Clinical trial · Interventional
Transthoracic vs Transbronchial Cryoablation for Early-stage Peripheral Lung Cancer
Transthoracic Versus Transbronchial Cryoablation for Early-stage Peripheral Lung Cancer: A Prospective, Randomized Controlled Trial
NCT06572540CI-TRIAL-00092340recruitingN/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 study aims to compare the efficacy and safety of transthoracic cryoablation to transbronchial cryoablation 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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transbronchial cryoablation | Device | — | UNRESOLVED |
| Transthoracic cryoablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Transthoracic cryoablation
- description
- Subjects will undergo CT-guided cryoablation. According to the location of the lesion on the chest CT scan, the puncture point, direction of needle entry, and distance of needle entry will be determined. The primary cryoablation needle (via the chest wall) will be punctured into the lesion according to the pre-planed path, and the CT will confirm the correct position. One or more needles will rationally distributed in the lesion for ablation according to the morphology of the lesion.
- interventionNames
- Device: Transthoracic cryoablation
- type
- EXPERIMENTAL
- label
- Transbronchial cryoablation
- description
- Subjects will undergo bronchoscopically guided cryoablation. Appropriate guided bronchoscopic technique will be uesd. Cryoablation needle (flexible) will insert through the working channel of the bronchoscope to the target lesion, CBCT will be used to confirm the correct position and observe the ablation zone.
- interventionNames
- Device: Transbronchial cryoablation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age older than 18 years. 2. Primary peripheral lung cancer diagnosed by pathology and pre-procedure staging examination suggesting clinical stage T1N0M0, stage IA (including postoperative new and multiple primary). 3. The target lesion was evaluated to be feasible for both CT and bronchoscopy-guided ablation. 4. Patients who are not suitable for surgery or refuse surgery, agree to undergo initial ablation therapy and sign informed consent form. Exclusion Criteria: 1. Patients with platelets \<70×109/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short term. 2. Patients with severe pulmonary fibrosis and pulmonary arterial hypertension. 3. Infectious and radioactive inflammation around the lesion, skin infection at the puncture site that is not well controlled, systemic infection, high fever \>38.5°C. 4. Patients with severe hepatic, renal, cardiac, pulmonary and cerebral insufficiency, severe anaemia, dehydration and serious disorders of nutritional metabolism that cannot be corrected or improved in a short term. 5. Those with poorly controlled malignant pleural effusions. 6. Anticoagulation therapy and/or anti-platelet drugs (except dabigatran, rivaroxaban and other new oral anticoagulants) have not been discontinued more than 5\~7d before ablation. 7. Eastern Cooperative Oncology Group (ECOG) score \>2. 8. Combination with other tumors with extensive metastases and an expected survival of \<6 months. 9. Patients with episodic psychosis. 10. Pregnant women, or patients with pregnancy plan during the study period. 11. Have participated or are participating in other clinical studies within 30 days. 12. Any other condition that the investigator considers inappropriate for participation in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.