| Part Ⅰ The changes of local biliary temperature and bile duct damage during endobiliary radiofrequency ablation in ex-vivo porcine livers[OBJECTIVE]To study the changes of local biliary temperature and bile duct damage during endobiliary radiofrequency ablation (RFA) under different power parameters in the model of ex-vivo porcine liver biliary system.[METHODS]1. Modeling ex-vivo porcine liver biliary system filling with human bile Ten ex-vivo porcine livers were obtained, which with gallbladder and common bile duct reserved. All liver models were connected with the catheter sheath(8 Fr.) at the distal end of common bile duct.Human bile was injected into the porcine biliary tract via catheter sheath,then a few contrast agent(ioversol,320mgI/ml) was injected to depicted the biliary system under DSA fluoroscopy.The intrahepatic and extrahepatic bile duct system filling with bile were confirmed.Guide wire and HabibTM EndoHPB radiofrequency ablation catheter were inserted into the hilar bile duct through the common bile duct via catheter sheath under DSA fluoroscopy.2. Endobiliary RFA with HabibTM EndoHPB radiofrequency ablation catheterEndobiliary RFA was performed in ten ex-vivo porcine livers.The ablation parameters(power/time) were conducted as follows:5W(120s)、6W(120s)、7W (120s)、8W (120s)、9W (120s)、10W (120s).11W (120s)、12W (120s). 13W(120s)、14W(120s).The changes of temperatures at RF A target and and 1cm, 2cm away from the pole were examined with temperature needles respectively under fluoroscopy.After endobiliary RFA,gross changes of bile duct and adjacent tissue were observed,and ablation depth were examined.Pathology changes under microscopy were performed for evaluating the damages of biliary and adjacent tissue aforementioned different area.[RESULTS]After modeling on ex-vivo porcine liver filling with human bile, ten liver bile ducts were successfully ablated. Increasing of temperatures at RFA area were observed in all the models.The higher temperature (up to 90.3℃) was obtained when the higher power was used.The temperatures of the other two sites were not rising obviously(28.4-40.2℃). Varying degrees coagulation necroses of the ablation bile duct area were obtained. The color of bile duct wall changed from light yellow to deep yellow and 2 mm to 4 mm depth of ablation area were observed. The bile permeated bile duct wall after 120 s endobiliary RFA using 8 Walts, and no significant damage were found in adjacent bile duct and liver tissue. The color of bile duct wall changed to deep yellow and unclear adjacent tissue boundaries was observed after the ablation after RFA (14W,120s). Meanwhile, surrounding liver tissue necrosis, bile duct epithelial cells necrosis and exfoliated were also observed. Under different ablation parameters, no significant damage was detected in the bile duct and liver tissues which were lcm and 2cm away from the ablation area.[CONCLUSION]1. Coagulation necroses of the bile duct could be observed after endobiliary RFA under different ablation parameters.The effectiveness of HabibTM EndoHPB radiofrequency ablation catheter could be confirmed.2. Heat transfer to nearby bile duct was confiremed during endobiliary RFA with currently routine ablation power (5-10W) in clinical.However,only slight rising temperature of adjacent biliary was detected, and no significant damage of bile duct was observed. In addition, living tissue contains lots of pipeline systems in the hilar region, the heat can be taken away by the blood flow in portal vein and hepatic artery. Therefore, the damage of the adjacent bile duct was not significant The safety was confirmed by our study.3. The bile duct necrosis can be detected under RFA with low power(5W),it prompted that the ablation electrode can not contact with normal bile duct.Therefore, The correct positioning of the ablation site is very important.Part II Comparative study of the efficacy of stent implantation and percutaneous endobiliary radiofrequency ablation combined with stent[OBJECTIVE]To compare the efficacy and stent patency between stetnt implantation and percutaneous intraductal radiofrquency ablation combined with stent implantation in the treatment of malignant biliary obstruction.[METHODS]1. A retrospective study of stents placed for malignant biliary obstructin (MBO) at Navy General Hospital in the period between June 2012 and December 2013 was conducted. A total of 15 patients with MBO were obtained(7 males and 8 females), the median age was 62 (range,45-81) years.The diagnosis include:six cholangiocarcinoma, three hepatocellular carcinoma and six pancreatic cancer. SEMS implantations for all the 15 patients were conducted.2. A prospective study of percutaneous endobiliary radiofrequency ablation (RFA) combined with stents for MBO at Navy General Hospital in the period between March 2014 and March 2015 was conducted.A total of 10 patients with MBO were obtained (5 males and 5 females), the median age was 59 (range,48-79) years.The diagnosis include:six cholangiocarcinoma, one hepatocellular carcinoma and three pancreatic cancer.Percutaneous transhepatic cholangiography (PTC) were performed in all patients. Patients in SEMS group received stent placement while endobiliary RFA combined SEMS placement were performed for all the 10 patients above.3. Biliary drainage was performed for 2-3 days postoperative and drainage tube was pulled out when dialated bile duct tend to be normal under ultrosound.The serum TBIL, DBIL, ALT and γ-GT preoperative and a week after procedures were compared between the two groups. Monthly reexamination of blood, liver function, renal function, coagulation function were conducted.Abdominal ultrasound/liver enhanced CT/MRI were performed at 3,6,9,12 months respectively. Stent patency rate were compared at 3 months,6 months,9 months and 12 months follow-up.Follow-up were terminated when significantly increased TBIL(>120μ mol/L) or DBIL(>100 μmol/L) or biliary obstruction were confirmed by CT/MRI.4. The data were expressed as the mean±standard deviation of the mean. Two sample Student’s t-Mest and Fisher exact probability test were used for statistical analyses and p<0.05 was considered significant.[RESULTS]1. No significant difference of age, sex and primary disease between the two groups of patients were found (p>0.05). The level of preoperative serum TBIL, DBIL, ALT and y-GT in two groups were statistical analyzed, and no statistical significance was observed (p> 0.05).2. SEMS group:Preoperative serum TBIL was 165.5±27.4μmol/L, decreased to 60.2±23.7μmol/L after one week (t=13.114, p<0.01). Preoperative DBIL changed from 130.2±19.7μmol/L to 46.2±17.9μmol/L (t=12.885,p<0.01) one week later. Preoperative ALT was 125.4±36.9u/L and after one week it dropped to 69.6±28.6 u/L (t=6.895,p<0.01).Preoperative y-GT changed from 385.5± 117.5u/L to 168.5±75.5 u/L (t=6.374, p<0.01) postoperative. Group of percutaneous intraductal RFA combined with SEMS:Preoperative serum TBIL was 143.5±32.0μmol/L, and it dropped to 41.7±15.8μmol/L after one week (t= 11.188, p<0.01). Preoperative DBIL changed from 120.3±29.8μmol/L to 33.9± 12.2μmol/L after one week (t=9.614, p<0.01). Preoperative ALT was 105.07± 23.8u/L, and decreased to 56.2±11.1u/L after one week (t=6.929, p<0.01). Preoperative y-GT was 407.0±169.3u/L, it droped to 193.9± 88.7 u/L postoperative one week (t=4.530, p<0.01). The TBIL, DBIL, ALT and y-GT between two groups of patients showed no significant difference (p> 0.05).3. After three months follow-up, restenosis of biliary with increasing of DBIL was found in two cases in SEMS group. Stent patency was found in remaining 13 patients (86.7%). Biliary obstruction with increasing of DBIL was found in one patient in group of percutaneous endobiliary RFA combined with SEMS.The rate of patency of stent was 90%. No statistic difference of stent patency rate between the two group was obtained (χ2=0.063, p=1.000). Biliary obstruction were found in 8 paitents in the SEMS group while two paitents in the other group at six months follow-up.The patency rate of the two group were 46.7% and 80%. No statistic difference of stent patency rate between the two group was found (χ2=2.778, p=0.211). After nine months follow-up, restenosis of biliary with increasing of DBIL was found in ten cases in SEMS group. Stent patency was found in remaining 5 patients (33.3%). Biliary obstruction with increasing of DBIL was found in two patients in group of percutaneous endobiliary RFA combined with SEMS.The rate of patency of stent was 80%. Statistic difference of stent patency rate between the two group was obtained (χ2=5.235,p=0.041). Biliary obstruction were found in 12 paitents in the SEMS group while three paitents in the other group after twelve months follow-up.The patency rate of the two group were 20% and 70%.Statistc difference of stent patency rate between the two group was obtained (χ2=6.250, p=0.034). Tumor progressions of two groups in varying degrees were observed during follow-up.[CONCLUSION]1. Effctive of relieving jaundice were similar between the two groups in short follow up.No statistic difference in jaundice decreasing was demonstrated between the two groups in 1-3 months follow up.2. When comparing with SEMS placement, endobiliary RFA combined with SEMS can induce partial necrosis of intra-bile duct tumor, therefore, a higher long-term postoperative biliary stent patency rate would be obtained. The method has been proved to be a safe and effective treatment in MBO. |
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