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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Progression; Postoperative Recovery
• Intervention / Treatment: Other: Systemic Lymph Node Dissection; Other: selective lymph node dissection

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

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: systemic lymph node dissection group	Other: Systemic Lymph Node Dissection; Systemic Lymph Node Dissection
Experimental: selective lymph node dissection	Other: selective lymph node dissection; selective lymph node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	From enrollment to 36 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	The degrees of cough	1-2 Weeks after enrollment (after Surgery)

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): December 31, 2028
• Study Completion (Anticipated): December 31, 2029

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: December 28, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression
• Other Study ID Numbers: B2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No