A Multiple-center Study on the Effect of Different Ways of Lymph Node Dissection on the Prognosis of Ground Glass Nodules Smaller Than 3cm and With More Than 50% Solid Components

NCT ID: NCT04581122

Last Updated: 2020-10-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2028-12-31

Brief Summary

A multiple-center study on the effect of different ways of lymph node dissection on the prognosis of less than 3cm ground glass nodules with more than solid components

Conditions

Progression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Selective lymphadenectomy

Group Type: EXPERIMENTAL

Lymphadenectomy

Intervention Type: PROCEDURE

Patients with ground glass nodules smaller than 3cm and with more than 50%solid components would randomly assigned to selective lymphadenectomy group or systematic lymph node dissection group

Systematic lymph node dissection

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lymphadenectomy

Patients with ground glass nodules smaller than 3cm and with more than 50%solid components would randomly assigned to selective lymphadenectomy group or systematic lymph node dissection group

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Aged between 18 and 75 years;

2. GGO is diagnosed by lung CT and failure to subside after 3 months (the patient having been re-examined by thin-section CT);

3. The maximum diameter of the GGO is smaller than 3cm;

4. The maximum diameter of the solid component in the GGO is more than 50%;

5. The patient is able to undergo the 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 using immunosuppressive or hormonal drugs;

2. Patients receiving radiotherapy or chemotherapy;

3. Patients who fail to comply with our follow-up strategy;

4. Other situations that are not in conformity with the standards and requirements of this trial.

• Minimum Eligible Age: 18 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

Principal Investigators

Jiang Wei

Role: STUDY_DIRECTOR

Fudan University

Locations

Jiang Wei

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiang Wei, Dr

Role: CONTACT

jiang.wei1@zs-hospital.sh.cn

86-21-64041990 ext. 86-21-64041990

Facility Contacts

Jiang Wei

Role: primary

jiang.wei1@zs-hospital.sh.cn

Other Identifiers

B2020-164R

Identifier Type: -

Identifier Source: org_study_id