| PurposeThe research evaluated therapeutic efficacy and safety of domestically produced nano-knife which is based on principle of irreversible electroporation(IRE)by the randomized controlled trial of CT / ultrasonic-guided nano-knife / radiofrequency(RF)ablation in the treatment of local liver malignant tumors(LLMT),and explored the application value of domestically produced nano-knife in the treatment of patients with local liver cancer.MethodsA total of 24 patients with LLMT who were admitted to the General Hospital of Tianjin Medical University from November 2018 to September 2019.Pre-procedure imagine(CT/MRI/PET-CT)and laboratory baseline examinations(blood routine examination,coagulation function,biochemical test,tumor markers,etc)were examined.Patients were randomly divided into nano-knife group and RF group,imagine suggest that patients with malignant liver tumors in special sites where radiofrequency ablation is not applicable was classified into the nano-knife group according to medical ethics principles.According to the patient’s condition and treatment plan,CT-guided percutaneous puncture nano-knife / RF ablation treatment and open surgery ultrasound-guided nano-knife / RF ablation treatment were adopted.The intraoperative,postoperative complications were recorded.Postoperative imaging,laboratory examinations were compared with baseline examinations.Based on the imaging changes of ablation lesions,combined laboratory test results and the occurrence of complications,therapeutic nano-knife efficacy and safety were comprehensively evaluated.ResultsThe research included 24 patients(17 males and 7 female,median age 55.5,44-70)with LLMT(hepatocellular carcinoma,n=8;cholangiocarcinoma,n=2;colorectal cancer liver metastasis,n=5;gastric adenocarcinoma liver metastasis,n=2;lung adenocarcinoma liver metastasis,n=2;lung squamous cell carcinoma liver metastasis,n=1;breast ductal adenocarcinoma liver metastasis,n=1;pancreatic ductal adenocarcinoma liver metastasis,n=1;pancreatic neuroendocrine tumor liver metastasis,n=1).All the procedures were completed successfully.CT / ultrasound examination was performed immediately after the operation,and the ablation area showed low density / low echo changes,part of the characteristic gas shadow was seen,and the surrounding blood vessels,pancreatic ducts and other important tissue structures were not seriously damaged.Postoperative 90-day imaging showed that 17 patients(IRE:RF=6:11)reached complete response(CR),5 patients(IRE:RF=3:2)reached partial response(PR),1 patients(RF)reached stable disease(SD),2 patients(IRE)reached progressive disease(PD).There was no difference in efficacy between nano-knife group and RF ablation group(p=0.291).Intraoperative complications included subcapsular hematoma(n=1),tachycardia(n=4),hypertension(n=5,reached 180/110 mm Hg)and postoperative complications included fever,vomiting,pain(n=14),blood transfusion(n=1),infection(n=2),wound dehiscence(n=1),hematochezia(n=1).Postoperative 7-day,30-day imaging showed local hemorrhage(n=1),cholangitis(n=1),portal vein and splenic vein thrombosis(n=1),cholangiectasis(n=3),hemadostenosis(n=3).Two patients had death / multiple organ failure within 90 days.According to Clavien-Dindo classification criteria,the total complication rate was 42%(n=10/24).Nano-knife ablation treatment for lesions near the vascular or bile duct shows that the lesions adjacent to portal vein have poor prognosis and serious complications.ConclusionCT-guided percutaneous IRE ablation is an effective,safe,minimal invasive ablative approach.In comprehensive evaluation of efficacy and safety of this research,nano-knife ablation reflects the effect not inferior to radiofrequency ablation.It can be considered that nano-knife is basically equivalent to radio frequency ablation in local liver malignant tumors.At the same time,nano-knife ablation shows the potential value of selective ablation for lesions adjacent to special structures such as blood vessels and biliary tract.Nano-knife has broad clinical application prospects. |
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