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

Primary Purpose

Lung Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Triportal pulmonary resection surgery
Uniportal pulmonary resection surgery
Sponsored by
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms focused on measuring uniportal, lung cancer, VATS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sun Yat-sen University Cancer CenterRecruiting
  • Beijing Chest HospitalRecruiting
  • Chinese PLA General HospitalRecruiting
  • Fudan University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Triportal pulmonary resection surgery

Uniportal pulmonary resection surgery

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Blood loss
blood loss during the surgery
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.
Long term survival
five-year survival rates after surgery
Local recurrence
three-year local recurrence rate after surgery
Conversion rate
conversion to thoracotomy during surgery

Full Information

First Posted
September 23, 2016
Last Updated
October 12, 2016
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborators
Sun Yat-sen University, Fudan University, Chinese PLA General Hospital, Beijing Chest Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02933294
Brief Title
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Collaborators
Sun Yat-sen University, Fudan University, Chinese PLA General Hospital, Beijing Chest Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms
Keywords
uniportal, lung cancer, VATS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
356 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Triportal pulmonary resection surgery
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Uniportal pulmonary resection surgery
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Triportal pulmonary resection surgery
Intervention Description
Uniportal video-assisted thoracoscopic surgery
Intervention Type
Procedure
Intervention Name(s)
Uniportal pulmonary resection surgery
Intervention Description
Triportal video-assisted thoracoscopic surgery
Primary Outcome Measure Information:
Title
Postoperative respiratory complications
Description
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.
Time Frame
30 days after surgery
Secondary Outcome Measure Information:
Title
Blood loss
Description
blood loss during the surgery
Time Frame
Intraoperation
Title
Lymph node dissection
Description
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.
Time Frame
Intraoperation
Title
Long term survival
Description
five-year survival rates after surgery
Time Frame
5 year
Title
Local recurrence
Description
three-year local recurrence rate after surgery
Time Frame
3 years
Title
Conversion rate
Description
conversion to thoracotomy during surgery
Time Frame
Intraoperation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juwei Mu, MD
Phone
8610-87788495
Ext
7140
Email
mujuwei@cicams.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juwei Mu, MD
Organizational Affiliation
Collaborative Innovation Center for Cancer Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lanjun Zhang, MD
Facility Name
Beijing Chest Hospital
City
Beijing
ZIP/Postal Code
110000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhidong Liu, MD
Facility Name
Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
110000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Liu, MD
Facility Name
Fudan University Cancer Center
City
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiaqing Xiang, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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