| At present,the global annual cancer growth and mortality are increasing year by year,and the cancer situation is getting grim.According to the latest statistics,the number of cancer patients in China is the first in the world.As the demand for tumor treatment gradually increased,making the new method of tumor therapy research and development of domestic and foreign related fields to face a major issue.At the same time,the treatment of tumor-related new equipment research and development work is imminent.Minimally invasive cryoablation therapy is a rapid development of solid tumor therapy in recent years.The main principle is that through physical and chemical means,the tumor tissue placed at very low temperature to achieve the killing of tumor cells.The cryoablation technique was green,minimally invasive and painless.At present,this technology has been widely used in the treatment of solid tumors.The cryocare surgical system(Argon-helium knife)of United States Endcare Company is widely used in clinical treatment of cancer in China.The cryocare surgical system used the aerospace metallic materials to produce frozen probes.The atmospheric inert gas argon was used as a cold medium and helium was used as a heat medium,which resulting in its high prices of refrigeration equipment.In addition,there is a danger about the high-pressure argon and helium’s transporting and storageing.For the minimally invasive cryotherapy technology more and more services to cancer patients,China’s scientific research workers to develop the liquid nitrogen as the main supplies of minimally invasive ultra-cryoablation system(Kangbo knife).This test is to prove that the minimally invasive ultra-cryoablation system in the treatment of advanced non-small cell lung cancer is not inferior to cryocare surgical system.Objective: To evaluate that minimally invasive ultra-cryoablation system in the treatment of advanced non-small cell lung cancer is not inferior to cryocare surgical system.Methods:1 Experiment methodIn this study,a prospective,randomized,parallel controlled,noninferiority clinical trial was designed to evaluate the efficacy of minimally invasive cryotherapy in the treatment of patients with advanced non-small cell lung cancer.Between 2014 and 2016,81 patients with advanced non-small cell lung cancer were enrolled in the 18-80 years of age.The minimally invasive ultra-cryoablation system(Kangbo knife)was a test group of products and the cryocare surgical system(Argon helium knife)was a control product.There were 41 patients were in the experimental group and 40 patients in the control group.The whole operation was guided by CT image.The patients treated with percutaneous puncture argon-helium knife or kangbo knife guided by computed tomograph,respectively.The maximum area of intraoperative frozen ice hockey and the largest area of tumor necrosis after a month of cryoablation were need to record.According to the test results of the above evaluated the efficacy of minimally invasive ultra-cryoablation system.2 The evaluation criteria for effectiveness2.1 The main efficacy indicators2.1.1 Intraoperative hockey coverage to determine the coverage of the effective test group of non-inferiority in the control group.2.1.2 A month after the data in accordance with the evaluation of improved solid tumor efficacy evaluation criteria to determine the total effective rate.The test group was not inferior to the control group.2.2 The secondary efficacy indicators: the feel of pain in assessment group was not inferior to the control group.Results:1 The main effect1.1 The intraoperative ice hockey coverageThe intraoperative ice hockey coverage was evaluated using CT scan images during surgery.The coverage efficiency was determined based on intraoperative ice hockey coverage.There were 77 cases(39 cases in the test group,38 cases in the control group),79 tumor lesions(40 tumor lesions in the experimental group,39 tumor lesions in the control group).In the patient level and the level of the lesion,both groups are covered with ice hockey efficiency is 100%.Respectively,using the Miettinen Nurminen method,approximate normal method,Newcombe method of the three estimates of the two groups of the difference between the estimated values of 0.0%.The absolute value of the 95% confidence interval lower limit of the efficiency difference is less than 10% of the non-inferior boundary value specified in the test scheme.It is concluded that the clinical trial is non inferiority.1.2 The improvement of solid tumor efficacy evaluation criteria to determine the total effective rate after a monthThe ablation lesions were scanned with using CT imaging equipment and the curative effect was evaluated according to the evaluation criteria of the improved solid tumor after a month.At the same time,the total effective rate was determined according to the evaluation results.There were 77 cases(39 cases in the test group,38 cases in the control group),79 tumor lesions(40 tumor lesions in the experimental group,39 tumor lesions in the control group).In the patient level and the level of the lesion,both groups are covered with ice hockey efficiency is 100%.Respectively,using the Miettinen Nurminen method,approximate normal method,Newcombe method of the three estimates of the two groups of the difference between the estimated values of 0.0%.The absolute value of the 95% confidence interval lower limit of the efficiency difference is less than 10% of the non-inferior boundary value specified in the test scheme.It is concluded that the clinical trial is non inferiority.2 The secondary efficacyEvaluation of intraoperative pain in patientsIn the PPS,there was no difference in the pain evaluation between the test group and the control group,which was consistent with the preoperative pain assessment requirement between the two groups.Conclusion: The minimally invasive ultra-cryoablation system in the treatment of advanced non-small cell lung cancer is not inferior to the cryocare surgical system. |
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