NCT06572540

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Jiayuan Sun · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study aims to compare the efficacy and safety of transthoracic cryoablation to transbronchial cryoablation in the treatment of early-stage peripheral lung cancer.

Detailed description

Ablation therapy has been widely used in the treatment of peripheral lung cancer. Among various ablation techniques, cryoablation has been demonstrated to be therapeutic efficacy with several advantages, including high safety, clear ablation borders, and minimal local pain. With the development of navigational bronchoscopy, pilot study on transbronchial cryoablation for peripheral lung cancer has proved its efficacy and safety, but there is a lack of prospective randomized controlled trials to verify its near-term as well as long-term efficacy and safety. This study was designed as a prospective, randomized controlled, multicenter clinical trial. A total of 110 participants will be randomly assigned to either the transbronchial group or the transthoracic group in a 1:1 ratio. The primary endpoint is the complete ablation rate at 12 months post-ablation. Secondary endpoints include technical success rate, complete ablation rate at 6 months post-ablation, local control rate at 1, 2 and 3 years post-ablation, progression-free survival, overall survival, and safety.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DEVICE	Transthoracic cryoablation	Transthoracic cryoablation will be performed under the guidance of CT.
DEVICE	Transbronchial cryoablation	Transbronchial cryoablation will be performed under the guidance of navigation bronchoscopy and CBCT.

Timeline

• Start date: 2024-09-01
• Primary completion: 2025-12-31
• Completion: 2028-12-31
• First posted: 2024-08-27
• Last updated: 2025-07-18

Locations

5 sites across 1 country: China