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Objective:To evaluate the effectiveness and safety of the home-made umbrella-shaped Octoparms inferior vena cava filter in the prevention of pulmonary embolism.Methods:A multicenter, randomized, positive parallel controlled, non-inferiority clinical trial was conducted in ten hospitals in China from October 2017 to March 2019. A total of 188 subjects were enrolled according to the same inclusion and exclusion criteria in different institutes. The 188 subjects were randomly divided into the trial group or the control group according to 1∶1 by the central randomization system, with 94 cases in each group. Octoparms inferior vena cava filter was used in the trial group, and the Celect inferior vena cava filter in the control group. The primary effective index was clinical success rate,including the clinical success rate of filter placement and filter retrieval. The secondary index included the rate of manual success of the delivery sheath system,incidence of pulmonary embolism(within 6 months), incidence of filter fracture,migration (>20 mm),tilt(>15°) on insertion/retrieval,and the situation of inferior vena cava flow(within 6 months). Safety evaluation included the incidence of filter related complications and device-related adverse events immediately after surgery and during follow-up.Results:The success rate of implantation was 100% in 188 subjects. Filter retrieval was performed in 87 cases (92.55%) in the trial group and 91 cases (96.81%) in the control group. The clinical success rate of the trial group was 97.87%(92/94) and that of the control group 98.94%(93/94). There was no significant difference between the two groups (χ 2=0.77, P=0.380). The success rate of delivery sheath system was 96.81%(91/94) and 98.94%(93/94) in the trail group and the control group,respectively. There was no significant difference between the two groups( P=0.621). There was 1 case (1.22%) of new asymptomatic pulmonary embolism in the trial group after filter placement and 2 cases (2.44%) in the control group. There was no significant difference between the two groups ( P>0.05). No filter fracture or migration (>20 mm) occurred in either group. The tilting of filter (>15°) was found in 1 case (1.06%) in the test group and 1 case (1.06%) in the control group when the filter was placed. The tilting of filter (>15°) was found in 0 case in the test group and 2 cases (2.44%) in the control group when the filter was retrieved. There was no significant difference between the two groups ( P>0.05). Inferior vena cava thrombosis before filter retrieval was found in 5 cases (5.75%) in trial group and 3 cases (3.30%) in control group. There was no significant difference between the two groups ( P=0.489). There were no immediate serious complications during filter placement/removal in either group. No filter obstruction,migration,deformation,penetration and occlusion of inferior vena cava. The incidence of device-related adverse events was low in both group. There was no significant difference between the two groups ( P>0.05). Conclusion:The home-made umbrella-shaped Octoparms inferior vena cava filter is effective and safe in preventing pulmonary embolism, and is not worse than Celect filter.
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Objective To assess the efficacy and safety of different diameter covered stents used in transjugular intrahepatic portosystemic shunt (TIPS) for esophagogastric varices with bleeding (EGVB). Methods The clinical data of 68 patients with portal hypertension due to cirrhosis, who received TIPS for EGVB during the period from Desember 2010 to February 2015, were retrospectively analyzed. Among the 68 patients, covered stent with diameter of 7mm was used in 30 (small stent group) and covered stent with diameter of 8mm was employed in 38 (big stent group). Using Kaplan-Meier method, the cumulative digestive tract no-rebleeding rate, the patency rate of shunt and the survival rate of both groups were analyzed. Logrank test was used to make comparison between the two groups, and chi-square test was conducted to compare the incidence of hepatic encephalopathy between the two groups. Results The operative success rate was 100％ in 68 patients. The patients were followed up for 0.1-52.3 months, with a mean of (19.4±16.0) months. The 3-, 6-and 12-month cumulative digestive tract no-rebleeding rates were 86.54％, 79.30％ and 74.90％ respectively in the small stent group, which were 91.87％, 85.93％ and 81.63％ respectively in the big stent group, but the differences between the two groups were not statistically significantly (X2=0.05, P=0.83). The 3-, 6-and 12-month cumulative patency rates of shunt in the small stent group were 95.00％, 80.19％ and 70.17％ respectively, which in the big stent group were 96.15％, 91.97％ and 81.07％ respectively, and no statistically significant differences existed between the two groups (X2=0.40, P=0.53). The 3-, 12-, 24-and 48-month cumulative survival rates in the small stent group were 93.33％, 86.67％, 75.11％ and64.38％ respectively, while those in the big stent group were 97.37％, 94.23％, 88.68％ and 76.02％ respectively, and the differences between the two groups were not statistically significantly (X2=2.21, P=0.14). Postoperative hepatic encephalopathy occurred in 15 patients (15/68, 22.06％), the incidences of hepatic encephalopathy in the small stent group and in the big stent group were 20.00％ (6/30) and 23.68％ (9/38) respectively, the difference between the two groups was not statistically significantly (X2=0.13, P=0.72). Conclusion Compared with the use of 7mm covered stent, the use of 8mm covered stent in TIPS neither can improve the curative effect nor can reduce the incidence of hepatic encephalopathy.
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Objective To assess the efficacy and safety of transjugular intrahepatic portasystemic shunt (TIPS) with Viatorr covered stent in patients with portal hypertension-related complications.Methods Clinical data of 8 patients with por-tal hypertension-related complications were analyzed retrospectively.All the cases received TIPS with Viatorr covered stent.After the operation,the followed up was used to evaluate the therapeutic effect of TIPS by enhanced CT scan.Results All the operations of TIPS were technically successful.And all the cases were treated with Viatorr covered stents with diameter of 8 mm and covered segment length of 50-80 mm.For 1 case with cavernous transformation of portal vein,a 8 mm×40 mm E-Luminexx bare stent was implanted in the portal vein side.For 1 case with hepatic vein stenosis,a 8 mm× 40 mm Fluency covered stent was implanted in the hepatic vein side.After the operation,the portal pressure reduced from (33.08 [29.32,40.22])mmHg (preoperative) to (23.31 [21.43,26.51])mmHg (postoperative) with statistical difference (Z=-2.52,P=0.012).The patients were followed up for 1.1-7.7 months,and all the patients were alive without complications of portal hypertension.There were 2 cases with mild hepatic encephalopathy after operation.During the reexamination time of 1-7.7 months,all TIPS shunts remained patency.Conclusion TIPS with Viatorr stent is a safe and effective treatment for patients with portal hypertension-related complications.
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Objective To assess the efficacy and safety of transjugular intrahepatic portasystemic shunt (TIPS) with Viatorr covered stent in patients with portal hypertension-related complications.Methods Clinical data of 8 patients with por-tal hypertension-related complications were analyzed retrospectively.All the cases received TIPS with Viatorr covered stent.After the operation,the followed up was used to evaluate the therapeutic effect of TIPS by enhanced CT scan.Results All the operations of TIPS were technically successful.And all the cases were treated with Viatorr covered stents with diameter of 8 mm and covered segment length of 50-80 mm.For 1 case with cavernous transformation of portal vein,a 8 mm×40 mm E-Luminexx bare stent was implanted in the portal vein side.For 1 case with hepatic vein stenosis,a 8 mm× 40 mm Fluency covered stent was implanted in the hepatic vein side.After the operation,the portal pressure reduced from (33.08 [29.32,40.22])mmHg (preoperative) to (23.31 [21.43,26.51])mmHg (postoperative) with statistical difference (Z=-2.52,P=0.012).The patients were followed up for 1.1-7.7 months,and all the patients were alive without complications of portal hypertension.There were 2 cases with mild hepatic encephalopathy after operation.During the reexamination time of 1-7.7 months,all TIPS shunts remained patency.Conclusion TIPS with Viatorr stent is a safe and effective treatment for patients with portal hypertension-related complications.
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With the rapid development of medical imaging equipment, the higher requirement for the practice skills of the medical imaging professionals has been put forward. The traditional “CT and MR diagnostics” experimental teaching has some disadvantages, such as poor quality of images, imbalance of teaching resources, students' lack of practical skills training, no reflection of the practi-cal skills in the course examination and so on. They are not conducive to the cultivation of talents. Aimed to improve the experimental teaching quality of the course and students' practical skills, the reformative teaching method and means have been carried out, such as improving the laboratory facil-ities , composing experimental guidance , encouraging students to learn actively , strengthening the examination of practical skills, cultivating teachers in many different ways and so on. Through the survey, 92.9% of the students expressed satisfaction with the experimental course teaching reform. These measures will also be used in the teaching of all the sub courses of medical imaging diagnostics to promote the medical imaging professional training.
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Objective To investigate the clinical efficacy of percutaneous transhepatic insertion of biliary stent (PTIBS) combined with radioactive seed implantation in treating malignant biliary obstruction. Methods A total of 38 patients with malignant biliary obstruction were enrolled in this study. Radioactive 125I seed was used, and each 125I seed was 4.5 mm in length and 0.8 mm in diameter. The 125I seeds were placed in a catheter to prepare the 125I seed- strip. PTCD was carried out first, then percutaneous catheterization was performed and a guide- wire was inserted through the catheter until it passed the obstructed biliary segment. The obstructed segment was dilated by a balloon - catheter, which was followed by PTIBS. An 8 - 10 F drainage - catheter was placed into the biliary duct through the stent. Finally, guided by fluoroscopy the catheter with the 125I seed- strip was inserted via the drainage- catheter to the area that was planned to be radiated. The external drainage- catheter was wrapped and fixed to the skin, or was imbedded under the skin. Results Of the 38 patients with malignant biliary obstruction, successful PTIBS combined with radioactive seed implantation was accomplished in 36 patients. After the treatment, the serum bilirubin level fell to normal or near normal range in all patients (P < 0.05). No obvious side effects were observed. Conclusion For the treatment of malignant biliary obstruction, percutaneous transhepatic insertion of biliary stent combined with radioactive 125I seed - strip implantation is a safe and effective method.
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Objective To evaluate the treatment effect of balloon angioplasty and cryoplasty on iliac artery stenosis in canine model.Methods Canine models of iliac artery stenosis were established with surgical ligation and transfixion.Models were randomly divided into two groups:iliac artery stenosis treated by cryoplasty (n =8) and by balloon angioplasty (n =8).The degree of iliac artery stenosis of two model groups was assessed by digital subtraction angiography (DSA) immediately and two weeks after the angioplasties.Then all the dogs were executed for pathological observation of the target vessels.Results Sixteen canine models of iliac artery stenosis were established by surgical ligation and transfixion method with 100％ success rate.DSA showed there was (45 ± 12)％ of residual artery stenosis in the cryoplasty group immediately after surgery,while it was (39-12)％ in the balloon angioplasty group,and there was no significant difference between them(t =3.183,P ＞ 0.05).The artery stenosis of cryoplasty group was (48 ± 17) ％ after two weeks and not significantly different from that after surgery immediately (t =-1.271,P ＞ 0.05).The artery stenosis of balloon angioplasty group was (67 ± 13)％ after two weeks,and it was significantly higher compared with at after surgery immediately (t =-6.666,P ＜ 0.01).The degree of vascular stenosis in balloon angioplasty group was severer than that in cryoplasty group two weeks after angiography(P =0.041).The pathological examination showed artery intimal hyperplasia in cryoplasty group was milder than that in balloon angioplasty group and neointimal content of collagen in cryoplasty group was less than that in balloon angioplasty group.Conclusions The animal models of iliac artery stenosis were established successfully with surgical ligation and transfixion by damaging the intima and media of arterial wall.Compared with balloon angioplasty,the cryoplasty was able to inhibit proliferation of intimal and reduce collagen synthesis to prevent the iliac artery restenosis.
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Objective To evaluate the clinical therapeutic effect with microspheres embolization for giant hepatocellular carcinoma(HCC). Methods A prospective study was performed for 156 HCC patients needed for TACE, then randomly signed them into group M (embolized by microspheres alone), group L (embolized by lipiodol alone) and group M + L (embolized by microspheres combined with lipiodol). TACE of group M was performed by 300-700 μm microspheres. Group L selected lipiodol alone to embolize. While group M + L were embolized by about 1/3-1/2 lipiodol of total embolized volume and then microspheres feeding individual tumor vessels. Stoped the procedure when caused terminal vessel blockade. Before and after therapy, patients'liver function, serum α-fetoprotein level (AFP), responses of tumor, complications related to embolization and survive rates of 180 days and 360 days were analyzed among three groups.Enumeration data such as survive rates and positive response were compared by χ2 test, while measurement data were analyzed by one-way classification. Results The positive response (CR + PR) of group M was 38.5% (20/52)and (CR + PR + SD)73. 1% (38/52). Survive rates of 180 days and 360 days were 88. 5% (46/52) and 82. 3% (43/52). While those of group L were 42. 3% (22/52) ,76.9% (40/52),86.5%(45/52), 75.0% (39/52) and group M + L were 55. 8 % (29/52), 88.5 % (46/52), 94. 2% (49/52),86. 5％ (45/52). Significant difference of survival rates and total effective between group M + L and M,M + L and L was found(χ2 = 6. 27,6. 16, P ＜ 0. 05). At the same time adverse responses of incidence and persis time such as febricity, nausea and vomit, hepatic pain were more lower in group M + L and group M.Three groups febricity rate were 63.4% (33/52), 86. 5% (45/52) and 69. 2% (36/52), nausea and vomit were 67.3 % (35/52) ,84. 6% (44/52) and 76. 9% (40/52), hepatic pain were 59. 6% (31/52), 86. 5 %(45/52), 73. 1% (38/52) (χ2 = 6.55, 6. 22, 6. 90, P ＜ 0. 05). Conclusion Embolization with microspheres can get longer and more effective treatment. TACE with microspheres and lipiodol for embolizing HCC was more effective than with Microspheres or lipiodol alone.
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Objective To investigate the effectiveness of gamma-knife radiotherapy combined with stent placement for the treatment of cancerous thrombus in inferior vena cava (IVC) in patients with hepatic carcinoma. Methods Stent placement was performed in 26 patients of hepatic carcinoma associated with cancerous thrombus in IVC,which was followed by gamma-knife radiotherapy for the treatment of thrombus. IVC angiography was reexamined at regular intervals to find out the patent situation and to measure the internal diameter of IVC. Results The internal diameter of IVC was increased in different degree after the treatment. After stent placement the internal diameter of IVC was increased by (0.842 ? 0.283) cm,while the internal diameter of IVC was increased by (1.523 ? 0.195) cm after gamma-knife radiotherapy. The internal diameter of IVC after gamma-knife radiotherapy was significantly greater than that before stent placement (P