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
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:
• 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;
Locations
Other Locations
China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Hecheng Li, PhD, MD
lihecheng2000@hotmail.com
+8613917113402
Backup
Dingpei Han, PhD, MD
dmhan1985@163.com
_18017420216
Time Frame
Start Date:2023-02-01
Estimated Completion Date:2025-12-31
Participants
Target number of participants:172
Treatments
Experimental: Ablation
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.
Active_comparator: Surgery
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.