Uniportal Versus Triportal Thoracoscopic Lobectomy and Sublobectomy for Early Stage Lung Cancer

NCT ID: NCT02933294

Last Updated: 2016-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 356 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2020-12-31

Brief Summary

Lung cancer is one of the most common cancers in the world. At present, surgical resection is still the standard treatment for early stage lung cancer. Triportal thoracoscopic lung resection is a routine surgically procedure for early stage lung cancer while uniportal thoracoscopic lung resection is developing rapidly in recent years. Although uniportal VATS pulmonary resection has been proven to be effective in preventing postoperative morbidities, there is still no ample evidences to demonstrate that uniportal VATS pulmonary resection is equal or superior to traditional triportal thoracoscopic pulmonary resection. The purpose of this multicenter randomized controlled trial study is to compare the uniportal VATS with traditional triportal VATS pulmonary resection in postoperative complications, long-term survival, lymph node dissection and local recurrence.

Detailed Description

Lung cancer is one of the most common cancers in the world，especially in China, where the mortality ranked first in malignant tumors whether for males or females. At present, VATS (Video-assisted thoracoscopic surgery) lobectomy is still the "gold standard" for the treatment of lung cancer. Triportal thoracoscopic lung resection is a routine surgically procedure for early stage lung cancer while uniportal thoracoscopic lung resection is developing rapidly in recent years. Retrospective study in recent years showed that the postoperative complication rate is similar between uniportal thoracoscopic surgery and triportal thoracoscopic surgery. Meanwhile, the incision is more pleasing, the inflammatory response may be milder and the hospitalization time may be shorter in the uniportal thoracoscopic surgery. But until now there is no result of the randomized controlled study on the effectiveness and the prognosis between uniportal thoracoscopic surgery and triportal thoracoscopic surgery to support this conclusion. The objective of this multicenter randomized controlled trial study is to compare the postoperative complications, long-term survival, local recurrence, other perioperative variables such as conversion rate, blood loss, lymph nodes retrieved and postoperative hospital stay between the triportal VATS pulmonary resection and uniportal VATS pulmonary resection on early stage lung cancer.

Conditions

Lung Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Triportal pulmonary resection surgery

Treated by traditional video assisted thoracoscopic three-port pulmonary resection in the centers with enough experience in VATS and the volume ≧50 cases each year.

Group Type: ACTIVE_COMPARATOR

Triportal pulmonary resection surgery

Intervention Type: PROCEDURE

Uniportal video-assisted thoracoscopic surgery

Uniportal pulmonary resection surgery

Treated by minimally invasive video assisted thoracoscopic single-port pulmonary resection in the centers with enough experience in VATS and the volume ≧50 cases each year.

Group Type: ACTIVE_COMPARATOR

Uniportal pulmonary resection surgery

Intervention Type: PROCEDURE

Triportal video-assisted thoracoscopic surgery

Interventions

Triportal pulmonary resection surgery

Uniportal video-assisted thoracoscopic surgery

Intervention Type: PROCEDURE

Uniportal pulmonary resection surgery

Triportal video-assisted thoracoscopic surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• age≥18 years;
• cT1- 2N0-1M0 diagnosed by chest CT, PET-CT before operation;
• No severe comorbidity, can tolerate anesthesia;
• ECOG PS scores≤2;
• The patients sign informed consents by themselves.

Exclusion Criteria

• Inability to tolerance of tracheal intubation and general anesthesia;
• ECOG PS scores>2;
• Severe comorbidities including: Angina occurs in 3 months, uncontrolled hypertension, Congestive heart failure, a history of myocardial infarction in 6 months before admission, severe arrhythmia, severe liver, kidney or other metabolic diseases.

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

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role: collaborator

Beijing Chest Hospital

OTHER

Sponsor Role: collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Ju-Wei Mu

MD，PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juwei Mu, MD

Role: PRINCIPAL_INVESTIGATOR

Collaborative Innovation Center for Cancer Medicine

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Beijing Chest Hospital

Beijing, , China

Site Status: RECRUITING

Chinese PLA General Hospital

Beijing, , China

Site Status: RECRUITING

Fudan University Cancer Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Juwei Mu, MD

Role: CONTACT

mujuwei@cicams.ac.cn

8610-87788495 ext. 7140

Facility Contacts

Lanjun Zhang, MD

Role: primary

Zhidong Liu, MD

Role: primary

Yang Liu, MD

Role: primary

Jiaqing Xiang, MD

Role: primary

Other Identifiers

ZLYXXTCX-201509

Identifier Type: -

Identifier Source: org_study_id