| Malignant obstructive jaundice(MOJ)is a tumor-related stricture or narrowing of the bile ducts,causing biliary obstruction,and bile cannot be smoothly flowed into the intestinal tract to aid digestion.Cholestasis in the liver can lead to various pathophysiological dysfunctions in short terms,such as yellowing of the skin and mucous membranes,deterioration of liver function,electrolyte disturbance,coagulation mechanism disorder,intestinal dysfunction,and eventually death of the patient.The vast majority of patients with MJO have lost the opportunity for surgery.Therefore,palliative treatment is often chosen to reduce the symptoms of jaundice in clinical practice,which can help to improve liver function,and prolong the survival of patients.Percutaneous hepatic biliary drainage and biliary stenting are usually closed for the most commonly treatments of MJO.Recently,it has been confirmed that the curative effect of biliary stent combined with 125I seed strips was significantly better than that of simple biliary stent implantation in the treatment of MOJ.However,little reports concerned the damage of 125I seed strips implantation to the radiation injury of bile duct,and also the implantation methods were simple with many complications.In current study,animal experiments and clinical investigation were carried out to explore the problems,which was further provide theoretical basis for clinical application by optimizing the implantation method of 125I seed strips.Part Ⅰ Experimental Study on Radiation Injury Caused byIntraluminal Implantation of Radioactive 125I Seeds in Pig Biliary Duct Objective To observe the degree and range of radiation damage to the normal bile duct wall caused by implantation of radioactive 125I seed strands into each segment of the bile duct in pigs,and to explore the feasibility and safety of intraluminal treatment with radioactive 125I seeds.Methods Nine domestic pigs were enrolled in current experiments,and were randomly divided into experimental groups(n=6)and control groups(n=3).In experimental groups,a total number of three 125I seeds within the radioactivity of 0.7mCi loaded in the catheter to make as a seed strand was used.In control groups,a blank catheter within nothing was used.Two seed strands were planted into hilar bile duct,two into common hepatic duct through the opening of the cystic duct and two into the common bile duct through the sphincter of Oddis in the experimental groups.Correspondently,one bland seed strand was planted into hilar bile duct,one into common hepatic duct through the opening of the cystic duct and one into the common bile duct through the sphincter of Oddis as control.The venous blood was collected for biochemical and blood routine examination before and 1 month after operation.Comparing and analyzing blood data between experimental and control groups was to obtain key conclusions.The experimental animals were sacrificed one month after the operation,and the seed strands and corresponding segment of the bile duct and surrounding structures were taken out.After being fixed with solution,the specimens were made for observing pathological changes by using light microscope.Results No postoperative complications,such as incision infection,bleeding,and bile duct perforation were found in experimental animals.There was no significant difference in liver and kidney function between experimental and control group before and one month after operation(P>0.05).The mainly pathological changes included necrotic,partly repair in the columnar epithelium of the intrahepatic bile duct,completely intrinsic glands under the bile duct mucosa,and inflammatory cell infiltration and collagen fiber proliferation in the bile duct surrounding the seed strands.In addition to segmental changes in the cystic duct,the epithelium of the cystic duct appeared necrotic shedding and proliferative repair,and the surrounding inflammatory cells infiltrated.The villous epithelium near the duodenal papilla in the Oddis sphincter section had necrosis and a large number of inflammatory cells infiltrated.In generally,the submucosal glandular structure of each segment of the bile duct was intact,and no necrosis and perforation of the bile duct wall were found.In the control group,the structural of bile duct columnar epithelium and submucosal gland structure was intact.The cystic duct epithelium had no necrosis,and the intestinal villi epithelium near the duodenal papilla in the Oddis sphincter had no necrosis and only a little amount of inflammatory cell exudation.There were significant differences in the pathological results within two groups.Conclusions The implantation of radioactive 125I seeds into the bile duct lumen has a certain degree of radiation damage to the bile duct epithelium.Repair changes can be seen in the bile duct after one month of implantation,and the structure of the submucosal glands was basically intact.Intraluminal implantation of radioactive 125I seeds in the bile duct was safety under the routine clinical irradiation dose.The design scheme and implementation process of this experiment were feasible and repeatable.The current investigation provided a certain theoretical basis for the clinical use of radioactive 125I seed brachytherapy in the treatment of malignant obstructive jaundice.Part Ⅱ Clinical Application Research of Radioactive 125I Seed Stent in Treatment of Low Malignant Obstructive JaundiceObjective To explore the clinical efficacy and safety of metal stents based on the improvement of the traditional straight 125I seed stent production and implantation method.Methods 139 patients with low malignant obstructive jaundice(MOJ)received two different implantation methods of radioactive 125I seed stents and metal stent were enrolled from January 2018 to June 2022 in our hospital.In experimental group,56 patients were treated with seed stents made them into helical shapes and implanted into the cavity of metal stents.In control group,83 patients were treated with seed stents made them into straight shapes and implanted into the gap of metal stents and the bile duct wall,which was commonly used in clinical practice.The results of biochemical,blood routine testing,the complications,the survival of patients and stent patency were compared between two groups before and 1 month after operation.Results The biochemical results in control group included albumin 31.51±4.27 g/L,change to 39.46±2.18 g/L one month after operative;total bilirubin 249.48±40.28μmol/L,change to 23.45±8.78 μmol/L one month after operative;direct bilirubin 224.73±26.98 μmol/L,change to 17.62±5.47μmol/L one month after operation;alanine aminotransferase 218.27±44.40 U/L,change to 91.89±28.55 U/L 1 month after operation;Aspartate aminotransferase 201.75±41.59 U/L,change to 86.31±27.61 U/L one month after operation.The patient’s liver function improved significantly at one month after operation,and the ability of albumin synthesis was significantly enhanced compared with time before operation.The difference was statistically significant(P<0.001).The biochemical results in experimental group included albumin 32.51±4.86 g/L,change to 40.07±2.59 g/L one month after operative;total bilirubin 237.57±40.41μmol/L,change to 22.71±9.10 μmol/L one month after operative;direct bilirubin 214.93±37.34 μmol/L,change to 16.53±4.41 μmol/L one month after operative;alanine aminotransferase 202.96±53.61 U/L,change to 79.59±34.29U/L one month after operative;aspartate aminotransferase 184.00±46.88 U/L,change to 70.88±27.50 U/L one month after operation.The liver synthesis ability was significantly enhanced,and difference was statistically significant(P<0.001).There was no statistically significant difference with other biochemical results between two groups except for the level of alanine aminotransferase one month after operation(P<0.05).The blood routine indicators in two groups were compared.The white blood cell level was significantly decreased one month after operation,and the difference was statistically significant(P<0.001).No significant difference was found with the percentage of neutrophils between experimental and control groups whether before operation or one month after operation(P<0.05).The hemoglobin level showed higher before operation compared with one month after operation(P<0.05).There was no significant difference in white blood cell count,percentage of neutrophils,and hemoglobin in two groups between before operation or one month after operation(P>0.05).The median patency time of seed stents in the control group was 269.0 days,and the average patency time was 271.54±32.88 days.The median patency time of seed stents in the experimental group was 299.0 days,and the average patency time was 301.41±28.09 days.There was a significant difference of patency time between two groups(P<0.001).The median survival time of patients in the control group was 300.0 days,and the average survival time was 307.78±41.67 days.The median survival time of patients in the experimental group was 367.0 days,and the average survival time was 364.50±52.65 days.There was a significant difference of survival time between two groups(P<0.001).The incidence of complications in the two groups were analyzed.The incidence of intraoperative nausea/vomiting,abdominal pain,biliary tract hemorrhage,and biliary heart reflex in the control group was significantly higher than that in the experimental group,and the differences between the two groups were statistically significant(P<0.05).The incidences of postoperative abdominal pain,fever,biliary tract hemorrhage,and bile fistula in the control group were also significantly higher than those in the experimental group,and the differences between the two groups were statistically significant(P<0.05).In addition,there were 7 cases in the control group and 1 in the experimental group was considered biliary peritonitis,but the difference was not statistically significant(P>0.05).Conclusions Radioactive 125I seed stents implantation in the treatment of low malignant obstructive jaundice can help patients control infection in a short time,improve liver function,and relieve jaundice symptoms.Compared with the traditional implantation of straight 125I seed stents in the treatment of low malignant obstructive jaundice,the implantation of spiral 125I seed stents can reduce the occurrence of surgery-related complications and improve the comfort of patients during surgery.In terms of long-term efficacy,the implantation of spiral 125I seed stents can prolong the patency time of the stent and the patient’s survival period.Part Ⅲ Clinical Application Research of Radioactive 125I Seed Stent in Treatment of High Malignant Obstructive JaundiceObjective To explore the clinical efficacy and safety of spiral radioactive 125I seed stents combined metal stent implantation in the treatment of high malignant obstructive jaundice.Methods 142 patients with high malignant obstructive jaundice admitted to our hospital from December 2017 to September 2022 were analyzed.In the experimental group,75 cases were implanted with spiral seed stents combined with bare metal stents,and the seed stents were implanted into the cavity of the stent.In the control group,67 cases were implanted with straight seed stents combined with bare metal stents,and the seed stents were placed at the gap of the stent and the wall of the bile duct.The results of biochemical,blood routine testing,the complications,the survival of patients and stent patency were compared between two groups before and 1 month after operation.Results The biochemical results in control group included albumin 32.61±3.88 g/L,change to 39.46±2.18 g/L one month after operative;total bilirubin 240.36±28.20μmol/L,change to 82.38±42.98 μmol/L one month after operative;direct bilirubin 234.55±17.19 μmol/L,change to 71.42±11.43 μmol/L one month after operation;alanine aminotransferase 174.57±48.97 U/L,change to 86.48±22.84 U/L 1 month after operation;Aspartate aminotransferase 171.39±40.58 U/L,change to 88.92±25.44 U/L one month after operation.The patient’s liver function improved significantly at one month after operation,and the ability of albumin synthesis was significantly enhanced compared with time before operation.The difference was statistically significant(P<0.001).The biochemical results in experimental group included albumin 34.25±3.98 g/L,change to 39.14±3.87 g/L one month after operative;total bilirubin 233.68±38.22μmol/L,change to 58.01±39.28 μmol/L one month after operative;direct bilirubin 227.25±28.11 μmol/L,change to 47.51±22.07 μmol/L one month after operative;alanine aminotransferase 173.52±53.39 U/L,change to 77.71 ±28.43 U/L one month after operative;aspartate aminotransferase 166.16±46.04 U/L,change to 78.77±24.72 U/L one month after operation.However,the improvement of liver function in the experimental group was significantly better than that of the control group at one month after operation,the difference was statistically significant(P<0.05).The blood routine indicators in two groups were compared.The white blood cell level was significantly decreased one month after operation,and the difference was statistically significant(P<0.001).There was significant difference was found with the percentage of neutrophils between experimental and control groups whether before operation or one month after operation(P<0.05).The hemoglobin level showed higher before operation compared with one month after operation(P<0.05).There was no significant difference in white blood cell count,percentage of neutrophils,and hemoglobin in two groups between before operation or one month after operation(P>0.05).The patency time and survival period of the two groups were also compared.The median patency time of the seed stents in the control group was 256.0 days,and the average patency time was 259.46±31.62 days.The median patency time of the seed stents in the experimental group was 270.0 days,and the average patency time was 269.28±28.06 days,and there was no significant difference in the stent patency time between two groups(P>0.05).The median survival time of patients in the control group was 290.0 days,and the average survival time was 293.76±30.12 days.The median survival time of patients in the experimental group was 301.0 days,and the average survival time was 301.95±29.05 days.The incidence of complications in the two groups were analyzed.The incidence of intraoperative nausea/vomiting,abdominal pain,biliary tract hemorrhage,and biliary heart reflex in the control group was significantly higher than that in the experimental group,and the differences between the two groups were statistically significant(P<0.05).The incidences of postoperative abdominal pain,fever,biliary hemorrhage,and bile fistula in the control group were significantly higher than those in the experimental group,and the difference was statistically significant(P<0.05).Drainage tube slippage occurred in 5 cases in the control and none in experimental group,but the difference was not statistically significant(P>0.05).Conclusions Radioactive 125I seed stents combined with metal stent implantation and percutaneous hepatic puncture or drainage in the treatment of high malignant obstructive jaundice can help patients improve liver function,relieve jaundice symptoms,and control biliary tract infection.The implantation method of spiral 125I seed stents combined with metal stents has less damage to the biliary tract and punctured sinus tract.The implantation method of the spiral seed stent can reduce the occurrence of surgery-related complications and improve the comfort and tolerance of patients during surgery.In terms of long-term efficacy,the implantation of helical 125I seed stents combined with metal stents has no obvious advantages. |
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