple primary pulmonary nodules, ENB guide MWA combined with VATS treatment can not only avoid the risk of bilateral surgery, but also complete the "one-stop" treatment, which is a new treatment mode. | Procedure or surgery | Ablation |
| sequential surgeryBilateral surgery is a traditional treatment, but it will lead to increased intraoperative risk and postoperative complication rate, and more likely to lead to postoperative complications such as decreased quality of life and cardiopulmonary dysfunction. | Procedure or surgery | Surgery |
Primary outcome
Total perioperative complication rates
Time frame: From the time of treatment to one month after operation
Complications refer to operation-related adverse events during and after the operation according to the Clavien-Dindo Classification, including pulmonary infection, Broncho-pulmonary hemorrhage, respiratory failure, pleural effusion, pneumothorax, persistent lung leak, arrhythmia, wound infection, death.
13 secondary outcomes
Objective response rate(ORR)
Time frame: One and three months after ablation
Treatment-related side effects
Time frame: From the time of treatment to one month after operation
The operation time
Time frame: During operation
The intraoperative blood loss
Time frame: During operation
Postoperative hospital stay (days)
Time frame: One months after treatment
Postoperative extubation time (days)
Time frame: One months after treatment
Mortality within 30 days after surgery
Time frame: One month after treatment
Complications (grade ≥3)
Time frame: One and three months after treatment
Life expectancy(EORTC QLQ-LC29)
Time frame: One and three months and every year after treatment
Lung function
Time frame: One and three months and every year after treatment
3-year disease-free survival(DFS)
Time frame: A follow-up period of 3 years
The proportion of completed two operations
Time frame: During operation, an average of 4 months
The overall cost of treatment
Time frame: During hospitalization, an average of 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Hecheng LI, PhD, MD principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENB guided MWA combined with VATS and sequential surgery in people with Multiple Primary Lung Cancer, run by Ruijin Hospital 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 7 inclusion and 11 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 10 Jan 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.
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 Hecheng Li, PhD, MD (+8613917113402, lihecheng2000@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total perioperative complication rates (time frame: From the time of treatment to one month after operation). 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 10 Jan 2023; AzTrials last refreshed its copy on 31 Oct 2026.