Clinical trial NCT02933294: Uniportal Versus Triportal Thoracoscopic Lobectomy and Sublobectomy for Early Stage Lung Cancer
Official title: Uniportal Versus Triportal Thoracoscopic Lobectomy and Sublobectomy for Early Stage Lung Cancer: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Neoplasms
Keywords: uniportal
lung cancer
VATS
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
name: Fudan University
name: Chinese PLA General Hospital
name: Beijing Chest Hospital
First posted: 2016-10-14
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Postoperative respiratory complications
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Blood loss
timeFrame: Intraoperation
measure: Lymph node dissection
timeFrame: Intraoperation
measure: Long term survival
timeFrame: 5 year
measure: Local recurrence
timeFrame: 3 years
measure: Conversion rate
timeFrame: Intraoperation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Beijing
country: China
facility: Beijing Chest Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Shanghai
country: China
facility: Fudan University Cancer Center
Study officials:
affiliation: Collaborative Innovation Center for Cancer Medicine
name: Juwei Mu, MD
role: PRINCIPAL_INVESTIGATOR
References: