ENB Guided MWA Combined With VATS Versus Sequential Surgery for Synchronous Bilateral Multiple Primary Lung Nodules

Ruijin Hospital172 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

172

Conditions

Multiple Primary Lung Cancer

Interventions

ENB guided MWA combined with VATSPROCEDURE

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

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: From the time of treatment to one month after operation

Secondary Outcomes

Objective response rate(ORR)

Objective response rate（ORR）is the proportion of patients with complete responses and partial responses.

Time frame: One and three months after ablation

Treatment-related side effects

Number of participants with treatment-related adverse events as assessed by CTCAE 5.0.

Time frame: From the time of treatment to one month after operation

The operation time

the duration of the operation in minutes.

Time frame: During operation

The intraoperative blood loss

the volume of blood loss in ml.

Time frame: During operation

Postoperative hospital stay (days)

The time of hospitalization in days.

Time frame: One months after treatment

Postoperative extubation time (days)

The duration of chest drainage in days.

Time frame: One months after treatment

Mortality within 30 days after surgery

Central Contacts

Hecheng Li, PhD, MD

CONTACT

+8613917113402 lihecheng2000@hotmail.com

Dingpei Han, PhD, MD

CONTACT

_18017420216 dmhan1985@163.com

Data from ClinicalTrials.gov

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