Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

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.

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.

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.

ENB guided MWA combined with VATS

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.

sequential surgery

Hecheng Li, PhD, MD

Dingpei Han, PhD, MD

Hecheng LI, PhD, MD

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.

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

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 percentage of people with successful biopsy.

The proportion of patients with malignant biopsies in the overall population

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.

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

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

the duration of the operation in minutes.

number of death within 30 days after surgery.

complications above grade 3 that need to be treated during and after the operation according to the Clavien-Dindo Classification.

patients' quality of life by questionnaires according to EORTC QLQ-LC29.

forced expiratory volume in one second(FEV1).

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).

the patients in control group complete two operations

The overall cost of treatment include direct and indirect costs. Additional costs for hospitalization and surgery.

Sun Yat-sen University

Tang-Du Hospital

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Ruijin Hospital

Professor

Symptoms and General Pathology

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

Hematinics

All Drugs and Chemicals

Liver Extracts

Simultaneous surgery of colorectal cancer and synchronous liver metastases

Sequential surgeries of colorectal cancer and synchronous liver metastases

Simultaneous surgery

Sequential surgeries of colorectal cancer and synchronous liver metastases: the metastases surgery will be programmed 12 to 14 weeks after the primary tumour exeresis.

Sequential surgery

Karim Boudjema, MD, PhD

Jean-Luc Raoul, MD

Eric Bellissant, MD, PhD

The surgical strategy for the treatment of synchronous colorectal cancer liver metastases has not still been defined. The purpose of this study is to compare two treatment strategies in which liver resection is performed either during, or 12 to 14 weeks after the primary resection. Endpoints include the rate of severe complications and survival.

In France, 35 000 colorectal cancers are diagnosed each year, 15 to 25% of which with hepatic metastases. It is nowadays admitted that the complete resection of these hepatic metastases represents the only treatment that has been shown to increase survival. The aim of this study is to evaluate the efficacy/safety ratio of the liver surgery when performed simultaneously or at distance of the primitive tumour ablation. Patients are randomized to undergo liver surgery either during, or 12 to 14 weeks after the primary resection. The primary endpoint is the rate of patients with at least one severe complication within 60 days after surgery. Secondary endpoints evaluate long-term clinical outcomes, in particular recurrence-free survival.

Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases

Prospective Randomized Study Comparing the Morbidity and Mortality After Liver Resection for Synchronous Colorectal Cancer Metastases When Performed Either During or 12 to 14 Weeks After the Primary Resection

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ENB Guided MWA Combined With VATS Versus Sequential Surgery for Synchronous Bilateral Multiple Primary Lung Nodules	NCT05662553	Multiple Primar...	ENB guided MWA ... sequential surg...	18 Years - 80 Years	Ruijin Hospital
Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases	NCT00264979	Colorectal Canc... Hepatic Metasta...	Simultaneous su... Sequential surg...	18 Years -	Rennes University Hospital
Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases	NCT00264979	Colorectal Canc... Hepatic Metasta...	Simultaneous su... Sequential surg...	18 Years -	Rennes University Hospital

Spots Global Cancer Trial Database for sequential surgery