Ignite Creation Date:
2024-05-06 @ 8:18 AM
Last Modification Date:
2024-10-26 @ 11:59 AM
Study NCT ID:
NCT02718365
Status:
RECRUITING
Last Update Posted:
2020-10-12
First Post:
2015-10-04
Brief Title:
Comparison Between Wedge Resection and Segmentectomy for Ground Glass Opacity- Dominant Stage IA NSCLC
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
A Multi-center Prospective Randomized Controlled Clinical Trial Comparison Between Wedge Resection and Segmentectomy in the Surgical Treatment of Ground Glass Opacity-dominant Stage IA Non-small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate whether the long-term outcome and safety of wedge resection are comparable to segmentectomy for the surgical treatment of early stage IA non-small cell lung cancer NSCLC Zhang et al performed a meta-analysis of 53 studies and suggested that sublobectomy achieved a survival rate comparable to lobectomy in a selected population of patients with Stage I NSCLC However one critical question needs to be addressed that is does sublobectomy require segmentectomy or wedge resection Cho et al reported that for pulmonary ground glass opacity GGO nodules Stage IA NSCLC wedge resection achieved a 5-year survival rate of 986 in the pure GGO group and 955 in the mixed GGO group Cho et al cautioned against performing wedge resection for mixed GGO nodules with GGO component 75 due to the high recurrence rate When radiology shows that the GGO component is 75 pathology usually finds that the lesions are non-invasive Therefore these lesions are potential candidates for wedge resection This randomized clinical trial is to assess whether wedge resection can be established as a standard treatment for Stage IA NSCLC with tumor size 2 cm and GGO component 75
Detailed Description:
1 Selection procedures When a case meets the inclusion criteria and does not meet exclusion criteria the research assistant of each research participating center will fill out the Eligibility Application Form and submit it to the Research Committee for reviewing whether the case is eligible for the trial The following rules will be strictly applied
1 The application and confirmation of eligibility should be preoperatively completed and any postoperative application will not be accepted
2 If the Eligibility Application Form is incomplete it must be returned to be completed otherwise it will not be accepted
3 After being approved by the Research Committee the case will be assigned a number Baseline Number BN and an Eligibility Confirmation Notice will be sent to the applicant
4 After each research participating center receives the Eligibility Confirmation Notice the research assistant of each center is responsible for the custody and documentation
5 Once being selected for registration the content of the Eligibility Application Form will be input into the database and the cases eligibility is not allowed to be cancelled that is the relevant information cannot be deleted from the database unless the patient declines the information to be used in this study
6 The data center will not accept any duplicated applications for any single case If this happens the first registered data will be used ie the first time BN
7 In cases of duplicated applications or registration errors the research assistant of each research participating center shall contact the Research Committee as soon as possible for liaison and documentation
2 Qualification of the responsible surgeons who participate in this study the responsible surgeons who participate in this study shall meet the following qualifications 1 at least have completed 20 cases of VATS segmentectomy and 2 have passed the blind review of hisher video records of the surgery
3 Criteria for confirming operation quality for the case to be included in the analysis the responsible surgeon shall submit the video or photo recordings of the surgery to the Research Committee for evaluation of the surgical procedures
4 Rules for handling the excluded patients identified intraoperatively if the responsible surgeon finds that the patient in operation meets the exclusion criteria the case will be excluded and the surgeon will follow the routine clinical practice of the research participating center to decide subsequent treatments that are not specified in this study protocol
1 The application and confirmation of eligibility should be preoperatively completed and any postoperative application will not be accepted
2 If the Eligibility Application Form is incomplete it must be returned to be completed otherwise it will not be accepted
3 After being approved by the Research Committee the case will be assigned a number Baseline Number BN and an Eligibility Confirmation Notice will be sent to the applicant
4 After each research participating center receives the Eligibility Confirmation Notice the research assistant of each center is responsible for the custody and documentation
5 Once being selected for registration the content of the Eligibility Application Form will be input into the database and the cases eligibility is not allowed to be cancelled that is the relevant information cannot be deleted from the database unless the patient declines the information to be used in this study
6 The data center will not accept any duplicated applications for any single case If this happens the first registered data will be used ie the first time BN
7 In cases of duplicated applications or registration errors the research assistant of each research participating center shall contact the Research Committee as soon as possible for liaison and documentation
2 Qualification of the responsible surgeons who participate in this study the responsible surgeons who participate in this study shall meet the following qualifications 1 at least have completed 20 cases of VATS segmentectomy and 2 have passed the blind review of hisher video records of the surgery
3 Criteria for confirming operation quality for the case to be included in the analysis the responsible surgeon shall submit the video or photo recordings of the surgery to the Research Committee for evaluation of the surgical procedures
4 Rules for handling the excluded patients identified intraoperatively if the responsible surgeon finds that the patient in operation meets the exclusion criteria the case will be excluded and the surgeon will follow the routine clinical practice of the research participating center to decide subsequent treatments that are not specified in this study protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None