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

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02933294
• Other study ID #: ZLYXXTCX-201509
• Status: Recruiting
• Phase: N/A
• First received: September 23, 2016
• Last updated: October 12, 2016
• Start date: May 2015
• Est. completion date: December 2020

Study information

• Verified date: October 2016
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Juwei Mu, MD
• Phone: 8610-87788495
• Email: mujuwei[@]cicams.ac.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 356
• Est. completion date: December 2020
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

Procedure:
• Triportal pulmonary resection surgery
Uniportal video-assisted thoracoscopic surgery
• Uniportal pulmonary resection surgery
Triportal video-assisted thoracoscopic surgery

Locations

Country	Name	City	State
China	Beijing Chest Hospital	Beijing
China	Chinese PLA General Hospital	Beijing
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Fudan University Cancer Center	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing Chest Hospital, Chinese PLA General Hospital, Fudan University, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Blood loss	blood loss during the surgery	Intraoperation	Yes
Secondary	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	Yes
Secondary	Long term survival	five-year survival rates after surgery	5 year	Yes
Secondary	Local recurrence	three-year local recurrence rate after surgery	3 years	Yes
Secondary	Conversion rate	conversion to thoracotomy during surgery	Intraoperation	Yes