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

NCT05662553 | Unknown

• 1 other identifier: RTS-016
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Primary Lung Cancer

Keywords

electromagnetic navigation bronchoscopy; microwave ablation; sequential surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  From the time of treatment to one month after operation

Secondary Outcomes (13)

• Objective response rate(ORR)

  One and three months after ablation

• Treatment-related side effects

  From the time of treatment to one month after operation

• The operation time

  During operation

• The intraoperative blood loss

  During operation

• Postoperative hospital stay (days)

  One months after treatment

Other Outcomes (2)

• Biopsy success rate

  During operation

• Biopsy positive rate

  During operation

Study Arms (2)

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.

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.

Procedure: sequential surgery

Interventions

ENB guided MWA combined with VATS PROCEDURE

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.

Ablation

sequential surgery PROCEDURE

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.

Surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ruijin Hospital: lead
• Sun Yat-sen University: collaborator
• Tang-Du Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Interventions

Thoracic Surgery, Video-Assisted

Intervention Hierarchy (Ancestors)

Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Hecheng LI, PhD, MD

  Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hecheng Li, PhD, MD

CONTACT

+8613917113402; lihecheng2000@hotmail.com

Dingpei Han, PhD, MD

CONTACT

_18017420216; dmhan1985@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 22, 2022
• Study Start: February 1, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)