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Feasibility of lobe-specific lymph node dissection in early-stage non-small cell lung cancer: a prospective and randomized controlled study

Feasibility of lobe-specific lymph node dissection in early-stage non-small cell lung cancer: a prospective and randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048415
Enrollment
Unknown
Registered
2021-07-06
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small cell lung cancer

Interventions

Experimental group:Lobe-specific lymph node dissection
Control group:Systematic lymph node dissection

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years; 2. For patients whose preoperative blood pressure is controlled below 160/100mmHg, blood sugar is controlled at 5.6 - 11.2 mmol/L, and the functions of major organs such as heart, lung, liver, and kidney are normal, the main criteria are as follows: (1) Cardiac function test showed Goldman index grade 1-2; (2) Pulmonary function test showed that the predicted postoperative FEV1>=40%, and DLCO>=40%; (3) Total bilirubin = 60ml/min; 3. The first clinical diagnosis before surgery is non-small cell lung cancer, including adenocarcinoma, squamous cell carcinoma, large cell carcinoma and other unknown types of non-small cell lung cancer; 4. Thin-slice CT scans suggest peripheral tumors, the largest diameter of the tumor does not exceed 2cm, and CT images show non-solid nodules, the short diameter of mediastinal lymph nodes does not exceed 1cm, or PET/CT examination does not suggest mediastinal lymph node metastasis, the clinical stage is cT1a-1bN0 stage, namely cIa1-2 stage; 5. ECOG PS score 0-1; 6. All relevant inspections are completed within 28 days before surgery; 7. Patients who can understand this study and have signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who have received anti-tumor therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy) before surgery; 2. Patients with a history of other malignant tumors in the past; 3. Patients with second primary cancer at the time of enrollment; 4. Central lung cancer; 5. History of unilateral thoracotomy in the past; 6. Patients who are pregnant or breastfeeding; 7. Active bacterial or fungal infections that are difficult to control; 8. Severe mental illness; 9. A history of severe heart disease, heart failure, myocardial infarction or angina pectoris within the past 6 months.

Design outcomes

Primary

MeasureTime frame
5-year disease-free survival time;5 years overall survival time;

Secondary

MeasureTime frame
metastatic lymph node ratio;postoperative complication incidence and mortality (<=30 days);duration of operation;duration of anesthesia;volume of bleeding;volume of drainage;

Countries

China

Contacts

Public ContactDeng Hanyu

West China Hospital, Sichuan University

hanyudeng@scu.edu.cn+86 18200295920

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026