Efficacy and safety of palliative endobiliary radiofrequency ablation using a novel temperature-controlled catheter for malignant biliary stricture: a single-center prospective randomized phase II TRIAL

Kang, Hyun Seung; Chung, Moon Jae; Cho, In Rae; Jo, Jung Hyun; Lee, Hee-Seung; Park, Jeong Youp; Park, Seung Woo; Song, Si Young; Bang, Seungmin

doi:10.1007/s00464-020-07689-z

Cited by 38 publications

(74 citation statements)

References 32 publications

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“…Although endobiliary RFA is a treatment option with a high potential for malignant biliary strictures, there is still no consensus on its utility and safety 1 , 2 . This may be related to the heterogeneity of previous studies, which included differences in the underlying disease, stricture location and status, and/or type of the stent used after RFA 3 – 9 . Moreover, conventional RFA catheters do not achieve effective ablation of strictures that are short, soft, non-tight, or rough due to insufficient contact with the tissue 10 , 11 .…”

Section: Discussionmentioning

confidence: 99%

“…Endobiliary radiofrequency ablation (RFA) is a new adjunctive procedure and promising treatment option for malignant biliary stricture 1 , 2 , which can prolong biliary stent patency and survival time 3 – 7 . However, the efficacy of endobiliary RFA remains controversial, and previous studies have reported conflicting results 8 , 9 , which could be attributed to a limitation of the conventional RFA catheter itself 10 : the ablation effect depends on each lesion’s characteristics, including the stricture length, and the area to be ablated cannot be minutely controlled in the conventional RFA method. Moreover, the safety of the procedure is similarly a concern because RFA cannot be performed under direct observation with ultrasound or endoscopic guidance.…”

Section: Introductionmentioning

confidence: 99%

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Feasibility of balloon-based endobiliary radiofrequency ablation under cholangioscopy guidance in a swine model

Inoue

Kutsumi

Ibusuki

et al. 2021

Sci Rep

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Although endobiliary radiofrequency ablation (RFA) has demonstrated considerable potential for the treatment of biliary strictures, conventional catheter RFA has several limitations. This study aimed to evaluate the feasibility of a novel cholangioscopy (CS)-guided balloon-based RFA procedure in vivo using a swine model. CS-guided balloon-RFA was performed under endoscopic retrograde cholangiography guidance at target temperatures of 60 ℃ or 70 ℃, which were maintained for 60 s. We evaluated the technical feasibility, adverse events, and histological effects associated with the procedure. Twelve sites were ablated in seven miniature pigs. The CS-guided balloon-RFA procedure was technically successful in all cases without any hindrance. Mucosal changes could be detected during RFA, and the ablation area was identified on CS. Necropsy was performed in four pigs on the same day as the procedure: the tissue samples showed coagulative necrosis, and the entire internal circumference of the bile duct was uniformly ablated. The mean lengths of the ablation area in the samples ablated at 60 °C and 70 °C were 20.64 and 22.18 mm, respectively, while the mean depths were 3.46 and 5.07 mm, respectively. The other three pigs were reared and euthanized and autopsied 35 days after the procedure. The site to be ablated had replaced the granulation tissue and fibrotic changes. No adverse events were observed in any case. CS-guided balloon-RFA appears to be a promising option for treating biliary strictures. This preliminary study could pave the way for the evaluation of this procedure in future human clinical trials.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Feasibility of balloon-based endobiliary radiofrequency ablation under cholangioscopy guidance in a swine model

Inoue

Kutsumi

Ibusuki

et al. 2021

Sci Rep

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“…e most commonly reported adverse events of biliary RFA are hemobilia, strictures, liver infarction, pancreatitis, and pseudoaneurysm of the hepatic artery [25]. To avoid unintended thermal damage novelty temperature-controlled RFA systems (ELRA ™ , STARmed Co.) had been studied [26]. ese systems automatically shut down when the temperature reaches the preset target and reactivate the energy delivery to maintain the preset temperature.…”

Section: Discussionmentioning

confidence: 99%

Development of Radiofrequency Ablation Generator and Balloon-Based Catheter for Microendoluminal Thin-Layer Ablation Therapy Using the Rat Duodenum as a Model of Low-Impedance Tissue

Nociarova

Novák

Polàk

et al. 2021

Journal of Healthcare Engineering

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Radiofrequency ablation (RFA) is a routinely used, safe, and effective method for the tissue destruction. Often, in case of its application in malignant conditions, the extent of tissue destruction is insufficient due to the size of the target lesion, as well as due to the risk of heat-induced damage to the surrounding organs. Nevertheless, there are conditions requiring superficial precise-depth ablation with preservation of deeper layers. These are represented, for example, by mucosal resurfacing in case of Barrett’s esophagus or treatment of recurrent mucosal bleeding in case of chronic radiation proctitis. Recently, new indications for intraluminal RFA use emerged, especially in the pancreatobiliary tract. In the case of intraductal use of RFA (e.g., biliary and pancreatic tract), there are currently available rigid and needle tip catheters. An expandable balloon-based RFA catheter suitable for use in such small-diameter tubular organs could be of benefit due to possible increase of contact between the probe and the target tissue; however, to prevent excessive tissue damage, a compatible generator suitable for low-impedance catheter/tissue is essential. This project aimed to develop a radiofrequency ablation generator and bipolar balloon-based catheter optimized for the application in the conditions of low-impedance tissue and (micro)endoluminal environment. Subsequent evaluation of biological effect in vivo was performed using duodenal mucosa in Wistar rat representing conditions of endoluminal radiofrequency ablation of low-impedance tissue. Experiments confirming the safety and feasibility of RFA with our prototype devices were conducted.

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“…In a Korean prospective randomised phase II trial, 48 patients with inoperable malignant biliary strictures were randomly assigned to either an RFA (ID-RFA + uncovered SEMS) or non-RFA (uncovered SEMS only) group. Kang et al 9 showed that the median duration of stent patency, and median overall survival were not different between the groups (132.0 days vs 116.0 days; P = 0.440 and 244.0 days vs 180.0 days; P = 0.281, respectively). To address these conflicting results, additional large-scale randomised studies have recently been conducted.…”

Section: Clinical Efficacy Of Id-rfamentioning

confidence: 96%

“…The optimal ID-RFA settings determined in our studies were 7-10 W for 120 seconds at a target temperature of 80°C. 9 More specifically, according to site in the biliary tract, 7-10 W, 80°C, 120 seconds of ID-RFA is recommended for distal malignant biliary strictures, while 7 W (preferably the short ELRA catheter), 80°C, and 60-120 seconds ID-RFA is advantageous for perihilar malignant biliary strictures. 10,11 The ID-RFA procedure proceeds in the following manner.…”

Section: Principles Of Rfamentioning

confidence: 99%

A review of the recent advances in endoscopic retrograde cholangiography-guided intraductal radiofrequency ablation for malignant biliary strictures

Young

Cho

Jang

et al. 2021

Int J Gastrointest Interv

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Pancreatobiliary malignancy is relatively rare; however, it remains one of the most lethal malignancies and has a dismal prognosis. Endoscopic retrograde cholangiopancreatography (ERCP)-guided intraductal radiofrequency ablation (ID-RFA) is a promising, minimally invasive treatment for unresectable malignant biliary strictures by delivering high-frequency alternating current to the target tissue, leading to coagulative necrosis. Recent studies have provided evidence that ERCP-guided ID-RFA is a safe, well-tolerated, and effective adjunctive treatment in terms of stent patency as well as overall survival. Compared with other local treatments, such as photodynamic therapy, ERCP-guided ID-RFA has advantages, including ease of delivery, controlled application of thermal energy, low cost, and fewer systemic side effects, with an acceptable safety profile. ERCP-guided ID-RFA has been proposed as an attractive endobiliary ablative therapy and is regarded to be an adjuvant method for the palliative care of patients with unresectable malignant biliary strictures. However, due to the ongoing lack of comparative studies, the choice of local ablative therapy remains, in each case, an individual decision by the multidisciplinary team.

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Efficacy and safety of palliative endobiliary radiofrequency ablation using a novel temperature-controlled catheter for malignant biliary stricture: a single-center prospective randomized phase II TRIAL

Cited by 38 publications

References 32 publications

Feasibility of balloon-based endobiliary radiofrequency ablation under cholangioscopy guidance in a swine model

Feasibility of balloon-based endobiliary radiofrequency ablation under cholangioscopy guidance in a swine model

Development of Radiofrequency Ablation Generator and Balloon-Based Catheter for Microendoluminal Thin-Layer Ablation Therapy Using the Rat Duodenum as a Model of Low-Impedance Tissue

A review of the recent advances in endoscopic retrograde cholangiography-guided intraductal radiofrequency ablation for malignant biliary strictures

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