Clinical Study Of Biliary Stent Implantation Combined With Different Configurations Of ¹²⁵I Particle Chain Intrabiliary Irradiation In The Treatment Of Malignant Obstructive Jaundice

Objective:To investigate the clinical effect of biliary stent implantation combined with traditional linear ¹²⁵I particle chain irradiation in the treatment of malignant obstructive jaundice（MOJ）.Clinical value of biliary stent implantation combined with modified ¹²⁵I particle chain shaping along natural curvature of biliary tract in the treatment of malignant obstructive jaundice:Classification of ¹²⁵I particle chain catheter and feasibility of manual manufacture.Methods:A retrospective analysis was made on 96 patients with MOJ admitted to Nanjing hospital affiliated to Nanjing medical university and jiangyin hospital affiliated to southeast university from June 2015 to October 2017.all patients were treated with percutaneous transhepatic biliary drainage（PTCD）for one week.According to different follow-up treatment methods,they were divided into experimental group（n=41）and control group（n=55）.The control group was treated with biliary stent implantation only,while the experimental group was treated with biliary stent implantation combined with ¹²⁵I particle chain brachytherapy.Two groups of patients were guided by digital subtraction angiography（DSA）equipment to perform percutaneous transhepatic biliary stent implantation.In the experimental group,¹²⁵I particle chain were implanted during the operation and then fixed between the biliary wall and stent.The liver function indexes,serum tumor marker carbohydrate antigen199（CA199）levels,postoperative biliary tract patency time,short-term clinical efficacy,survival time and complications were compared between the two groups.A retrospective analysis was made on 60 MOJ patients who met the selection criteria from June,2017 to December,2019.Thirty patients who used traditional linear particle chain irradiation during operation were set as control group,and 30patients who used arc particle chain irradiation during operation were set as experimental group.Both groups were treated with percutaneous transhepatic biliary drainage one week before combined stent implantation.The liver function indexes aspartate aminotransferase,AST),alanine aminotransferase,ALT),total bilirubin,TBIL),direct bilirubin,DBIL),serum tumor marker CA199,postoperative biliary tract patency time,short-term clinical efficacy and survival time were compared between the two groups at 1 month and 3 months after operation,respectively.Try to make catheters(¹²⁵I particle carriers)with different configurations by hand using image analysis post-processing technology,coaxial forming technology and baking technology,and classify them according to their structures.Results:All 96 patients were operated successfully.There were no complications such as biliary perforation,bleeding and biliary tract infection in the two groups after operation.The levels of serum TBIL in the experimental group were（116.1±45.1）μmol/l,（32.6±19.2）μmol/l and（24.2±8.6）μmol/l at 1 week,1 month and 3 months after operation,which were significantly lower than those in the control group（176.8±57.4）μmol/l,（107.8±20.2）μmol/l and（73.1±12.1）μmol/l respectively.Serum DBIL levels in the experimental group were（68.6±37.0）μmol/l,（23.4±12.4）μmol/l and（18.9±7.6）μmol/l at 1 week,1 month and 3 months after operation,which were significantly lower than those in the control group（124.4±45.8）μmol/l,（97.4±12.5）μmol/l and（68.3±10.0）μmol/l respectively.Serum ALT levels were（57.4±26.7）u/l,（30.4±16.5）u/l and（24.6±7.3）u/l,which were significantly lower than those of the control group（180.3±29.6）u/l and（85.9±19.8）u/L.Serum AST levels were（52.0±19.1）u/l,（30.7±13.2）u/l and（30.5±10.1）u/l,which were significantly lower than those of the control group（92.3±19.7）u/l and（71.4±18.9）u/L.Serum CA199 levels in the experimental group were（180.3±58.4）u/ml and（168.9±68.6）u/ml one month and three months after operation,which were significantly lower than those in the control group（278.6±135.6）u/ml and（320.5±158.9）u/ml,respectively.The average time of bile duct patency in the experimental group was（6.4±3.8）months,which was significantly longer than that in the control group（2.9±1.8）months,P<0.05.The effective rate of the experimental group was 53.7%,which was significantly higher than that of the control group（30.9%,P<0.05）.The median survival time of the experimental group was10.7 months,which was significantly longer than that of the control group（6.2months,P<0.05）.All 60 patients successfully completed the operation.Serum TBIL in the experimental group was（84.8±60.7）μmol/l and（24.8±13.4）μmol/l one month and three months after operation,respectively,which was lower than that in the control group（90.7±61.2）μmol/l and（25.5±13.3）μmol/l;Serum DBIL in the experimental group was（72.3±51.8）μmol/l and（19.1±12.7）μmol/l one month and three months after operation,respectively,which was lower than that in the control group（77.5±52.4）μmol/l and（20.0±12.5）μmol/l;Serum ALT was（44.9±32.5）u/l and（25.0±17.4）u/l,which was lower than that of control group（45.8±31.8）u/l and（25.2±17.3）u/l;Serum AST in experimental group was（45.2±25.1）u/l lower than that in control group（45.7±24.7）u/l one month after operation,and（41.0±38.8）u/l in experimental group was higher than that in control group（34.0±17.0）u/l three months after operation.Serum CA199 levels in the experimental group were（315.1±289.1）u/ml and（279.7±259.5）u/ml one month and three months after operation,respectively,which were higher than those in the control group（307.4±289.5）u/ml and（268.9±263.2）u/ml.The average time of bile duct patency in experimental group was（7.1±4.1）months,which was higher than that in control group（6.5±2.6）months.The effective rate of the experimental group was56.7%,which was higher than that of the control group（53.3%）.The median survival time of the experimental group was 7 months,which was the same as that of the control group.In the experimental group,there was 1 case of particle chaine shift,which was lower than that in the control group（8 case）.Compared with the traditional biliary stent combined with particle chain method,the curative effect（liver function TBIL,DBIL,ALT,AST improved,serum CA199 decreased,stent patency time,treatment efficiency,survival time）of the treatment of MOJ was basically equivalent（P>0.05,there was no significant difference between the experimental group and the control group）,and the particle chain shift in complications was significantly improved（P<0.05）.Straight-line,planar and three-dimensional catheters can be successfully manufactured by manual method.Conclusion:Biliary stent implantation combined with brachytherapy with linear ¹²⁵I particle chain implantation in biliary tract cavity is superior to biliary stent implantation alone in the treatment of jaundice regression,tumor suppression and prolonging the survival time of patients.The modified ¹²⁵I particle chain with enhanced radian compliance（along the natural radian of biliary tract）can reduce the risk of particle chain displacement,and can achieve no less curative effect than biliary stent combined with traditional linear¹²⁵I particle chain brachytherapy in the aspects of jaundice regression,tumor growth inhibition,survival time and stent patency time.It is feasible to make ¹²⁵I particle chain carriers with different configurations by hand with appropriate technology.