Clinical trial NCT05662553: ENB Guided MWA Combined With VATS Versus Sequential Surgery for Synchronous Bilateral Multiple Primary Lung Nodules
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Primary Lung Cancer
Keywords: electromagnetic navigation bronchoscopy
microwave ablation
sequential surgery
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
name: Tang-Du Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
First posted: 2022-12-22
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Aged ≥18 years and ≤80 years;
2. The subjects are diagnosed synchronous bilateral multiple primary lung nodules by HRCT
3. The primary nodule is diagnosed as lung cancer by preoperative puncture or multidisciplinary discussion, which can be treated with radical surgery.
4. At least one secondary lesion (6mm≤diameter≤20mm, CTR\<0.5) is contralateral to the primary nodule，which need treatment after multidisciplinary discussion
5. The ipsilateral secondary lesions can be treated by sublobar resection at the same time
6. ECOG PS score 0-1
7. The subjects participate voluntarily and sign a written informed consent;

Exclusion Criteria:

1. Patients have contraindications of surgery or anesthesia
2. Patients are unable to undergo bronchoscopy
3. A contralateral secondary lesion is unreachable during ENB planning
4. There are large blood vessels 2 mm near the contralateral secondary lesion
5. Patients have severe bleeding tendency and coagulation dysfunction which cannot be improved in a short time
6. Patients have interstitial pneumonia, pulmonary fibrosis, or severe emphysema
7. Patients have diseases,like severe anemia, dehydration, severe nutritional and metabolic disorders, which cannot be cured or improved in a short time
8. Patients have severe systemic infection and fever (\>38.5°C)
9. Patients have other malignant tumors
10. Patients have participated in other clinical trials
11. Investigators consider the patient do not fit for the study

Primary outcomes:
measure: Total perioperative complication rates
timeFrame: From the time of treatment to one month after operation
Secondary outcomes:
measure: Objective response rate(ORR)
timeFrame: One and three months after ablation
measure: Treatment-related side effects
timeFrame: From the time of treatment to one month after operation
measure: The operation time
timeFrame: During operation
measure: The intraoperative blood loss
timeFrame: During operation
measure: Postoperative hospital stay (days)
timeFrame: One months after treatment
measure: Postoperative extubation time (days)
timeFrame: One months after treatment
measure: Mortality within 30 days after surgery
timeFrame: One month after treatment
measure: Complications (grade ≥3)
timeFrame: One and three months after treatment
measure: Life expectancy(EORTC QLQ-LC29)
timeFrame: One and three months and every year after treatment
measure: Lung function
timeFrame: One and three months and every year after treatment
measure: 3-year disease-free survival(DFS)
timeFrame: A follow-up period of 3 years
measure: The proportion of completed two operations
timeFrame: During operation, an average of 4 months
measure: The overall cost of treatment
timeFrame: During hospitalization, an average of 2 weeks
Other outcomes:
measure: Biopsy success rate
timeFrame: During operation
measure: Biopsy positive rate
timeFrame: During operation
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
name: Hecheng LI, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: