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

NCT05184829 | Not Yet Recruiting DMC

• 1 other identifier: B2021
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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

Conditions

Progression; Postoperative Recovery

Outcome Measures

Primary Outcomes (1)

• Overall survival

  From enrollment to 36 months after surgery

Secondary Outcomes (1)

• Complications

  1-2 Weeks after enrollment (after Surgery)

Study Arms (2)

systemic lymph node dissection group

ACTIVE COMPARATOR

systemic lymph node dissection group

Other: Systemic Lymph Node Dissection

selective lymph node dissection

EXPERIMENTAL

selective lymph node dissection

Other: selective lymph node dissection

Interventions

selective lymph node dissection OTHER

selective lymph node dissection

selective lymph node dissection

Systemic Lymph Node Dissection OTHER

Systemic Lymph Node Dissection

systemic lymph node dissection group

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients enrolled in the study must meet all of the following conditions:
• Aged between 25 and 75 years;
• \. GGO is diagnosed by thin-section lung CT (thickness \<1.5mm) within one month before surgery;
• \. The maximum diameter of the GGO is smaller than 3cm;
• \. The solid component in GGO between 50%-100%;
• \. Preoperative examination showed that the patient could tolerate 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 lung surgery;
• \. Postoperative pathology showed non-primary lung cancer;
• \. The scope of surgical resection is larger than one lung lobe;
• \. Patients with a history of other tumors;
• \. Patients with severe complications (coronary heart disease, valvular heart disease, end-stage renal disease, severe liver cirrhosis);
• \. Unable to cooperate with the researchers because of dementia or cognitive decline
• \. Other situations that are not in conformity with the standards and requirements of this trial.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Disease Progression

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open label
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: systemic or selective lymph node dissection group

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 11, 2022
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 11, 2022

Record last verified: 2021-12