Efficacy and Safety of Radiofrequency Ablation Plus Stent Versus Stent-alone Treatments for Malignant Biliary Strictures

Abstract

Background/Aims: Malignant biliary strictures (MBS) are very aggressive and cannot be diagnosed in the early stages due to their asymptomatic nature. Stenting the stricture area of the biliary tree is palliative treatment but has poor survival time. Radiofrequency ablation plus stent (RFA+S) have been recently used to improve the survival and stent patency time in patients with MBS. In this systematic review and meta-analysis, we tried to evaluate the efficacy and safety of radiofrequency ablation. Materials and Methods: Study search up to December 2021 was performed in different medical databases such as PubMed, Web of Science, and Cochrane library, etc. We selected eligible studies reporting survival time, stent patency time, and adverse events in patients with MBS. We compare the outcomes of RFA+S and stent-alone treatment groups. Results: A total of 15 studies (6 randomized controlled trials and 9 observational studies) with 1815 patients were included for meta-analysis of which 701 patients were in RFA+S group and 1114 patients in the stent-alone group. Pooled mean difference of survival time was 2.88 months (95% CI: 1.78-3.97) and pooled mean difference of stent patency time was 2.11 months (95% CI: 0.91-3.30) and clinical success risk ratio was 1.05 (95% CI: 1.01–1.09). Risk ratios for adverse events are given; Bleeding 0.84 (95% CI: 0.34-2.11), abdominal pain 1.06 (95% CI: 0.79-1.40), pancreatitis 0.93 (95% CI: 0.43-2.01), cholangitis 1.07 (95% CI: 0.72-1.59), and stent dysfunction 0.87 (95% CI: 0.70-1.07). Conclusions: Radiofrequency ablation is involved in increased survival and stent patency time for MBS patients. With the help of better techniques, adverse events can be limited.

Intraductal radiofrequency ablation plus biliary stent versus stent alone for malignant biliary obstruction: a systematic review and meta-analysis

“…These factors are critically important to accurately assess stent patency, especially when studying such a heterogeneous population. Another meta-analysis included duplicate data, which also limited interpretability of the results [30]. Our current systematic and metaanalysis is strengthen by including only RCTs, and thus, presents the highest evidence level.…”

“…Four previous meta-analyses have investigated stent patency comparing groups with and without RFA; however, there have been discrepant results [27][28][29][30]. In these prior meta-analyses, most eligible studies were observational or retrospective; there were few numbers of RCTs, and limited data regarding type of stent utilized, treatment route (endoscopic or percutaneous), tumor location, and etiology of MBO.…”

Consensus statements on endoscopic radiofrequency ablation for malignant biliary strictures

“…Several meta-analyses have confirmed that RFA does not increase the additional risk of adverse events compared to conventional ERCP. [32][33][34][35]61 However, it may still lead to certain complications; therefore, sufficient attention should be paid to and active prevention and treatment should be taken for high-risk patients.…”

“…34 In a meta-analysis, there was no statistical difference in the occurrence of abdominal pain between the RFA group and the stenting alone group (risk ratio [RR] 1.06, 95% CI 0.79-1.40, P = 0.71). 61 Generally, abdominal pain lasts for 1-5 days and can be relieved spontaneously, and analgesics can be given when necessary. Other rare complications include partial liver infarction, 68 biliary duct perforation, 69 liver abscess, 23 and bile leakage, 63 which are related to the thermal effect of RFA that affects local blood vessels as well as deep tissue damage.…”

“…The incidences of complications in endobiliary RFA have been reported to range from 4.2% to 35%, including pancreatitis, cholangitis, cholecystitis, ampullary stenosis, and bleeding, 34,61 which are closely associated with the ERCP procedure, biliary drainage, tumor location, and the anatomical relationship with the adjacent organs. Several meta‐analyses have confirmed that RFA does not increase the additional risk of adverse events compared to conventional ERCP 32–35,61 . However, it may still lead to certain complications; therefore, sufficient attention should be paid to and active prevention and treatment should be taken for high‐risk patients.…”