Endoscopic biliary radiofrequency ablation (RFA) may be an option for the treatment
of ingrowth occlusion after self-expandable metal stent (SEMS) deployment; however,
its utility remains uncertain. This study aimed to examine the feasibility of RFA
for the palliation of ingrowth after bilateral SEMS placement in patients with malignant
hilar biliary obstruction.
This prospective, single-center, pilot study enrolled 30 patients who met the eligibility
criteria between April 2020 and March 2022. The study outcomes included technical
success, clinical success, recurrent biliary obstruction (RBO), and adverse events
(AE) besides RBO associated with RFA for ingrowth occlusion. Furthermore, the factors
predictive of clinical success were evaluated.
The technical and clinical success rates were 93.3% (28/30) and 71.4% (20/28), respectively.
The rates of early and late AEs were 6.7% (2/30) and 10.0% (2/20), respectively. The
incidence rate of RBO after RFA was 45.0% (9/20), and the median time to RBO was 163
days. Multivariate analysis of the factors affecting clinical success revealed a positive
association between the recanalization diameter on the ingrown part within the SEMS
(odds ratio, 1.13; 95% confidence interval, 1.01-1.26; P=0.038). The calculated optimal
cutoff for the ratio of the recanalization diameter to the SEMS diameter for predicting
clinical success was 51.1%.
Endoscopic biliary RFA elicited promising results, with good long-term stent patency
and without the requirement of any additional stent placement, for the palliation
of ingrowth occlusion after bilateral SEMS placement. However, the clinical success
rate was insufficient, necessitating improvements in the future.
Received in revised form:
Publication stageIn Press Journal Pre-Proof
Statement of Ethics: The institutional review board of Aichi Medical University Hospital approved this study (approval number: 2019-202), which was conducted in accordance with the principles of the Declaration of Helsinki.
Disclosure Statement: Tadahisa Inoue received honoraria from Boston Scientific Japan and Japan Lifeline Co., Ltd, outside the submitted work. The other authors disclose no financial relationships relevant to this publication.
Funding Sources: This study did not receive funding from any source.
Tadahisa Inoue: conception and design, data acquisition, analysis and interpretation, and drafting and revision of the manuscript
Mayu Ibusuki, Rena Kitano, Kazumasa Sakamoto, Satoshi Kimoto, Yuji Kobayashi, Yoshio Sumida, Yukiomi Nakade, Kiyoaki Ito, and Masashi Yoneda: data interpretation, and revision of the manuscript
© 2022 by the American Society for Gastrointestinal Endoscopy