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Efficacy of Surgery Combined with Ablation versus Sequential Surgery for Bilateral, Synchronous, Multiple Subsolid Pulmonary Nodules: A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Trial

Efficacy of Surgery Combined with Ablation versus Sequential Surgery for Bilateral, Synchronous, Multiple Subsolid Pulmonary Nodules: A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108182
Enrollment
Unknown
Registered
2025-08-26
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with bilateral, synchronous, multiple subsolid pulmonary nodules (suspected multifocal primary lung cancers)

Interventions

Control group:Sequential surgical treatment
Experimental group:Surgery combined with ablation therapy

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Presence of bilateral multiple subsolid pulmonary nodules requiring intervention: Based on imaging and/or percutaneous biopsy, a multidisciplinary team (MDT) concludes that the patient has synchronous malignant or suspicious malignant subsolid nodules in both lungs, necessitating regional treatment for lesions on both sides. The maximum nodule diameter and the consolidation-to-tumor ratio (CTR) are used as the primary criteria to designate dominant and secondary lesions during MDT review. 2. Dominant subsolid lesion: maximum diameter 8 mm = 80 % of predicted value and FEV1/FVC>= 80 %. 7. Written informed consent obtained from the patient to participate in this study.

Exclusion criteria

Exclusion criteria: 1.Solid malignant or suspicious malignant pulmonary nodules, or space-occupying lesions > 2 cm in maximum diameter. 2.Contralateral secondary lesions deemed unsuitable for sublobar resection or ablation. 3.Evidence of regional lymph-node or distant metastasis on pre-operative evaluation. 4. Suspected primary lung cancer with intrapulmonary metastasis. 5. Prior anti-tumor therapy (chemotherapy, radiotherapy, immunotherapy, targeted therapy, etc.). 6. Comorbid interstitial pneumonia, acute pulmonary infection, or pulmonary fibrosis. 7. Uncontrolled systemic diseases: refractory infection, severe cardiovascular/cerebrovascular disease, hepatic or renal dysfunction, diabetes mellitus, or other metabolic disorders. 8. History of prior malignancy. 9. Trauma or surgery within the preceding 6 months. 10. Pregnancy, planned pregnancy, or lactation. 11. Psychiatric or psychological disorders. 12. Any other condition considered by the investigators as unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Post-operative quality of life (QoL);5-year overall survival (OS) and overall survival time;

Secondary

MeasureTime frame
Tumor response to ablation;Treatment-related complications;

Countries

China

Contacts

Public ContactXiangnan Li

The First Affiliated Hospital of Zhengzhou University

lxn-2000@163.com+86 13592502553

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026