Omitting of Lymphadenectomy is Acceptable for Lung Cancer Smaller Than 6 mm in Solid Size

NCT ID: NCT06516796

Last Updated: 2024-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2713 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-02-01

Brief Summary

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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.

Detailed Description

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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 (2.76%) had nodal involvement. None of patients with pure ground glass opacity (0/945) had nodal metastasis, while 14 patients with part-solid (14/1260, 1.11%) and 61 patients with solid nodules (61/508, 12.01%) had nodal involvement. Patients with nodal metastasis had a minimum solid size of 6 mm. NSCLC with solid components \< 6 mm (n=1588) 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. 0.6% vs. 2.1%, P=0.012) and air leakage, as well as a shorter postoperative hospitalization (3 vs. 4 vs. 4 days, P\<0.001) 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%, 99.2% and 98.5% for patients with SRN0, SRN1 and LRN1, respectively (P=0.370).

Conditions

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Non-small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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sublobar resection without lymphadenectomy

Patients received sublobar resection but had no lymphadenectomy

No intervention

Intervention Type OTHER

Patients were retrospectively screened.

sublobar resection with lymphadenectomy

Patients received sublobar resection plus lymphadenectomy

No intervention

Intervention Type OTHER

Patients were retrospectively screened.

lobectomy plus lymphadenectomy

Patients received lobectomy plus lymphadenectomy

No intervention

Intervention Type OTHER

Patients were retrospectively screened.

Interventions

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No intervention

Patients were retrospectively screened.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* pathologically confirmed non-small cell lung cancer (NSCLC)
* the maximum tumor diameter ≤2 cm
* receiving surgical treatment between 2009-2022

Exclusion Criteria

* non-primary NSCLC;
* with small cell lung cancer components;
* undergoing preoperative neoadjuvant therapies;
* with compromised resection;
* malignant tumor history over the past five years.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Liang Chen

OTHER

Sponsor Role lead

Responsible Party

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Liang Chen

Director, Head of Thoracic Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Liang Chen, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

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Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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2022-SR-760

Identifier Type: -

Identifier Source: org_study_id

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