Cardiovasc Intervent Radiol (2022) 45:873–878

https://doi.org/10.1007/s00270-022-03097-z

TECHNICAL NOTE BILIARY

Percutaneous Endoluminal Radiofrequency Ablation of Occluded

Biliary Metal Stent in Malignancy Using Monopolar Technique:
A Feasibility Study
Tomas Rohan1 • Tomas Andrasina1 • Peter Matkulcik1 • Vladan Bernard2 •

Vlastimil Valek1

Received: 19 October 2021 / Accepted: 8 February 2022 / Published online: 25 February 2022
 Springer Science+Business Media, LLC, part of Springer Nature and the Cardiovascular and Interventional Radiological Society of Europe
(CIRSE) 2022

Abstract stent patency (154 vs. 161 days, p = 0.27). Median cathe-
Purpose To prove feasibility and safety of percutaneous ter-free survival and overall survival after stent recanal-
endoluminal radiofrequency ablation (eRFA) using a ization were 149 and 210 days, respectively.
monopolar approach in treatment of occluded biliary stent Conclusion Endoluminal radiofrequency ablation in
in malignancy. monopolar setting was shown to be a feasible and safe
Materials and Methods The study included 11 patients with method for recanalization of occluded biliary metal stents.
occluded biliary metal stent that had been implanted due to Level of evidence Level 4, Case Series.
malignant biliary obstruction. All underwent metal stent
recanalization by percutaneous eRFA in monopolar setting. Keywords Radiofrequency ablation
Monopolar
Sixteen eRFA procedures were performed under fluoro- technique
Intraductal ablation
Biliary malignancy

scopic guidance with an EndoHPB 8F radiofrequency abla- Biliary stenosis
Metal stent
tion catheter. The effect of stent recanalization was assessed
based upon change from pre- to post-procedural diameter of Abbreviations
the patent lumen of the metal stent (Wilcoxon test), primary SEMS Self-expandable metallic stent
and secondary stent patency (compared by log-rank test), RF Radiofrequency
catheter-free period, and overall survival. Adverse events eRFA Endoluminal radiofrequency ablation
were evaluated according to Common Terminology Criteria CTCAE Common Terminology Criteria for Adverse
for Adverse Events (CTCEA) 4.0. Events
Results Recanalization of the metal stent by monopolar ALT Alanine aminotransferase
radiofrequency ablation was successful in all 11 patients. AST Aspartate aminotransferase
Diameter of the patent lumen of the stent significantly ALP Alkaline phosphatase
widened after the eRFA inside the stent (median 2 vs. GGT Gamma-glutamyl transferase
7 mm, p = 0.003). Grade 1 complications were observed in AMS Amylase
one-third of procedures. Median stent patency after CRP C-reactive protein
recanalization by eRFA was non-inferior to primary metal

& Tomas Andrasina Introduction

andrasina.tomas@fnbrno.cz
1
Biliary stents can be occluded mainly by mucosal prolif-
Department of Radiology and Nuclear Medicine, Faculty of
eration or tumour ingrowth. Radiofrequency (RF) ablation
Medicine, University Hospital Brno, Masaryk University,
Brno 625 00, Czech Republic or laser recanalization can be used to recanalize an
2 occluded biliary self-expandable metallic stent (SEMS)
Department of Biophysics, Faculty of Medicine, Masaryk
University, Brno 625 00, Czech Republic [1, 2]. RF ablation can be applied percutaneously or

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endoscopically using monopolar or bipolar technique
[3–6]. The catheter recanalization technique is not pre-
cisely described in previous literature [1], however, and the
optimal effect cannot be achieved in all cases due to the
disproportion size of the catheter relative to the occluded
stent. Although bipolar technology is more effective
in vitro and is capable of producing higher temperatures in
shorter time [7], conductivity-dependent RF ablation in a
metal stent could lead to thermal damage to healthy bile
ducts and possible catheter failure in case of short circuit
between the electrodes and mesh of the SEMS [5, 8].
These limitations can be avoided using monopolar
technique. The monopolar technique of endoluminal abla-
tion has been tested in the liver environment and in the
presence of SEMS in ex vivo thermographic studies [5].
The aim of this study was to demonstrate feasibility and
safety of endoluminal radiofrequency ablation (eRFA) in
monopolar mode when treating biliary metal stent
occlusion.
inside the stenotic or occluded biliary SEMS and second
upon the time to reocclusion of the stent. Figure 1. Dif-
ferences in SEMS patency rate since initial insertion and
since recanalization by monopolar RF ablation and in
catheter-free period were evaluated. Furthermore, overall
survival since initial biliary drainage, since biliary SEMS
insertion, and since biliary SEMS recanalization by
monopolar RFA was observed. Definitions and monitored
parameters are described in ‘‘Appendix A’’.
Safety assessment included identification and grading of
complications according to CTCAE (Common Terminol-
ogy Criteria for Adverse Events) Version 4.0 based upon
regular clinical and laboratory examinations and imaging
methods. Pre- and post-procedural levels of bilirubin, ala-
nine aminotransferase (ALT), aspartate aminotransferase
(AST), alkaline phosphatase (ALP), gamma-glutamyl
transferase (GGT), amylase (AMS), and C-reactive protein
(CRP) taken within 24 h before the procedure and within
24–48 h after the procedure were compared.

Materials and Methods
Study Population
Eleven patients were enrolled in the study between 2009
and 2019. All were selected based upon the indication
criteria for percutaneous recanalization of occluded biliary
SEMS in our hospital (Table 1). Table 2 summarizes basic
characteristics of the patients.
Outcome Measure
The effect of eRFA was evaluated first based upon change
from pre- to post-procedural diameter of the patent lumen
Technique of eRFA
The procedure was performed with moderate sedation and
appropriate monitoring. An EndoHPB RF ablation catheter
(8F, 180 cm, HabibTM EndoHPB; Boston Scientific; for-
merly EMcision Ltd) connected to a model 1500 RF gen-
erator (AngioDynamics, Latham, NY, USA) working at
frequency 460 kHz ± 5% was used [1]. The distal elec-
trode of the ablation catheter worked as the active electrode
during treatment and the disperse electrode was located on
the patient’s back. The RF catheter was introduced per-
cutaneously into an occluded biliary stent under fluoro-
scopic control via a 9–10 F sheath. The distal electrode was
positioned to the occluded part of the stent. In the generator
output setting, Bernard’s recommendations from an ex vivo

Table 1 Inclusion and Inclusion criteria

exclusion criteria of the study
Histologically verified malignant stenosis of bile ducts
Failure of endoscopic biliary drainage
Percutaneously implanted uncovered biliary metal stent
Occlusion of percutaneously implanted biliary metal stent
Successful percutaneous drainage of the biliary tract through the occluded biliary metal stent
Signed informed consent

Exclusion criteria

Liver or renal failure (serum albumin B 35 g/L; serum creatinine C 200 lmol/L)
International normalized ratio C 1.3
Presence of a pacemaker
Relative: Karnofsky performance status \ 80%
Relative: Life expectancy \ 3 months

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R. Tomas et al.: Percutaneous Endoluminal Radiofrequency Ablation… 875

Table 2 Basic characteristics of patients session. Some patients underwent multiple ablation ses-
Median (range) Mean ± SD
sions depending upon evidence of successful recanalization
on cholangiography. The percutaneous plastic drain was
Age (years) 63.6 (36.2–79.5) 63.6 ± 11.1 definitively extracted after the last eRFA session.
Number %
Follow-Up
Female 5 45
Diagnosis The patients enrolled in the study received standard
Cholangiocarcinoma 8 73 oncological treatment based upon decision of the Mul-
Pancreatic carcinoma 1 9 tidisciplinary Tumour Board. After discharge from hospital
Metastasis of colorectal carcinoma 1 9 in the absence of clinical symptoms, follow-up included
Duodenal carcinoma 1 9 liver ultrasound and blood tests every 3 months. Patients
Classification of obstruction (Bismuth-Corlette) were followed until their deaths.
I / common bile duct 2 18
II 2 18 Statistical Analysis
IIIa 1 9
IIIb 3 27 Standard statistics were used in the descriptive analysis of
IV 3 27 patients. Categorical variables were described by absolute
Brachytherapy 8 72 and relative frequencies. The level of statistical signifi-
cance in all analyses was set at p = 0.05. Analyses were
Median (range) Mean ± SD
performed using IBM SPSS Statistics 23 (IBM Corpora-
Length of obstruction (cm) 5.0 (2.0–8.0) 5.1 ± 2.0 tion, Armonk, NY, USA).
Number of metal stents 2 (1–3) 1.8 ± 0.7

Results

Sixteen sessions of eRFA in the occluded uncovered SEMS

experiment were followed and 10–30 W was applied [5].
using monopolar technique in histologically proven
The particular RF ablation protocol depended upon a
malignant biliary stenosis were performed in 11 patients (5
periprocedural measuring of the impedance and visualiza-
women, 6 men), average age 65 (median 63, range 40–79)
tion of the ablated stenosis on periprocedural cholangiog-
years. Mean time to primary stent occlusion or severe in-
raphy with iodine contrast (Iomeron 300, Bracco, Milano,
stent restenosis was 286 ± 298 (median 161, range
Italy) as described in ‘‘Appendix B’’. Finally, a percuta-
93–1185) days.
neous plastic drain was introduced after each ablation

Fig. 1 Percutaneous
transhepatic cholangiography.
A Dilatation of the biliary tract
due to an occluded biliary metal
stent before recanalization.
B Endoluminal RFA in
monopolar setting inside the
biliary metal stent (arrows
indicate the eRFA catheter,
arrowhead indicates the active
electrode). C Control
cholangiography after biliary
metal stent recanalization by
monopolar RFA

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Efficacy of eRFA in Metal Stent
For eRFA, generator power ranging from 10 to 30 W
(median 10 W) for 2–12 min (median 6.5 min) was used
for 1 to 3 treatments (1 in seven patients, 2 in three
patients, and 3 in one patient) in a single occluded SEMS.
Median diameter of the occluded or stenotic lumen
increased from 2 mm (range 0–4 mm) to 7 mm (range
5–10 mm) (p = 0.003, Fig. 2). Reocclusion of the stent
occurred in seven patients in mean 105.5 ± 58 days (me-
dian 80.5; range 38–189 days). Four patients died without
evidence of stent occlusion’s recurrence in 77, 184, 243,
and 823 days after the procedure. In two patients in good
general condition, eRFA was performed even after subse-
quent reocclusion of the stent, but percutaneous plastic
drain remained placed in the biliary tract despite successful
treatment afterwards.
In summary, biliary stent patency after eRFA in the
study group was mean 192 ± 209 days (median 154, range
38–823 days) and catheter-free period 178 ± 211 days
(median 149, range 36–816 days). Patency 30, 90, 180,
270, and 365 days after the recanalization of the SEMS
was 100%, 64%, 36%, 9%, and 9%, respectively. The
difference between primary stent patency and stent patency
after recanalization by eRFA was not significant (median
161 vs. 154 days, p = 0.27).
Mean time to death after percutaneous SEMS insertion
was 623 ± 470 days (median 462, range 289–1875). Mean
time to death after eRFA was 320 ± 239 days (median
210, range 77–823 days) (Table 3). Survival 30, 90, 180,
270, and 365 days after the metal recanalization was 100%,
91%, 73%, 36%, and 27%, respectively.
10
8
diameter (mm)
6 stent on its convexity. To make contact with the stent wall
4 Using radiofrequency ablation in this catheter position, the
2 on the convex surface. This problem could potentially be
0 catheter, which would fill the entire lumen of the SEMS
before ablation after ablation
Fig. 2 Box-plot demonstrating diameter of patent lumen inside metal
stent before and after endoluminal RFA in monopolar mode (median
2 vs. 7 mm, p = 0.003)
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Safety of eRFA in a Metal Stent
Grade I complications (CTCEA 4.0) were observed during
and after ablation in six procedures (33%, 1 mild nausea, 2
mild pain, 1 temporary fever, and 2 mild haemobilia). No
complications of grades 2–5 were reported. Changes in pre-
and post-procedural bilirubin, ALT, AST, ALP, GGT, and
CRP were not significant (p = 0.07–1.00) (Table 4).
Discussion
This pilot study indicated precise eRFA in a monopolar
mode to be a feasible method for recanalization of the
occluded SEMS, albeit with possible minor complications.
Stent recanalization resulted in median SEMS patency of
154 days and catheter-free period of 149 days. By contrast,
stent patency after eRFA using bipolar connection is
reported as 84.5–149 days [1, 6, 9]. Surprisingly, SEMS
patency after recanalization by monopolar RFA was non-
inferior to the primary SEMS patency (median 154 vs.
161 days, p = 0.27). The median survival after biliary stent
recanalization by monopolar RFA reached 210 days (range
77–823 days), which is superior to 80.5 days after bipolar
RFA reported in the literature [10].
Because eRFA is a debulking technique without curative
potential, it does not prevent further tumour growth that
may cause reocclusion of the SEMS. This occurred in 7 of
11 patients. The benefit of eRFA consists in its ability to
clear an obstructed SEMS and avoid long-term need for
internal–external drains, which is associated with signifi-
cant complications and deteriorated quality of life.
Furthermore, eRFA using both bipolar and monopolar
techniques has a number of technical limitations. The same
8F catheter is used for recanalization of biliary stent with
diameter 8–10 mm in both methods. Due to the RFA
catheter’s disproportionate size relative to the SEMS
diameter, it is challenging to perform RFA covering the
whole area of the stent. Another problem is bending of the
RFA catheter, which follows the shape of the biliary tract.
The catheter is mostly in contact with biliary tract wall or
on the catheter’s concavity is technically very difficult.
tissue at the concave end of the catheter is heated less than
solved by using a balloon expandable radiofrequency
[11]. Due to risk of thermal damage to surrounding healthy
tissues, recanalization of SEMS may be performed in
future using an expandable irreversible electroporation
catheter, which offers minimal risk of thermal injury and
benefits of continuously monitoring electrical parameters
R. Tomas et al.: Percutaneous Endoluminal Radiofrequency Ablation… 877

Table 3 Survival and metal Median (range) Mean ± SD p value

stent patency rate (days) before
and after recanalization Survival since initial drainage 581 (372–2090) 733 ± 498 –
Survival since initial stent insertion 462 (289–1875) 623 ± 470
Survival since stent recanalization 210 (77–823) 320 ± 239
Primary stent patency 161 (92–1178) 284 ± 298 0.27
Stent patency/death after recanalization 154 (38–823) 192 ± 209

Table 4 Pre- and post- Pre-procedural Post-procedural p value

procedural values of liver
enzymes, bilirubin, and Median (range) Mean ± SD Median (range) Mean ± SD
C-reactive protein
Bilirubin (lmol/L) 64.3 (8.5–232) 72.9 ± 64.3 27.5 (6.3–90) 38.5 ± 28.3 0.071
ALT (lkat/L) 0.57 (0.26–0.94) 0.60 ± 0.25 0.695 (0.29–1.23) 0.74 ± 0.27 0.238
AST (lkat/L) 0.635 (0.18–1.6) 0.80 ± 0.51 0.745 (0.19–1.96) 0.91 ± 0.56 0.208
GGT (lkat/L) 3.31 (1.39–30.88) 7.54 ± 9.41 4.755 (1.42–13.3) 5.92 ± 4.23 1.000
ALP (lkat/L) 6.38 (1.34–22.59) 7.68 ± 6.48 6.475 (1.23–19.1) 7.69 ± 5.54 0.779
AMS (lkat/L) 0.765 (0.33–1.15) 0.73 ± 0.29 0.675 (0.46–1.03) 0.72 ± 0.21 0.779
CRP (mg/L) 21.3 (13.4–49.7) 26.4 ± 12.9 35.5 (3.2–145.6) 49.2 ± 40.0 0.208
ALP alkaline phosphatase, ALT alanine aminotransferase, AMS amylase, AST aspartate aminotransferase,
CRP C-reactive protein, GGT gamma-glutamyltransferase

and mapping the extent of stenosis during irreversible
electroporation [12].
This study has several limitations. The results should be
interpreted with caution because of the small, selected
study population with different types of malignancies and
no control group. The histological nature of the tissue
occluding the stents was not analysed. To assess the true
effect on patency rate, survival, and quality of life, future
randomized trials are needed comparing monopolar and
bipolar RFA, as well as other possible options for SEMS
recanalization. Further, multicentric studies are needed due
to the lack of standardized ablation protocol (duration,
endpoints, power setting).
Conclusion
(ultrasound and CT), then finally confirmed by percuta-
neous cholangiography. Biliary metal stent patency after
endobiliary recanalization by RFA was defined as the time
until biochemical or clinical evidence of obstructive jaun-
dice or the time until new or progressing biliary tract
dilatation or death of the patient. Pre-procedural diameter
of stenotic bile ducts in the stent was measured on
cholangiogram after percutaneous puncture of bile ducts
before passing the stenosis with a plastic drain. In the case
of complete stent occlusion, diameter of 0 mm was
recorded. Post-procedural diameter of the ablated bile duct
was measured on cholangiogram 2 days after the last ses-
sion of eRFA in two unidentical projections (e.g. antero-
posterior and oblique views). The length of the stenosis
was measured as the length of an irregular contour of the
stenotic bile duct.

Endoluminal radiofrequency ablation in monopolar setting

appears to be a feasible and safe method for recanalization
of occluded SEMS. It remains unclear whether the tech-
nique of endoluminal RFA is the best way to resolve biliary
SEMS occlusion.
Appendix A: Definitions and Monitored
Parameters
Stenosis or occlusion of the metal stent was diagnosed
based upon elevated obstructive liver enzymes, elevated
bilirubin, and dilated bile ductus on imaging methods
Appendix B: Detailed Description of the RF
Ablation Procedure
The endpoint of each RF ablation procedure was to develop
coagulative necrosis with charring. This was determined by
rapid increase in impedance or reaching the maximum time
of the RF ablation of 10 min at 10 W. If the ablation
process did not lead to the intended result (i.e. increase in
impedance), ablation in the same location was performed at
30 W for a maximum of 2 min. After each RF ablation, the
catheter was removed, inspected for presence of debris and
burnt tissue, then properly cleaned. Depending upon the

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length of the stricture, sequential applications of RF abla-
tion were applied to ensure treatment of the full length of
the stricture and with an overlap of treated areas. After the
whole ablation procedure, balloon dilatation to clear the
tumour fragments and debris was performed using a bal-
loon of nominal diameter identical to the diameter of the
stent. Patients underwent multiple sessions of ablation
depending upon the evidence of successful recanalization
on cholangiography. If there was no sign of restenosis on
cholangiography at average 1 week after the last session of
eRFA, external–internal drains were replaced by safety
catheter. In the case of no clinical and laboratory deterio-
ration, safety catheter was extracted after another week. In
case of unsatisfactory cholangiography (i.e. persistent stent
obstruction or in-stent stenosis 7 days after the initial
procedure), eRFA was repeated.
It must be pointed out that when using the RITA 1500
generator, the distal electrode is active in the monopolar
ablation. The proximal electrode is active when using the
1500X type (not investigated in the study).
Acknowledgements Funding was provided by Ministry of Health of
the Czech Republic (Grant No. NU21-08-00561).
Declarations
Conflict of interest All authors declare that they have no conflict of
interest.
Consent for Publication Consent for publication is not required for
this type of study.
Ethical Standards Approval of the Institutional Ethics Committee of
the University Hospital Brno for this randomized study was granted
on 17 December 2009 (#MZ10-FNB-VV). All procedures performed
in studies involving human participants were in accordance with the
ethical standards of the institutional and/or national research com-
mittee and with the 1964 Helsinki declaration and its later amend-
ments or comparable ethical standards.
Informed Consent Informed consent was obtained from all indi-
vidual participants included in the study.
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R. Tomas et al.: Percutaneous Endoluminal Radiofrequency Ablation…
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