Cryoablation vs Thoracoscopic Surgery for GGN

NCT ID: NCT06848881

Last Updated: 2025-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-15

Study Completion Date

2030-04-15

Brief Summary

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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.

Detailed Description

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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 was designed as a prospective, randomized controlled trial, with 160 patients expected to be enrolled in the study, randomized in a 1:1 ratio to cryoablation and thoracoscopic surgery treatment groups. 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.

Conditions

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Ground-Glass Opacity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cryoablation group

Ground-glass nodules were treated using cryoprobe by bronchoscope.

Group Type EXPERIMENTAL

Cryoablation

Intervention Type PROCEDURE

The eligible patient will be randomized to cryoablation group to receive cryoablation.

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).

Group Type ACTIVE_COMPARATOR

Thoracoscopic Surgery

Intervention Type PROCEDURE

The eligible patient will be randomized to thoracoscopic surgery group to receive surgery.

Interventions

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Cryoablation

The eligible patient will be randomized to cryoablation group to receive cryoablation.

Intervention Type PROCEDURE

Thoracoscopic Surgery

The eligible patient will be randomized to thoracoscopic surgery group to receive surgery.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients ≥ 18 years old.
2. The size of the GGN was 6-20mm (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 refuses 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 prior lung surgery or 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Chest Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jiayuan Sun

Director, Department of Respiratory Endoscopy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiayuan Sun, MD, PhD

Role: STUDY_DIRECTOR

Shanghai Chest Hospital

Locations

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Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Jiayuan Sun, MD, PhD

Role: CONTACT

+86-021-22200000 ext. 1511

Facility Contacts

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Jiayuan Sun, PhD

Role: primary

+86-021-22200000 ext. 1511

Other Identifiers

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SHCHE202501

Identifier Type: -

Identifier Source: org_study_id

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