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

Uniportal Versus Triportal Thoracoscopic Lobectomy and Sublobectomy for Early Stage Lung Cancer: a Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Lung Neoplasms
• Intervention / Treatment: Procedure: Triportal pulmonary resection surgery; Procedure: Uniportal pulmonary resection surgery

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.

• Study Type: Interventional
• Enrollment (Anticipated): 356
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juwei Mu, MD; Phone Number: 7140 8610-87788495; Email: mujuwei@cicams.ac.cn

Study Locations

• China
  • Beijing, China, 110000
    • Recruiting
    • Beijing Chest Hospital
    • Contact: Zhidong Liu, MD
  • Beijing, China, 110000
    • Recruiting
    • Chinese PLA General Hospital
    • Contact: Yang Liu, MD
  • Shanghai, China, 200000
    • Recruiting
    • Fudan University Cancer Center
    • Contact: Jiaqing Xiang, MD
  • Guangdong
    • Guangzhou, Guangdong, China, 518000
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Lanjun Zhang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Triportal pulmonary resection surgery; Uniportal video-assisted thoracoscopic surgery
Active Comparator: 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.	Procedure: Uniportal pulmonary resection surgery; Triportal video-assisted thoracoscopic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative respiratory complications	These respiratory complications involve respiratory distress or failure after the operation with continuation of mechanical ventilation, pulmonary atelectasis requiring sputum suction by bronchoscopy, pneumonia requiring specific antibiotics confirmed by thoracic X-ray or CT scan of the thorax and a positive sputum culture, and acute respiratory distress syndrome.	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss	blood loss during the surgery	Intraoperation
Conversion rate	conversion to thoracotomy during surgery	Intraoperation
Lymph node dissection	During the surgery, lymph node dissection were performed. The number of removed lymph-nodes were recorded according to the postoperative pathological diagnosis, and the stations of the lymph node were recorded according to the International Association for the Study of Lung Cancer (IASLC) Lymph Node Map.	Intraoperation
Long term survival	five-year survival rates after surgery	5 year
Local recurrence	three-year local recurrence rate after surgery	3 years

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: Sun Yat-sen University; Fudan University; Chinese PLA General Hospital; Beijing Chest Hospital
• Investigators: Principal Investigator: Juwei Mu, MD, Collaborative Innovation Center for Cancer Medicine

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): April 1, 2018
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: September 23, 2016
• First Submitted That Met QC Criteria: October 12, 2016
• First Posted (Estimate): October 14, 2016

Study Record Updates

• Last Update Posted (Estimate): October 14, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: lung cancer; VATS; uniportal
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: ZLYXXTCX-201509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided