Cryoablation vs Thoracoscopic Surgery for GGN

Cryoablation Versus Thoracoscopic Surgery for Pulmonary Ground-Glass Nodules: A Prospective, Comparative, Open Label Study

The aim of this study is to investigate the efficacy and safety of Cryoablation and Thoracoscopic Surgery in the treatment of pulmonary ground-glass nodules.

Study Overview

• Status: Recruiting
• Conditions: Ground-Glass Opacity
• Intervention / Treatment: Procedure: Cryoablation; Procedure: Thoracoscopic Surgery

Detailed Description

The primary treatment for GGN type lung cancer is surgical resection, typically using video-assisted thoracoscopic surgery (VATS). Image-guided ablation therapy is considered as a treatment option for early-stage lung cancer patients unsuitable for surgery. It has been recommended by several guidelines as one of the curative treatment methods for primary lung cancer. Among various ablation techniques, cryoablation has the lowest complication rate. However, there is currently no research exploring whether cryoablation is not inferior to thoracoscopic surgery in terms of safety and efficacy in treating highly suspected malignant lung GGNs. This study is designed as a prospective, non-randomized study, with 160 patients expected to be enrolled, who will be assigned to cryoablation or video-assisted thoracoscopic surgery treatment groups based on patient preference. The primary endpoint is the 2-year disease-free survival. Secondary endpoints include 1-month mortality rate, overall survival, 5-year disease-free survival, local recurrence rate, VATS/ cryoablation completion rate, safety, etc.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiayuan Sun, MD, PhD; Phone Number: 1511 +86-021-22200000; Email: xkyyjysun@163.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Recruiting
      • Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: Jiayuan Sun, PhD; Phone Number: 1511 +86-021-22200000; Email: jysun1976@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients ≥ 18 years old.
2. The size of the GGN is 8-20mm (with less than 25% solid component), and the number of nodules requiring treatment in the short term is less than 3.
3. Pathological confirmation of the GGN as non-small cell lung cancer; or progression of the GGN during at least 3 months of follow-up, including enlargement of the largest diameter, increase in solid component, or the appearance of a significant solid component in a previously pure GGN, with multidisciplinary discussion (including radiology, thoracic surgery, and pulmonology) suggesting malignancy.
4. No lymph node, pulmonary, or distant metastasis to other organs.
5. After multidisciplinary evaluation, the patient is considered capable of tolerating both surgical and ablation procedures.
6. Unsuitable for radiation therapy or refusal of radiation therapy.
7. Willing to participate in this clinical study and sign the informed consent form.

Exclusion Criteria:

1. Patients in poor general condition, with ECOG physical fitness score >2, unable to tolerate surgery or ablation therapy, or with relevant contraindications.
2. Patients who have previously received other treatments for pulmonary GGNs.
3. Patients with poor compliance.
4. Severe heart, lung, kidney, brain, or other vital organ diseases.
5. Active bacterial or fungal infections.
6. Simultaneous or metachronous (within the past 5 years) double cancers.
7. Women during pregnancy or breast-feeding.
8. History of radiation therapy.
9. Bleeding tendency, abnormal coagulation functions, or coagulation disorders that cannot be corrected after treatment.
10. Contraindications to general anesthesia.
11. Expected survival time < 6 months.
12. The researcher believes that it is not suitable for inclusion.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Thoracoscopic Surgery group; Ground-glass nodules were treated by video-assisted thoracoscopic surgery (VATS). Based on the location of the GGN, select the appropriate surgical resection range (wedge resection, segmentectomy, lobectomy, or combined segmentectomy).	Procedure: Thoracoscopic Surgery; The eligible patient will be voluntarily assigned to thoracoscopic surgery group and receive surgery.
Experimental: Cryoablation group; Ground-glass nodules were treated using cryoprobe by transbronchial or percutaneous method.	Procedure: Cryoablation; The eligible patient will be voluntarily assigned to the cryoablation group and receive cryoablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year disease-free survival	Defined as the time from enrollment to the occurrence of disease recurrence, the discovery of new lesions, or death due to any cause.	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-month mortality rate	The proportion of patients who die within one month after treatment.	1 month after the treatment
Overall survival	Defined as the time from enrollment to death from any cause, or to the last contact with surviving patients.	Up to 2 years, 5years
5-year disease-free survival	Defined as the time from enrollment to the occurrence of disease recurrence, the discovery of new lesions, or death due to any cause.	Up to 5 years
Local recurrence rate	The proportion of patients who experience disease recurrence at the original treatment site.	Up to 5 years
VATS/ cryoablation completion rate	The proportion of patients in whom VATS or cryoablation is successfully completed.	immediately after the treatment
Forced Expiratory Volume in 1 Second (FEV1)	The maximum volume of air exhaled in the first second during a forced expiration following maximal inhalation.	3 months after the treatment
Forced Vital Capacity (FVC)	The total volume of air exhaled as forcefully and completely as possible after maximal inhalation.	3 months after the treatment
Adverse events and serious adverse events	Complications at 3 months after the treatment will be assessed using the Clavien-Dindo classification of surgical complications. Aderse events will be evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	3 months after the treatment
Quality of life assessment	Pain scores.	1 week after the treatment
Length of hospital stay	The duration of hospital stay after treatment.	1 month after the treatment

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Investigators: Study Director: Jiayuan Sun, MD, PhD, Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2025
• Primary Completion (Estimated): April 15, 2030
• Study Completion (Estimated): April 15, 2030

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 22, 2025
• First Posted (Actual): February 27, 2025

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Diagnostic Techniques, Surgical; Endoscopy; Thoracic Surgical Procedures; Ablation Techniques; Cryosurgery; Thoracoscopy
• Other Study ID Numbers: SHCHE202501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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