Transthoracic vs Transbronchial Radiofrequency Ablation for Lung Cancer

Transthoracic Versus Transbronchial Radiofrequency Ablation for Peripheral Lung Cancer Staging IA: a Prospective, Randomized Controlled Trial

The aim of this study is to investigate the efficacy and safety of transthoracic versus transbronchial ablation in the treatment of early stage peripheral lung cancer.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer Stage IA
• Intervention / Treatment: Procedure: ablation

Detailed Description

Ablation therapy has been widely used in the treatment of lung cancer and traditionally performed by CT-guided transthoracic puncture. In recent years, with the development of navigational bronchoscopy, exploratory studies on transbronchial ablation for peripheral lung cancer have demonstrated its efficacy and safety, but there is a lack of prospective randomized controlled trials to verify its near-term efficacy and safety, as well as its long-term efficacy. This study was designed as a prospective randomised controlled trial with 110 patients expected to participate in the study, randomized in a 1:1 ratio to CT-guided ablation and bronchoscopy-guided ablation treatment groups. The primary study endpoint is the rate of complete ablation at 6 months post-procedure. Secondary study endpoints were success rate of technique implementation, complete ablation rate at 12 months post-procedure, local control rate at 1, 2 and 3 years post-procedure, progression-free survival, overall survival and safety.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiayuan Sun, PhD; Phone Number: 1511 +86-021-22200000; Email: jysun1976@163.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Jiayuan Sun, PhD; Phone Number: 1511 +86-021-22200000; Email: jysun1976@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age greater 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 proposed ablation lesion was evaluated for feasibility of CT and bronchoscopy-guided ablation treatment.
4. Consent to initial ablation therapy is given after assessment of unsuitability for surgery or refusal of surgery and signed informed consent form.

Exclusion Criteria:

1. Patients with platelets <50×109/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in the 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 the 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 of other tumours with extensive metastases and an expected survival of <6 months.
9. Patients with episodic psychosis.
10. Patients with implanted electronic devices (e.g. pacemakers or defibrillators).
11. Pregnant women, or patients with a pregnancy planned during the study period.
12. Have participated or are participating in other clinical studies within the last 30 days.
13. Any other condition that the investigator considers inappropriate for participation in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transthoracic ablation	Procedure: ablation; ablation
Experimental: Transbronchial ablation	Procedure: ablation; ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete ablation rate at 6 months post-procedure	This refers to the number of lesions completely ablated 6 months after ablative treatment as a proportion of the total number of ablative treated lesions.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of technique implementation	Defined as the number of lesions reached by the ablation needle and successfully treated by ablation as a proportion of the total number of lesions to be ablated, as assessed by imaging immediately after ablation.	Immediate postoperative
Complete ablation rate at 12 months post-procedure	This refers to the number of lesions completely ablated 12 months after ablative treatment as a proportion of the total number of ablative treated lesions.	Up to 12 months
Local control rate at 1, 2 and 3 years post-procedure	This refers to the number of completely ablated and incompletely ablated lesions at 1, 2 and 3 years after ablative treatment as a proportion of the total number of ablative treated lesions.	Up to 36 months
Progression-free survival	Refers to the duration between the subject's study procedure and the first occurrence of disease progression or death from any cause, recorded through follow-up for up to 3 years.	Up to 36 months
Overall survival	Refers to the duration between the subject's study procedure and the subject's death, recorded through follow-up for up to 3 years.	Up to 36 months
Incidence of complications	Assessment of the incidence of device or procedure-related adverse events that occurred during the study.	Up to 6 months

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Collaborators: Beijing Chao Yang Hospital; Sir Run Run Shaw Hospital
• Investigators: Study Director: Jiayuan Sun, PhD, Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: SHCHE202301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No