Ground-Glass OpacityNCT06848881
Cryoablation vs Thoracoscopic Surgery for GGN
A study testing Cryoablation and Thoracoscopic Surgery in people with Ground-Glass Opacity, run by Shanghai Chest Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ground-Glass Opacity
- What is being tested?
- Cryoablation and Thoracoscopic Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2025to 15 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- The researcher believes that it is not suitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Jiayuan Sun, PhD, +86-021-22200000 ext. 1511, jysun1976@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Ground-Glass Opacity
- Being tested
- Cryoablation, Thoracoscopic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationProcedure or surgery
The eligible patient will be voluntarily assigned to the cryoablation group and receive cryoablation.
Thoracoscopic SurgeryProcedure or surgery
The eligible patient will be voluntarily assigned to thoracoscopic surgery group and receive surgery.
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation group | Experimental | Ground-glass nodules were treated using cryoprobe by transbronchial or percutaneous method. Receives: 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). Receives: Procedure: Thoracoscopic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (10)
1-month mortality rate
The proportion of patients who die within one month after treatment.
Measured: 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.
Measured: 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.
Measured: Up to 5 years
Local recurrence rate
The proportion of patients who experience disease recurrence at the original treatment site.
Measured: Up to 5 years
VATS/ cryoablation completion rate
The proportion of patients in whom VATS or cryoablation is successfully completed.
Measured: 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.
Measured: 3 months after the treatment
Forced Vital Capacity (FVC)
The total volume of air exhaled as forcefully and completely as possible after maximal inhalation.
Measured: 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.
Measured: 3 months after the treatment
Quality of life assessment
Pain scores.
Measured: 1 week after the treatment
Length of hospital stay
The duration of hospital stay after treatment.
Measured: 1 month after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start20 Apr 2025
- Primary completion15 Apr 2030 (estimated)
- Study completion15 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ground-Glass OpacityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
- Investigators
- Jiayuan Sun, MD, PhD, Study director, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06848881
- Sponsor's protocol ID
- SHCHE202501
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoablation Versus Thoracoscopic Surgery for Pulmonary Ground-Glass Nodules: A Prospective, Comparative, Open Label Study
- ClinicalTrials.gov ID
- NCT06848881
- Acronym / sponsor ID
- SHCHE202501
- Conditions
- Ground-Glass Opacity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 15 Apr 2030 (estimated)
- Study completion
- 15 Apr 2030 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoablation group | Experimental | Procedure: CryoablationGround-glass nodules were treated using cryoprobe by transbronchial or percutaneous method. |
| Thoracoscopic Surgery group | Active comparator | Procedure: Thoracoscopic SurgeryGround-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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoablationThe eligible patient will be voluntarily assigned to the cryoablation group and receive cryoablation. | Procedure or surgery | Cryoablation group |
| Thoracoscopic SurgeryThe eligible patient will be voluntarily assigned to thoracoscopic surgery group and receive surgery. | Procedure or surgery | Thoracoscopic Surgery group |
Primary outcome
2-year disease-free survival
Time frame: Up to 2 years
Defined as the time from enrollment to the occurrence of disease recurrence, the discovery of new lesions, or death due to any cause.
10 secondary outcomes
1-month mortality rate
Time frame: 1 month after the treatment
Overall survival
Time frame: Up to 2 years, 5years
5-year disease-free survival
Time frame: Up to 5 years
Local recurrence rate
Time frame: Up to 5 years
VATS/ cryoablation completion rate
Time frame: immediately after the treatment
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: 3 months after the treatment
Forced Vital Capacity (FVC)
Time frame: 3 months after the treatment
Adverse events and serious adverse events
Time frame: 3 months after the treatment
Quality of life assessment
Time frame: 1 week after the treatment
Length of hospital stay
Time frame: 1 month after the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiayuan Sun, MD, PhD study director
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation and Thoracoscopic Surgery in people with Ground-Glass Opacity, run by Shanghai Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiayuan Sun, MD, PhD (+86-021-22200000 ext. 1511, xkyyjysun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year disease-free survival (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.