A Single-center Study on the Effect of Systemic/Selective Lymph Node Dissection on the Prognosis of Ground Glass Nodules Smaller Than 3cm and With Components With Consolidation/Tumor Ratio Between 0.5-1

NCT ID: NCT05184829

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2029-12-31

Brief Summary

A single-center study on the effect of systemic/selective lymph node dissection on the prognosis of ground glass nodules smaller than 3cm and with components with consolidation/tumor ratio between 0.5-1

Detailed Description

A single-center study on the effect of systemic/selective lymph node dissection on the prognosis of ground glass nodules smaller than 3cm and with components with consolidation/tumor ratio between 0.5-1

Conditions

Progression; Postoperative Recovery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

systemic lymph node dissection group

systemic lymph node dissection group

Group Type: ACTIVE_COMPARATOR

Systemic Lymph Node Dissection

Intervention Type: OTHER

Systemic Lymph Node Dissection

selective lymph node dissection

selective lymph node dissection

Group Type: EXPERIMENTAL

selective lymph node dissection

Intervention Type: OTHER

selective lymph node dissection

Interventions

selective lymph node dissection

selective lymph node dissection

Intervention Type: OTHER

Systemic Lymph Node Dissection

Systemic Lymph Node Dissection

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Patients enrolled in the study must meet all of the following conditions:

• 1.Aged between 25 and 75 years;
• 2. GGO is diagnosed by thin-section lung CT (thickness <1.5mm) within one month before surgery;
• 3. The maximum diameter of the GGO is smaller than 3cm;
• 4. The solid component in GGO between 50%-100%;
• 5. Preoperative examination showed that the patient could tolerate lobectomy;
• 6. The patient is able to understand and comply with the study and has provided written informed consent.

Exclusion Criteria

Patients meeting any of the following criteria are not eligible for this trial:

• 1. Patients with a history of lung surgery;
• 2. Postoperative pathology showed non-primary lung cancer;
• 3. The scope of surgical resection is larger than one lung lobe;
• 4. Patients with a history of other tumors;
• 5. Patients with severe complications (coronary heart disease, valvular heart disease, end-stage renal disease, severe liver cirrhosis);
• 6. Unable to cooperate with the researchers because of dementia or cognitive decline
• 7. Other situations that are not in conformity with the standards and requirements of this trial.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

B2021

Identifier Type: -

Identifier Source: org_study_id