Curative Effect and Quality of Life Between Uniportal and Open Sleeve Lobectomy for Central Type Lung Cancer
Primary Purpose
Video-Assisted Thoracic Surgery, Lung Cancer
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
uniportal sleeve lobectomy
open sleeve lobectomy
Sponsored by
About this trial
This is an interventional treatment trial for Video-Assisted Thoracic Surgery focused on measuring VATS, Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- The tumor is located in the opening of bronchus, or the edge of the tumor is <2 cm away from the opening of the bronchi;
- The distance between the edge of the tumor and the carina is >1.5 cm;
- Partial benign lesions or the presence of bronchial stenosis Patient.
Exclusion Criteria:
- Distant metastasis;
- Cardiopulmonary function cannot tolerate surgery.
Sites / Locations
- Shanghai Pulmonary HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
uniportal sleeve lobectomy
open sleeve lobectomy
Arm Description
locally advanced central lung cancer resection by uniportal VATS sleeve lobectomy
locally advanced central lung cancer resection by open chest sleeve lobectomy
Outcomes
Primary Outcome Measures
Postoperative pain
visual analogue score (VAS-score) is to asses the development of acute and chronic pain after VATS surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain ".
Quality of life
EORTC QLQ-C43 questionnaire is used.
Secondary Outcome Measures
5 year survival
follow up for 5 years
Full Information
NCT ID
NCT03523468
First Posted
May 2, 2018
Last Updated
April 23, 2023
Sponsor
Lei Jiang
Collaborators
Shanghai Pulmonary Hospital, Shanghai, China
1. Study Identification
Unique Protocol Identification Number
NCT03523468
Brief Title
Curative Effect and Quality of Life Between Uniportal and Open Sleeve Lobectomy for Central Type Lung Cancer
Official Title
Curative Effect and Quality of Life Between Uniportal Sleeve Lobectomy and Open-chest Sleeve Lobectomy for Central Type Lung Cancer: a Prospective Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2018 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lei Jiang
Collaborators
Shanghai Pulmonary Hospital, Shanghai, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In surgical treatment decisions, locally advanced central lung cancer is the most difficult. When infiltrating into the trachea, conventional pneumonectomy cannot achieve the purpose of radical treatment.Pulmonary sleeve resection involves the removal of part of the main bronchus and can completely remove the tumor, as far as possible to retain normal lung function, fully embodies the surgical principle and is worthy of clinical promotion.this study intends to compare uniportal-sleeve and open-chest sleeve lobectomy for the treatment of central lung cancer, analyzing the curative effect and quality of life of postoperative patients on the basis of previous accumulation.
Detailed Description
In surgical treatment decisions, locally advanced central lung cancer is the most difficult. Locally advanced central lung cancer refers to tumors that have recidivised adjacent organs and tissues, such as the esophagus, tracheal carina, pericardium, heart, large vessels, etc., with mediastinal lymph node metastases, but no distant metastases (such as bone) have been found by current examination methods. Adjacent hilar lymph nodes and blood vessels are easily invaded, so it is difficult to perform surgery and the resection rate is low. On the other hand, central lung cancer involving the opening of the main bronchus and upper lobe often requires pneumonectomy which would affect the quality of life. When infiltrating into the trachea, conventional pneumonectomy cannot achieve the purpose of radical treatment. The accepted principle of surgery is to maximize the removal of tumor tissue and to maximize the retention of healthy lung tissue. Pulmonary sleeve resection involves the removal of part of the main bronchus and can completely remove the tumor, as far as possible to retain normal lung function, fully embodies this surgical principle and is worthy of clinical promotion.
patients who are suitable for sleeve resection account for 5% to 13% of the total surgical volume. This also expands the indications for Video assisted thoracoscopic surgery (VATS). Some central lung cancer patients therefore could benefit from that, especially for elderly patients with poor cardiopulmonary function. However, central lung cancer sleeve resection performed by uniportal VATS is seldom reported, and it has been considered as a difficult and high-risk surgical method.
The Investigators' hospital has completed more than 300 cases of uniportal sleeve surgery, which has become the largest center for performing sleeve-surgery by uniportal VATS in the world.
Therefore, this study intends to compare uniportal-sleeve and open-chest sleeve lobectomy for the treatment of central lung cancer, analyzing the curative effect and quality of life of postoperative patients on the basis of previous accumulation. The Investigators' work would promote the usage of uniportal-sleeve lobectomy in the treatment of patients with locally advanced central lung cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Video-Assisted Thoracic Surgery, Lung Cancer
Keywords
VATS, Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
uniportal sleeve lobectomy
Arm Type
Experimental
Arm Description
locally advanced central lung cancer resection by uniportal VATS sleeve lobectomy
Arm Title
open sleeve lobectomy
Arm Type
Active Comparator
Arm Description
locally advanced central lung cancer resection by open chest sleeve lobectomy
Intervention Type
Procedure
Intervention Name(s)
uniportal sleeve lobectomy
Intervention Description
central lung cancer sleeve resection performed by uniportal VATS
Intervention Type
Procedure
Intervention Name(s)
open sleeve lobectomy
Intervention Description
central lung cancer sleeve resection performed by open chest
Primary Outcome Measure Information:
Title
Postoperative pain
Description
visual analogue score (VAS-score) is to asses the development of acute and chronic pain after VATS surgery. 11 point numeric rating scale of 0 represented "no pain"and a score of 10 represented "worst pain ".
Time Frame
6 months
Title
Quality of life
Description
EORTC QLQ-C43 questionnaire is used.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
5 year survival
Description
follow up for 5 years
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The tumor is located in the opening of bronchus, or the edge of the tumor is <2 cm away from the opening of the bronchi;
The distance between the edge of the tumor and the carina is >1.5 cm;
Partial benign lesions or the presence of bronchial stenosis Patient.
Exclusion Criteria:
Distant metastasis;
Cardiopulmonary function cannot tolerate surgery.
Facility Information:
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
ZIP/Postal Code
200020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jian chen, doctor
Phone
+8618817310041
Email
yufuchenjian@163.com
First Name & Middle Initial & Last Name & Degree
lei jiang, doctor
First Name & Middle Initial & Last Name & Degree
jian chen, doctor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Curative Effect and Quality of Life Between Uniportal and Open Sleeve Lobectomy for Central Type Lung Cancer
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