Clinical trial · Interventional
Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer
Transbronchial Versus Transthoracic Ablation for Early Stage Peripheral Lung Cancer: a Prospective, Randomized Controlled Trial
NCT06052098CI-TRIAL-00072033recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to investigate the efficacy and safety of RFA through a transthoracic or transbronchial approach in the treatment of early-stage peripheral lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IA Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system | Device | — | UNRESOLVED |
| The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Transbronchial group
- description
- Subjects receive bronchoscopy-guided RFA and undergo follow-up.
- interventionNames
- Device: The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system
- type
- EXPERIMENTAL
- label
- Transthoracic group
- description
- Subjects receive CT-guided RFA and undergo follow-up.
- interventionNames
- Device: The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system
Primary outcomes (1)
- measure
- Complete ablation rate at 6 months after ablation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age greater than 18 years. 2. Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA. 3. The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation. 4. Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent. Exclusion Criteria: 1. Patients with platelet \< 50 × 10 9/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time. 2. Patients with severe pulmonary fibrosis and pulmonary hypertension. 3. Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever \> 38.5℃. 4. Patients with severe liver, kidney, heart, lung and brain dysfunction, severe anemia, dehydration and severe nutritional metabolism disorders that cannot be corrected or improved in a short period of time. 5. Patients with poorly controlled malignant pleural effusion. 6. Anticoagulation therapy and/or antiplatelet agents (except novel oral anticoagulants such as dabigatran and rivaroxaban) are discontinued for less than 5\~7 days before ablation. 7. Eastern Cooperative Oncology Group (ECOG) score \> 2. 8. Combined with other tumors with extensive metastasis, expected survival \< 6 months. 9. Patients with episodic psychosis. 10. Patients with implantable electronic devices (such as pacemaker or defibrillator). 11. Pregnant women, or patients who have pregnancy plans during the study. 12. Participation or ongoing participation in another clinical study within the past 30 days. 13. Other situations that the investigator deems inappropriate to participate in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.