Cryoablation vs Thoracoscopic Surgery for GGN

NCT06848881 | Recruiting DMC

• 1 other identifier: SHCHE202501
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ground-Glass Opacity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 1-month mortality rate

  1 month after the treatment

• Overall survival

  Up to 2 years, 5years

• 5-year disease-free survival

  Up to 5 years

• Local recurrence rate

  Up to 5 years

• VATS/ cryoablation completion rate

  immediately after the treatment

Study Arms (2)

Cryoablation group

EXPERIMENTAL

Ground-glass nodules were treated using cryoprobe by transbronchial or percutaneous method.

Procedure: Cryoablation

Thoracoscopic Surgery group

ACTIVE COMPARATOR

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

Interventions

Cryoablation PROCEDURE

The eligible patient will be voluntarily assigned to the cryoablation group and receive cryoablation.

Cryoablation group

Thoracoscopic Surgery PROCEDURE

The eligible patient will be voluntarily assigned to thoracoscopic surgery group and receive surgery.

Thoracoscopic Surgery group

Eligibility Criteria

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

You may qualify if:

• Patients ≥ 18 years old.
• 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.
• 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.
• No lymph node, pulmonary, or distant metastasis to other organs.
• After multidisciplinary evaluation, the patient is considered capable of tolerating both surgical and ablation procedures.
• Unsuitable for radiation therapy or refusal of radiation therapy.
• Willing to participate in this clinical study and sign the informed consent form.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Interventions

Cryosurgery; Thoracoscopy

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Jiayuan Sun, MD, PhD

  Shanghai Chest Hospital

  STUDY DIRECTOR

Central Study Contacts

Jiayuan Sun, MD, PhD

CONTACT

+86-021-22200000; xkyyjysun@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Respiratory Endoscopy

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 27, 2025
• Study Start: April 20, 2025
• Primary Completion (Estimated): April 15, 2030
• Study Completion (Estimated): April 15, 2030
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)