elf-expandable metallic stent (SEMS) placement is an effective treatment for malignant biliary obstruction (1). However, stent restenosis occurs within 6 months in over 50% of patients, due to tumor ingrowth, overgrowth, epithelial hyperplasia, and biliary sludge formation (2, 3). There are no clear recommendations regarding how to reopen SEMS occlusions. Recently, some studies reported the safety and efficacy of a Habib EndoHPB percutaneous radiofrequency ablation (PRFA) catheter for re-opening occluded SEMSs, with a median stent patency time of 102-234 days (4-9).We previously showed that intraluminal brachytherapy (ILBT) with low dose rate (LDR) iodine-125 ( 125 I) seed strands is effective for treatment of malignant biliary obstruction, prolonging stent patency (10,11). To the best of our knowledge, there are no reports regarding the use of PRFA and ILBT synchronously to re-open SEMS occlusions. This study assessed the feasibility and effectiveness of PRFA combined with 125 I seed strand brachytherapy ( 125 I-BT) for the treatment of malignant biliary occlusion after stenting.
MethodsThis study was approved by the Ethics Committee of our hospital (2019-KY-383). All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
PURPOSEWe aimed to assess the effectiveness of percutaneous radiofrequency ablation (PRFA) combined with iodine-125 ( 125 I) seed strand brachytherapy ( 125 I-BT) for treatment of occluded biliary stents.
METHODSFrom November 2015 to September 2017, 13 consecutive patients with occluded biliary metal stents, implanted for malignant obstruction, underwent PRFA combined with 125 I-BT to reopen the bile duct. Data included clinical and technical success, stent patency, complications, and overall survival.
RESULTSThe clinical and technical success rates were both 100%. One month after treatment, the total serum bilirubin level had decreased significantly (p < 0.001). Early complications of cholangitis or hemobilia were experienced by one patient each. Three patients (23.1%) had late complications, including two cases of cholangitis and one case of cholecystitis. During the mean follow-up of 233±82.9 days (range, 88-365 days), the stent patency time was 239±26.5 days (95% CI, 187-291 days), and the 6-month stent patency rate was 68.4%. Five patents died; the mean survival time was 298±30.1 days (95% CI, 239-358 days). The 6-month survival rate was 83%.
CONCLUSIONPRFA therapy combined with 125 I-BT is feasible and safe for patients with occluded metal stents placed for malignant biliary obstruction. Nevertheless, randomized controlled trails are needed to confirm the effectiveness of this new approach.