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    Interventional procedure overview of endoscopic bipolar radiofrequency ablation for malignant biliary obstruction

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    Existing assessments of this procedure

    A Health Technology Assessment was carried out by Beyer et al. (2023). This assessment evaluated the clinical effectiveness, cost-effectiveness and potential risks of endoscopic bipolar RFA for MBO, and the value of future research. In this assessment, 68 studies (1,742 people) were included, with 18 comparative studies and 50 non-comparative studies. The majority (53%) of results were conference abstracts with no peer-reviewed published reports. Of the comparative studies, 2 RCTs (Gao 2021; Yang 2018) were peer-reviewed publications and others were conference abstracts, A total of 8 studies were included in meta-analyses.

    The assessment concluded that primary RFA appears to improve survival and is likely to be cost-effective; however, the evidence for this is mainly in people with bile duct cancers rather than in people with pancreatic cancers. Only 6 of 18 comparative studies could be included in the meta-analysis looking at survival because of the differences in outcome measures, but none reported a decrease in survival in the RFA group compared with the stent-only group. There was no increased risk of cholangitis or pancreatitis following RFA, but possibly an increased risk of cholecystitis. There was a lack of high-quality data examining similar outcomes in people having secondary RFA. For both primary and secondary RFAs, there were insufficient data to determine the effect of RFA on quality of life. Recommendations for further research include the following:

    • Prospective RCTs of primary RFA should be conducted, with a specific focus on quality of life and accurate reporting of AEs in each group. People with pancreatic cancers should be classified separately from people with bile duct cancers, to determine the effects of RFA in each group.

    • The mechanism by which primary RFA has a beneficial effect on survival should be explored.

    • Consideration should be given to whether or not a repeat application of RFA at a specified interval may further improve outcomes in people with both pancreatic and bile duct cancers.

    • High-quality prospective RCTs of secondary RFA should be carried out to determine whether or not there is benefit to survival and quality of life, including accurate reporting of AEs. These RCTs should also incorporate an assessment of cost-effectiveness.

    • If benefit is shown in secondary RFA, an exploration of the mechanism should be carried out.

    The British Society of Gastroenterology guidelines for the diagnosis and management of cholangiocarcinoma (Rushbrook et al. 2024) endorse the use of fully covered SEMS given the lower rates of stent dysfunction (21.6% vs 46.8%), lower reintervention rates and better survival rates over plastic stents. Furthermore, for distal obstruction one would use fully covered SEMS rather than uncovered SEMS, which is supported by meta-analysis, despite the small risk of cystic duct obstruction.

    The guidelines recommend that at present the use of adjunctive endobiliary radiofrequency ablation (RFA) and photodynamic therapy is not considered standard of care for patients with hilar and distal CCA having palliative care (strength of recommendation: STRONG; quality of evidence: HIGH). The guidelines further state that adjunctive biliary treatments to improve long-term stent patency and patient survival are not considered standard of care. The application of RFA via either Habib EndoHPB Bipolar Radiofrequency Catheter or the ELRA are designed to cause cancer necrosis while reducing damage to normal biliary mucosa. Complications of RFA include acute pancreatitis, cholangitis, cholecystitis and haemobilia. Likewise, although photodynamic therapy has been reported to increase stent patency, quality of life and survival, 10% of patients incur systemic photosensitivity.