Novel temperature-controlled RFA probe for treatment of blocked metal biliary stents in patients with pancreaticobiliary cancers: initial experience

Abstract

Background and study aims Radiofrequency ablation (RFA) is used to treat blocked biliary stents in patients with pancreaticobiliary (PB) tumors with varying results. We report our experience with a novel temperature-controlled probe for treatment of blocked metal stents. Patients and methods Patients with histologically proven PB cancers and a blocked biliary stents were treated using ELRATM electrode (Taewoong Medical) under fluoroscopic guidance. Demographics, clinical outcome, stricture diameter improvements, complications and mortality at 30 days were prospectively recorded. Results Nine procedures were performed on seven patients (4 male, 3 female); mean age 65.33 (range 56 – 82 years). Mean stricture diameter prior to RFA was 1.13 mm (SD ± 0.54) and 4.42 mm (SD ± 1.54) following RFA ( P < 0.0001). Five of seven patients (71 %) required additional stents to ensure optimal drainage. There were no procedure-related complications. Mean follow-up was 193.55 days (range 31 – 540) and three of nine patients (33 %) died due to terminal cancer. Conclusion These are the first reported data on use of a temperature-controlled RFA catheter in humans to treat blocked metal biliary stents. The device is safe but further randomized trials are required to establish the efficacy and survival benefits of this probe.

Endoscopic radiofrequency biliary ablation treatment: A comprehensive review

“…Another application of RFA that has been evaluated in two studies is the possibility to ablate tissue in‐growth in occluded SEMS to achieve stent patency as an alternative to the traditional stent‐in‐stent insertion technique. The first study by Kadayifci et al .…”

“…Mean follow‐up period was 194 days (range 31–540 days). Three of the seven patients (42.9%) died as a result of end‐stage malignant disease at 31, 34 and 52 days, respectively, after the RFA procedure …”

“…22 Recently, a randomized controlled trial has been published. 23 Sixty-five patients with types I and II Klatskin tumor (19) or distal cholangiocarcinoma (46) were randomly assigned to RFA plus plastic stent (32) versus plastic stent alone (33). Main outcome was mean survival time that was defined from the time of randomization.…”

“…It is possible to speculate that besides thermal tumor debulking, the immunological response triggered by the tumor necrosis could enhance immunity response directed towards the tumor. [6][7][8][9] TREATMENT OF OCCLUDED SEMS A NOTHER APPLICATION OF RFA that has been evaluated in two studies 32,33 is the possibility to ablate tissue in-growth in occluded SEMS to achieve stent patency as an alternative to the traditional stent-in-stent insertion technique. The first study by Kadayifci et al 32 compared the use of the Habib RFA endoprobe (25) versus plastic stent placement (25) in 50 patients with malignant biliary obstruction.…”

“…Three of the seven patients (42.9%) died as a result of end-stage malignant disease at 31, 34 and 52 days, respectively, after the RFA procedure. 33 Based on the results of these two studies, the role of RFA in patients with occluded SEMS remains uncertain, and a large multicenter study will be necessary to better clarify the rate of AE and the length of stent patency after RFA as compared to stent placement alone. In an in vivo study on three pigs, biliary RFA application was carried out after uncovered biliary SEMS insertion.…”