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| ID | Type | Description | Link |
|---|---|---|---|
| nanosecond knife01 | Registry Identifier | nanosecond knife tumor ablation for liver cancer |
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| Name | Class |
|---|---|
| Shulan (Hangzhou) Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
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This is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.
The prospective, multi-center, single-arm clinical trial is to evaluate whether the nanosecond knife can achieve the effectiveness and safety of liver cancer ablation treatment. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. This clinical trial requires 190 subjects. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary outcome (the effective rate of nanosecond knife ablation for liver cancer) and secondary outcomes (partial response rate, secondary ablation rate, progression-free survival, overall survival rate, quality of life score, alpha-fetoprotein levels, technical success rate, local control rate, complication rate, device Use satisfaction of nanosecond knife ablation for liver cancer). The first 2-month follow-up after the operation, CT, MR, CEUS, liver function, tumor markers were reviewed monthly to observe the lesion necrosis and tumor marker changes. After that, tumor markers, CEUS, or three-phase CT/MRI of liver were examined every 2 to 3 months. After two years, tumor markers, CEUS, or three-phase CT/MRI of liver were examined every 3 to 6 months. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nanosecond knife group | Experimental | This trial is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nanosecond knife liver cancer ablation | Procedure | This trial is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness analysis | The effective rate of nanosecond knife ablation for liver cancer | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary validity analysis | partial response rate of nanosecond knife ablation for liver cancer | 12 months |
| Secondary validity analysis | secondary ablation rate of nanosecond knife ablation for liver cancer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tian'an Jiang, PhD | Contact | 18857127666 | tiananjiang@zju.edu.cn |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18477802 | Background | Llovet JM, Di Bisceglie AM, Bruix J, Kramer BS, Lencioni R, Zhu AX, Sherman M, Schwartz M, Lotze M, Talwalkar J, Gores GJ; Panel of Experts in HCC-Design Clinical Trials. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst. 2008 May 21;100(10):698-711. doi: 10.1093/jnci/djn134. Epub 2008 May 13. | |
| 21128329 |
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This trial is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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To evaluate whether the nanosecond knife can achieve the effectiveness and safety of liver cancer ablation treatment.
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| 12 months |
| Secondary validity analysis | progression-free survival of nanosecond knife ablation for liver cancer | 12 months |
| Secondary validity analysis | overall survival rate of nanosecond knife ablation for liver cancer | 12 months |
| Secondary validity analysis | quality of life score of nanosecond knife ablation for liver cancer | 12 months |
| Secondary validity analysis | alpha-fetoprotein levels | 12 months |
| Secondary validity analysis | technical success rate of nanosecond knife ablation for liver cancer | 12 months |
| Secondary validity analysis | local control rate of nanosecond knife ablation for liver cancer | 12 months |
| Secondary validity analysis | complication rate of nanosecond knife ablation for liver cancer | 12 months |
| Secondary validity analysis | device Use satisfaction of nanosecond knife ablation for liver cancer | 12 months |
| Gu YK, Luo RG, Huang JH, Si Tu QJ, Li XX, Gao F. Transarterial embolization ablation of hepatocellular carcinoma with a lipiodol-ethanol mixture. World J Gastroenterol. 2010 Dec 7;16(45):5766-72. doi: 10.3748/wjg.v16.i45.5766. |
| 20308465 | Background | Bargellini I, Vignali C, Cioni R, Petruzzi P, Cicorelli A, Campani D, De Simone P, Filipponi F, Bartolozzi C. Hepatocellular carcinoma: CT for tumor response after transarterial chemoembolization in patients exceeding Milan criteria--selection parameter for liver transplantation. Radiology. 2010 Apr;255(1):289-300. doi: 10.1148/radiol.09090927. |
| 28109674 | Background | Fruhling P, Nilsson A, Duraj F, Haglund U, Noren A. Single-center nonrandomized clinical trial to assess the safety and efficacy of irreversible electroporation (IRE) ablation of liver tumors in humans: Short to mid-term results. Eur J Surg Oncol. 2017 Apr;43(4):751-757. doi: 10.1016/j.ejso.2016.12.004. Epub 2017 Jan 11. |
| 28799842 | Background | Distelmaier M, Barabasch A, Heil P, Kraemer NA, Isfort P, Keil S, Kuhl CK, Bruners P. Midterm Safety and Efficacy of Irreversible Electroporation of Malignant Liver Tumors Located Close to Major Portal or Hepatic Veins. Radiology. 2017 Dec;285(3):1023-1031. doi: 10.1148/radiol.2017161561. Epub 2017 Aug 11. |
| 11592607 | Background | Bruix J, Sherman M, Llovet JM, Beaugrand M, Lencioni R, Burroughs AK, Christensen E, Pagliaro L, Colombo M, Rodes J; EASL Panel of Experts on HCC. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. European Association for the Study of the Liver. J Hepatol. 2001 Sep;35(3):421-30. doi: 10.1016/s0168-8278(01)00130-1. No abstract available. |
| 36587393 | Derived | Liu J, Fang C, Jin X, Tian G, Sun Z, Hong L, Pan J, Chen X, Zhao J, Cao H, Jiang T. Nanosecond pulsed electric field ablation-induced modulation of sphingolipid metabolism is associated with Ly6c2+ mononuclear phagocyte differentiation in liver cancer. Mol Oncol. 2023 Jun;17(6):1093-1111. doi: 10.1002/1878-0261.13372. Epub 2023 Jan 21. |
| 35912221 | Derived | Xu M, Xu D, Dong G, Ren Z, Zhang W, Aji T, Zhao Q, Chen X, Jiang T. The Safety and Efficacy of Nanosecond Pulsed Electric Field in Patients With Hepatocellular Carcinoma: A Prospective Phase 1 Clinical Study Protocol. Front Oncol. 2022 Jul 13;12:869316. doi: 10.3389/fonc.2022.869316. eCollection 2022. |
| D008107 |
| Liver Diseases |