Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516796
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Omitting of Lymphadenectomy is Acceptable for Lung Cancer Smaller Than 6 mm in Solid Size
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Omitting of Lymphadenectomy is Acceptable for Lung Cancer Smaller Than 6 mm in Solid Size
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Many studies suggested that selective lymph node sampling was acceptable for specific non-small cell lung cancer NSCLC This study aimed to evaluate the acceptability of omitting of lymphadenectomy for selected NSCLC
Patients with small-sized 2 cm NSCLC who underwent surgical resection between 2009 and 2022 were retrospectively screened
Patients with small-sized 2 cm NSCLC who underwent surgical resection between 2009 and 2022 were retrospectively screened
Detailed Description:
Many studies suggested that selective lymph node sampling was acceptable for specific non-small cell lung cancer NSCLC This study aimed to evaluate the acceptability of omitting of lymphadenectomy for selected NSCLC
Patients with small-sized 2 cm NSCLC who underwent surgical resection between 2009 and 2022 were retrospectively screened The characteristics of patients with nodal metastasis were demonstrated For selected patients the perioperative and long-term outcomes of patients with and without lymphadenectomy were compared Log-rank test and Cox regression analysis were adopted for prognostic evaluation
A total of 2713 NSCLC patients were enrolled and 75 of them 276 had nodal involvement None of patients with pure ground glass opacity 0945 had nodal metastasis while 14 patients with part-solid 141260 111 and 61 patients with solid nodules 61508 1201 had nodal involvement Patients with nodal metastasis had a minimum solid size of 6 mm NSCLC with solid components 6 mm n1588 had no nodal metastasis Of them 339 patients underwent sublobar resection without lymphadenectomy SRN0 1056 subjects received sublobar resection with lymphadenectomy SRN1 and 190 patients received lobectomy plus lymphadenectomy LRN1 Patients with SRN0 had a shorter operating time less volume of drainage a lower incidence of chylothorax 0 vs 06 vs 21 P0012 and air leakage as well as a shorter postoperative hospitalization 3 vs 4 vs 4 days P0001 than those with SRN1 or LRN1 During a median follow-up of 61 months no patient with SRN0 was dead or tumor recurrent The 5-year recurrence-free survival was 100 992 and 985 for patients with SRN0 SRN1 and LRN1 respectively P0370
Patients with small-sized 2 cm NSCLC who underwent surgical resection between 2009 and 2022 were retrospectively screened The characteristics of patients with nodal metastasis were demonstrated For selected patients the perioperative and long-term outcomes of patients with and without lymphadenectomy were compared Log-rank test and Cox regression analysis were adopted for prognostic evaluation
A total of 2713 NSCLC patients were enrolled and 75 of them 276 had nodal involvement None of patients with pure ground glass opacity 0945 had nodal metastasis while 14 patients with part-solid 141260 111 and 61 patients with solid nodules 61508 1201 had nodal involvement Patients with nodal metastasis had a minimum solid size of 6 mm NSCLC with solid components 6 mm n1588 had no nodal metastasis Of them 339 patients underwent sublobar resection without lymphadenectomy SRN0 1056 subjects received sublobar resection with lymphadenectomy SRN1 and 190 patients received lobectomy plus lymphadenectomy LRN1 Patients with SRN0 had a shorter operating time less volume of drainage a lower incidence of chylothorax 0 vs 06 vs 21 P0012 and air leakage as well as a shorter postoperative hospitalization 3 vs 4 vs 4 days P0001 than those with SRN1 or LRN1 During a median follow-up of 61 months no patient with SRN0 was dead or tumor recurrent The 5-year recurrence-free survival was 100 992 and 985 for patients with SRN0 SRN1 and LRN1 respectively P0370
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None