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

NCT04581122 | Recruiting

• 1 other identifier: B2020-164R
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• overall survival (OS)

  five year overall survival

  5 years

Study Arms (2)

Selective lymphadenectomy

EXPERIMENTAL

Procedure: Lymphadenectomy

Systematic lymph node dissection

NO INTERVENTION

Interventions

Lymphadenectomy 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

Selective lymphadenectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 75 years;
• GGO is diagnosed by lung CT and failure to subside after 3 months (the patient having been re-examined by thin-section CT);
• The maximum diameter of the GGO is smaller than 3cm;
• The maximum diameter of the solid component in the GGO is more than 50%;
• The patient is able to undergo the lobectomy
• The patient is able to understand and comply with the study and has provided written informed consent.

You may not qualify if:

• Patients meeting any of the following criteria are not eligible for this trial:
• Patients with a history of using immunosuppressive or hormonal drugs;
• Patients receiving radiotherapy or chemotherapy;
• Patients who fail to comply with our follow-up strategy;
• Other situations that are not in conformity with the standards and requirements of this trial.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Jiang Wei

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Disease Progression

Interventions

Lymph Node Excision

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Jiang Wei

  Fudan University

  STUDY DIRECTOR

Central Study Contacts

Jiang Wei, Dr

CONTACT

86-21-64041990; jiang.wei1@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2020
• First Posted: October 9, 2020
• Study Start: September 1, 2020
• Primary Completion: December 31, 2022
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 9, 2020

Record last verified: 2020-10

Locations

CN (1)