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| Name | Class |
|---|---|
| Zhejiang Cancer Hospital | OTHER |
| West China Hospital | OTHER |
| Tianjin Third Central Hospital | OTHER |
| Third Affiliated Hospital, Sun Yat-Sen University |
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This clinical trial is a multicenter, randomized, parallel-controlled study. In this study, patients with liver cancer were selected as the research subjects, and the subjects were randomly divided into the experimental group and the control group. The experimental group used the steep pulse treatment system produced by Zhejiang CuraWay Medical Technology Co., Ltd., and the control group used the RF Ablation System produced by Covidien llc. A total of 5 or 9 visits were planned in this study, namely the screening period (-14-0 days), the day of the first ablation, 2 ± 1 days after the first ablation, 30 ± 5 days after the first ablation, and after the first ablation 90±7 days, the day of secondary ablation, 2±1 days after secondary ablation, 30±5 days after secondary ablation, and 90±7 days after secondary ablation. The complete ablation rate at 30 ± 5 days after the first ablation was used as the main efficacy evaluation index to evaluate the safety and efficacy of the steep pulse therapy system produced by Zhejiang CuraWay Medical Technology Co., Ltd. for liver tumor ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steep Pulse Therapy System | Experimental |
| |
| RF Ablation System | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| steep pulse therapy system | Device | The steep pulse therapy system is produced by Zhejiang CuraWay Medical Technology Co., Ltd. for liver tumor ablation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30-day complete ablation rate | Complete ablation rate | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total complete ablation rate | 90 days | |
| Success rate of puncture | 1 day | |
| Equipment failure rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tian'an Jiang, PhD. | Contact | +8618857127666 | tiananjiang@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33724066 | Background | Meijerink MR, Ruarus AH, Vroomen LGPH, Puijk RS, Geboers B, Nieuwenhuizen S, van den Bemd BAT, Nielsen K, de Vries JJJ, van Lienden KP, Lissenberg-Witte BI, van den Tol MP, Scheffer HJ. Irreversible Electroporation to Treat Unresectable Colorectal Liver Metastases (COLDFIRE-2): A Phase II, Two-Center, Single-Arm Clinical Trial. Radiology. 2021 May;299(2):470-480. doi: 10.1148/radiol.2021203089. Epub 2021 Mar 16. | |
| 35210014 |
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| OTHER |
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| RF Ablation System | Device | RF Ablation System |
|
| 1 day |
| Result |
| Su GL, Altayar O, O'Shea R, Shah R, Estfan B, Wenzell C, Sultan S, Falck-Ytter Y. AGA Clinical Practice Guideline on Systemic Therapy for Hepatocellular Carcinoma. Gastroenterology. 2022 Mar;162(3):920-934. doi: 10.1053/j.gastro.2021.12.276. |
| 34239808 | Result | Kudo M, Kawamura Y, Hasegawa K, Tateishi R, Kariyama K, Shiina S, Toyoda H, Imai Y, Hiraoka A, Ikeda M, Izumi N, Moriguchi M, Ogasawara S, Minami Y, Ueshima K, Murakami T, Miyayama S, Nakashima O, Yano H, Sakamoto M, Hatano E, Shimada M, Kokudo N, Mochida S, Takehara T. Management of Hepatocellular Carcinoma in Japan: JSH Consensus Statements and Recommendations 2021 Update. Liver Cancer. 2021 Jun;10(3):181-223. doi: 10.1159/000514174. Epub 2021 May 19. |
| 32978054 | Result | Ruarus AH, Barabasch A, Catalano O, Leen E, Narayanan G, Nilsson A, Padia SA, Wiggermann P, Scheffer HJ, Meijerink MR. Irreversible Electroporation for Hepatic Tumors: Protocol Standardization Using the Modified Delphi Technique. J Vasc Interv Radiol. 2020 Nov;31(11):1765-1771.e15. doi: 10.1016/j.jvir.2020.02.030. Epub 2020 Sep 22. |
| 34057003 | Result | Freeman E, Cheung W, Ferdousi S, Kavnoudias H, Majeed A, Kemp W, Roberts SK. Irreversible electroporation versus radiofrequency ablation for hepatocellular carcinoma: a single centre propensity-matched comparison. Scand J Gastroenterol. 2021 Aug;56(8):942-947. doi: 10.1080/00365521.2021.1930145. Epub 2021 May 30. |
| 39707376 | Derived | Cheng C, Xu M, Pan J, Chen Q, Li K, Xu D, Jing X, Lu Q, Yang H, Zhao Q, Deng Z, Jiang T. A multicenter, randomized, parallel-controlled clinical trial protocol to evaluate the safety and efficacy of irreversible electroporation compared with radiofrequency ablation for the treatment of small hepatocellular carcinoma. World J Surg Oncol. 2024 Dec 20;22(1):332. doi: 10.1186/s12957-024-03614-z. |