Transthoracic vs Transbronchial Cryoablation for Early-stage Peripheral Lung Cancer
NCT ID: NCT06572540
Last Updated: 2025-07-18
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
2024-09-01
2028-12-31
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
SINGLE
Study Groups
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Transthoracic cryoablation
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.
Transthoracic cryoablation
Transthoracic cryoablation will be performed under the guidance of CT.
Transbronchial cryoablation
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.
Transbronchial cryoablation
Transbronchial cryoablation will be performed under the guidance of navigation bronchoscopy and CBCT.
Interventions
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Transthoracic cryoablation
Transthoracic cryoablation will be performed under the guidance of CT.
Transbronchial cryoablation
Transbronchial cryoablation will be performed under the guidance of navigation bronchoscopy and CBCT.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Jiayuan Sun
OTHER
Responsible Party
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Jiayuan Sun
Director, Department of Respiratory Endoscopy
Principal Investigators
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Jiayuan Sun, PhD
Role: STUDY_DIRECTOR
Shanghai Chest Hospital
Locations
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The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital , affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Shiyue Li, PhD
Role: primary
Xiaoju Zhang, PhD
Role: primary
Dan Liu, PhD
Role: primary
Enguo Chen, PhD
Role: primary
Other Identifiers
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AT-RXLD-202401
Identifier Type: -
Identifier Source: org_study_id
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