Status:
RECRUITING
Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer
Lead Sponsor:
Hangzhou Broncus Medical Co., Ltd.
Collaborating Sponsors:
Shanghai Chest Hospital
Conditions:
Stage IA Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
This study is designed as a prospective, randomized controlled trial with 110 participants, randomized in a 1:1 ratio to CT-guided RFA and bronchoscopy-guided RFA groups. The primary study endpoint is...
Eligibility Criteria
Inclusion
- Age greater than 18 years.
- Primary peripheral lung cancer diagnosed by pathology, and preoperative staging reveals clinical stage T1N0M0, stage IA.
- The planned ablation lesions are assessed to be amenable to CT-guided and bronchoscopy-guided ablation.
- Assessed as inoperable or refused surgery, agree to undergo initial ablation therapy, and sign informed consent.
Exclusion
- Patients with platelet \< 50 × 10 9/L, severe bleeding tendency and coagulation dysfunction that cannot be corrected in a short period of time.
- Patients with severe pulmonary fibrosis and pulmonary hypertension.
- Perilesional infection and radiation inflammation, puncture site skin infection is not well controlled, systemic infection, high fever \> 38.5℃.
- 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.
- Patients with poorly controlled malignant pleural effusion.
- 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.
- Eastern Cooperative Oncology Group (ECOG) score \> 2.
- Combined with other tumors with extensive metastasis, expected survival \< 6 months.
- Patients with episodic psychosis.
- Patients with implantable electronic devices (such as pacemaker or defibrillator).
- Pregnant women, or patients who have pregnancy plans during the study.
- Participation or ongoing participation in another clinical study within the past 30 days.
- Other situations that the investigator deems inappropriate to participate in this study.
Key Trial Info
Start Date :
October 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06052098
Start Date
October 11 2023
End Date
October 1 2027
Last Update
December 6 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030