Transbronchial vs Transthoracic Ablation for Early-stage Peripheral Lung Cancer
NCT ID: NCT06052098
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2023-10-11
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Transbronchial group
Subjects receive bronchoscopy-guided RFA and undergo follow-up.
The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system
Procedure: In combination with guided bronchoscopy and CBCT, the ablation catheter is placed in the target lesion. CBCT confirms the tool in the lesion, adjusts the position of the ablation catheter, and monitors the extent of ablation.
Transthoracic group
Subjects receive CT-guided RFA and undergo follow-up.
The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system
Procedure: The ablation needle is punctured into the lesion under CT guidance. The extent of the ablation is monitored by CT.
Interventions
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The disposable pulmonary radiofrequency ablation catheter and pulmonary radiofrequency ablation system
Procedure: In combination with guided bronchoscopy and CBCT, the ablation catheter is placed in the target lesion. CBCT confirms the tool in the lesion, adjusts the position of the ablation catheter, and monitors the extent of ablation.
The disposable percutaneous radiofrequency ablation needle and pulmonary radiofrequency ablation system
Procedure: The ablation needle is punctured into the lesion under CT guidance. The extent of the ablation is monitored by CT.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Shanghai Chest Hospital
OTHER
Hangzhou Broncus Medical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jiayuan Sun, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Chest Hospital
Locations
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Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jiayuan Sun, MD, PhD
Role: primary
Other Identifiers
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BC-I-RF-01
Identifier Type: -
Identifier Source: org_study_id