VATS VS. Open Thoracic Surgery for Stage II - III Lung Cancer

NCT ID: NCT04009915

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2025-12-30

Brief Summary

For patients with stage I lung cancer, the NCCN guidelines point out that if the patient has no contraindications for anatomy and surgery, as long as it does not violate the standard of tumor treatment and the principle of thoracic surgery, it is highly recommended of VATS or minimally invasive surgery.

Although previous papers seem to have obvious advantages, there is a lack of clinical prospective data from patients with stage II-III lung cancer, and especially in the prevalence of uniportal VATS, there is still no objective analysis of this hypothesis. Therefore, the investigators plan to conduct a randomized, prospective study to compare perioperative complications, postoperative pain, life quality, lung function recovery, tumor-free survival rate, etc., in lobectomy for stage II-III lung cancer patients with VATS and thoracotomy.

Detailed Description

Lung cancer is the most common malignant tumor in the world. Surgical treatment is the first and most important treatment for lung cancer. It can completely remove the primary lesions of lung cancer and metastasis of lymph nodes to achieve clinical cure. Opening the chest into the chest allows for an excellent surgical field of view, but it is usually necessary to divide the pectoralis and separate the ribs. To prevent these shortcomings, in the early 1990s, video-assisted thoracoscopic surgery (VATS) was first applied to anatomical pneumonectomy and proved to be safe and feasible. Nowadays, for patients with stage I lung cancer, the NCCN guidelines point out that if the patient has no contraindications for anatomy and surgery, as long as it does not violate the standard of tumor treatment and the principle of thoracic surgery, it is highly recommended of VATS or minimally invasive surgery.

For lung cancer, the benefit of VATS over open surgery is mainly due to the reduction of surgical trauma and the relative maintenance of chest integrity, the reduction of immune function, the reduction of postoperative pain, and the preservation of lung and shoulder function. What's more, the incidence of postoperative complications is reduced, patients recover faster, hospitalization is short, and normal activities are restored early. Although previous papers seem to have obvious advantages, there is a lack of clinical prospective data from patients with stage II-III lung cancer, and especially in the prevalence of uniportal VATS, there is still no objective analysis of this hypothesis.

Therefore, the investigators plan to conduct a randomized, prospective study to compare perioperative complications, postoperative pain, life quality, lung function recovery, tumor-free survival rate, etc., in lobectomy for stage II-III lung cancer patients with VATS and thoracotomy. the investigators would complete the real and effective accumulation of data through strict enrollment, detailed records, and regular follow-up, in order to provide suggestions for the development of new guidelines.

Conditions

Lung Cancer; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

VATS

Patients undergo a standard VATS operation for stage II-III lung cancer

Group Type: EXPERIMENTAL

VATS

Intervention Type: PROCEDURE

Patients undergo a standard VATS operation for stage II-III lung cancer called a lobectomy.

open surgery

Patients undergo a standard open operation for stage II-III lung cancer

Group Type: ACTIVE_COMPARATOR

Open surgery

Intervention Type: PROCEDURE

Patients undergo a standard open operation for stage II-III lung cancer called a lobectomy.

Interventions

VATS

Patients undergo a standard VATS operation for stage II-III lung cancer called a lobectomy.

Intervention Type: PROCEDURE

Open surgery

Patients undergo a standard open operation for stage II-III lung cancer called a lobectomy.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of stage II-III non-small cell lung cancer by CT and PET-CT and requiring radical surgery for lung cancer;

2. Age ≥ 18 years.

Exclusion Criteria

1. palliative surgery;

2. previous thoracic surgery;

3. chest wall resection;

4. Pancoast tumors;

5. reconstruction of carina.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Pulmonary Hospital, Shanghai, China

OTHER

Sponsor Role: lead

Responsible Party

duan liang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Pulmonary Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

liang duan, doctor

Role: CONTACT

duan-liang@163.com

+8613044634176 ext. +8613044634176

Facility Contacts

liang duan

Role: primary

duan-liang@163.com

+8613044634176

Other Identifiers

Duanliang 1

Identifier Type: -

Identifier Source: org_study_id