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Radiofrequency ablation in the management of Barrett’s esophagus – preliminary own experience

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Barrett's esophagus develops as a result of chronic injury of esophagus epithelium from gastroesophageal reflux disease. It is defined when metaplastic columnar epithelium replaces the stratified squamous epithelium which normally lies in the distal esophagus. The condition represents a risk factor for esophageal adenocarcinoma. The aim of the radiofrequency ablation (RFA) method is to destroy metaplastic epithelium with radiofrequency electric current and to stimulate reappearance of the flat multilayer epithelium in the distal esophagus. To evaluate the efficiency and safety of the RFA technique, newly introduced in Poland, in the management of Barrett's esophagus. Twelve patients were treated with the RFA method. Patients with Barrett's esophagus confirmed in the histopathological report were qualified for treatment. Two RFA techniques were applied using a BARRX(®) device: circular based on the balloon HALO(360) system or focal based on the HALO(90) system mounted to the endoscopic ending. The procedures were performed at 2-month intervals. The macroscopic and microscopic effects of RFA therapy, the patients' treatment tolerance as well as potential complications were evaluated. In the group of 12 patients subjected to RFA therapy, 10 completed the therapeutic cycle. A total of 37 procedures were performed: 5 HALO(360) and 32 HALO(90). In all patients eradication of the abnormal metaplastic esophageal epithelium was achieved, as confirmed in both endoscopic and histopathological evaluation. In 2 patients with ongoing therapy progressive eradication of metaplastic epithelium was observed. No significant RFA-related complications were reported. Based on our preliminary results we consider this method to be promising, free of significant complications and well tolerated by patients. In most patients it results in successful eradication of metaplastic epithelium in the distal esophagus.
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Videosurgery and Other Miniinvasive Techniques 2, June/2013
107
Radiofrequency ablation in the management of Barrett’s esophagus
– preliminary own experience
WWoojjcciieecchh PP.. DDąąbbrroowwsskkii,, AAnnddrrzzeejj BB.. SSzzcczzeeppaanniikk,, AAnnddrrzzeejj MMiissiiaakk,, KKoonnrraadd PPiieellaacciińńsskkii
Department of General and Hematological Surgery, Institute of Hematology and Transfusion Medicine, Warsaw, Poland
Videosurgery Miniinv 2013; 8 (2): 107-111
DOI: 10.5114/wiitm.2011.32807
A b s t r a c t
IInnttrroodduuccttiioonn::
Barrett’s esophagus develops as a result of chronic injury of esophagus epithelium from gastroe-
sophageal reflux disease. It is defined when metaplastic columnar epithelium replaces the stratified squamous epithe-
lium which normally lies in the distal esophagus. The condition represents a risk factor for esophageal adenocarcino-
ma. The aim of the radiofrequency ablation (RFA) method is to destroy metaplastic epithelium with radiofrequency
electric current and to stimulate reappearance of the flat multilayer epithelium in the distal esophagus.
AAiimm::
To evaluate the efficiency and safety of the RFA technique, newly introduced in Poland, in the management of
Barrett's esophagus.
MMaatteerriiaall aanndd mmeetthhooddss::
Twelve patients were treated with the RFA method. Patients with Barrett's esophagus con-
firmed in the histopathological report were qualified for treatment. Two RFA techniques were applied using a BARRX®
device: circular based on the balloon HALO
360
system or focal based on the HALO
90
system mounted to the endo-
scopic ending. The procedures were performed at 2-month intervals. The macroscopic and microscopic effects of RFA
therapy, the patients’ treatment tolerance as well as potential complications were evaluated.
RReessuullttss::
In the group of 12 patients subjected to RFA therapy, 10 completed the therapeutic cycle. A total of 37 proce-
dures were performed: 5 HALO
360
and 32 HALO
90
. In all patients eradication of the abnormal metaplastic esophageal
epithelium was achieved, as confirmed in both endoscopic and histopathological evaluation. In 2 patients with ongo-
ing therapy progressive eradication of metaplastic epithelium was observed. No significant RFA-related complications
were reported.
CCoonncclluussiioonnss::
Based on our preliminary results we consider this method to be promising, free of significant complica-
tions and well tolerated by patients. In most patients it results in successful eradication of metaplastic epithelium in
the distal esophagus.
KKeeyy wwoorrddss::
Barrett’s esophagus, metaplasia, radiofrequency ablation.
Original paper
Address for correspondence
Wojciech Dąbrowski MD, Department of General and Hematological Surgery, Institute of Hematology and Transfusion Medicine,
14 Indiry Gandhi St, 02-776 Warsaw, Poland, phone: +48 22 34 96 271, fax: +48 22 34 96 272, e-mail: wdwawa@poczta.onet.pl
Videosurgery
Introduction
Barrett’s esophagus (BE) develops as a result of
chronic injury of esophagus epithelium from acid gas-
tric content in the course of gastroesophageal reflux
disease. Barrett’s esophagus is defined when meta-
plastic columnar epithelium replaces the stratified
squamous epithelium which normally lies in the dis-
tal esophagus. The condition represents a risk factor
for esophageal adenocarcinoma. World statistics on
the incidence of BE in the general population are
divergent and vary between 0.9% and 6% [1]. The
annual incidence rate of adenocarcinoma in patients
with BE is estimated at 0.5% [2]. The rise in incidence
Videosurgery and Other Miniinvasive Techniques 2, June/2013
108
rate for esophageal adenocarcinoma is nowadays the
highest among different types of carcinomas [3]. In
the United States its incidence, estimated as 4% in
the 1970s, increased to 60% during the last thirty
years [3]. Due to unsatisfactory Barrett’s metaplasia
recognition and the steadily growing number of new-
ly diagnosed esophageal adenocarcinoma cases, this
group of patients is steadily becoming the focus of
attention.
During the last years several new methods for
eradication of metaplastic epithelium in the distal
esophagus have been developed. The most frequent-
ly applied methods are argon beam therapy, endo-
scopic mucosal resection, submucosal resection, cryo -
therapy, photodynamic therapy and, most recently
introduced, radiofrequency ablation [4-7]. In this last
method a radiofrequency electric current is applied to
destroy metaplastic or dysplastic epithelium and to
stimulate the process of flat multilayer epithelium
reappearance [8].
Aim
The aim of the study was to evaluate the efficacy
and safety of the radiofrequency ablation (RFA) me -
thod, newly introduced in Poland, for the manage-
ment of BE.
Material and methods
Twelve patients (10 men, 2 women) aged 45-75
(av erage: 58.1 years) were treated with the RFA meth -
od in the period July 2010 – December 2011. Gastroe-
sophageal reflux disease was diagnosed in all pa -
tients and sliding hiatus hernia in eight (7 men,
1 woman). Criteria for enrolment for Halo therapy
were Barrett nondysplastic metaplasia, low grade dys-
plasia (LGD) or high-grade dysplasia (HGD) confirmed
in histopathological reports. We also included 1 pa -
tient after endoscopic mucosal resection due to
esophageal adenocarcinoma in situ. Radical excision
with endoscopic mucosal resection was confirmed by
histological evidence and endoscopic ultrasound
investigation. Patients with esophagus mucosal in -
juries were disqualified but re-qualified after the le -
sions were cured.
Prior to therapy biopsy specimens were collected
from all patients at 1 cm distance from four quad-
rants of the esophagus. Lesions were evaluated ac -
cording to the Prague classification [9]. The proce-
dures were applied in cycles at 2-month intervals
under general anesthesia or intravenous premedica-
tion using the Halo device produced by BARRX
Medical
®
(Sunnyvale, California, USA). Two RFA tech-
niques were used depending on the type and loca-
tion of metaplastic changes: circumferential or focal.
The circumferential method based on a balloon sys-
tem (HALO
3
60
) was used for circular, metaplastic
lesions on large surfaces, while the focal method
based on the HALO
90
system mounted on the endo-
scopic ending was used for smaller focal lesions.
Radiofrequency energy was supplied to the tissue via
a bipolar electrode; 12 J/cm
2
was applied for dysplas-
tic lesions while 10 J/cm
2
was applied for intestinal
metaplasia. The depth of ablative damage involved all
the mucosa and the superficial part of submucosa.
Not more than two HALO
360
and three HALO
90
proce-
dures were performed per patient.
On the procedure day and during the next 24 h
the patients were intravenously administered 40 mg
of omeprazole every 12 h and from the second day
on they were given oral proton-pump inhibitors (PPI)
doses of 40 mg twice a day. On the procedure day
the patients were administered fluids intravenously
and a liquid diet was given for the next 2 days. After
therapy all patients were subjected to 1-month
endoscopic follow-up combined with histopatholog-
ical examination. Macroscopic and microscopic effects
of RFA were evaluated as well as patients’ tolerance
of the procedure and possible complications. Control
examinations were supplemented by endoscopic
evaluation with a narrow band imaging (NBI) sys-
tem. Once the endoscopic treatment was completed
patients were qualified for laparoscopic antireflux
surgery. Four of them (4/11) expressed consent and
were subjected to laparoscopic fundoplication with
Nissen’s method [10, 11]. After the treatment course
all patients were subjected to annual endoscopic
and histopathological follow-up.
Results
In 10 of the 12 patients the treatment cycle was
completed. The patients were subjected to a total of
37 procedures: 5 with HALO
360
and 32 with HALO
90
.
Prior to treatment BE nondysplastic metaplasia was
diagnosed in 5 patients, LGD in 5 and HGD in 2 pa -
tients. The abnormal metaplastic esophageal epithe-
lium was eradicated in all cases as confirmed in both
the endoscopic and histopathological report. In 2 pa -
Wojciech P. Dąbrowski, Andrzej B. Szczepanik, Andrzej Misiak, Konrad Pielaciński
Videosurgery and Other Miniinvasive Techniques 2, June/2013
109
Radiofrequency ablation in the management of Barrett’s esophagus – preliminary own experience
tients with ongoing treatment the metaplastic epi -
thelium was gradually eliminated. Two to five proce-
dures (average: 3.5) were required to achieve squa-
mous epithelium reappearance. Treatment duration
ranged from 3 to 12 months (average: 6.4 months).
No complications related to the RFA procedure were
reported, which on the whole was well tolerated with
only some epigastric and thoracic discomfort ob -
served up to 12 h following the procedure. In 1 pa tient
a minor focus of adenocarcinoma in the gastro-
esophageal junction 12 months after successful com-
pletion of treatment was discovered. The carcinoma
texture was located below the normal epithelium.
Endoscopic mucosal resection was performed. As
a result of invasive cancer detected in histopatholog-
ical examination the patient was qualified later for
surgical resection.
Discussion
To date there are no univocal, consistent recom-
mendations for the treatment of BE [12]. Despite the
growing interest in the management of this condition
in most countries the only recommendation for pa -
tients with BE is endoscopic surveillance with the aim
of early recognition of cancer. The frequency of endo-
scopic follow-up depends on the type of lesions
determined in histopathological examination. For iso-
lated metaplasia endoscopy with biopsy is recom-
mended every 2 years, for LGD every year and for HGD
every 3-6 months [13]. Some authors also recom-
mend resection procedures for patients with HGD.
Numerous endoscopic and surgical methods of ab -
normal epithelium removal are currently being develop -
ed [12]. Antireflux surgery as prophylaxis against
PPhhoottoo 11..
Barrett's esophagus; metaplastic epi -
thelium focal areas visible in the lower part of
the esophagus
PPhhoottoo 22..
Therapy with BARRX
®
HALO
90
method
PPhhoottoo 33..
Endoscopic image after RFA treatment
PPhhoottoo 44..
NBI endoscopic image after RFA treat-
ment
Videosurgery and Other Miniinvasive Techniques 2, June/2013
110
6
5
4
3
2
1
0
CC00MM22 CC00MM22 CC22MM55 CC00MM22 CC00MM22 CC55MM77 CC44MM55 CC00MM22 CC33MM55 CC33MM55
Prague classification: C – circumference (cm), M – maximal extent (cm)
FFiigguurree 11..
Number of HALO BARRX
®
procedures performed in consecutive patients according to Prague clas-
sification
Wojciech P. Dąbrowski, Andrzej B. Szczepanik, Andrzej Misiak, Konrad Pielaciński
reflux of gastric contents eliminates the underlying
cause of BE [12, 14]. In some patients however the
metaplastic or dysplastic lesions persist and may
lead to development of adenocarcinoma. According
to some authors [14] these procedures should be
combined with procedures applied for eradication of
abnormal glandular epithelium such as argon coagu-
lation or radiofrequency ablation. Following success-
ful RFA 4 of our patients were subjected to antireflux
surgery with good outcome.
Radiofrequency ablation is one of the most recent
methods for management of BE. Data obtained from
large clinical trials [13, 15] show this method to be
92% effective in the 5-year follow-up of patients with
nondysplastic metaplasia. For patients with low-
grade dysplasia it was proved effective in 81% of cas-
es [13] and in 90% for patients with high-grade dys-
plasia [16, 17]. The RFA method is almost as effective
as endoscopic mucosal resection but the percentage
of complications is lower [18]. The RFA-related com-
plications include nausea, chest pain, transient dyspha -
gia, esophageal wall injuries, stenosis, mediastinitis
and esophageal perforation [19-21]. The frequency of
RFA-related esophageal stenosis is estimated at 8%
and is much lower than 88% after endoscopic mucos-
al resection [21].
No significant RFA-related complications were ob -
served in our study group. This might be due to our
restrictive qualification criteria which deferred pa -
tients with erosive injuries of esophageal mucosa.
Performance of RFA in such patients might have led
to esophageal perforation and higher risk of local
stricture. It is equally important to avoid more than
one ablation therapy within the same area during
one procedure. Repeated ablation presents a similar
complication risk as procedure performed in patients
with mucosal injuries. Reliable information on the
safety of this method can be possible only after ana -
lysis of a larger group of patients during a longer
observation period. The reported case of a minor car-
cinoma focus in the gastro-esophageal junction locat-
ed under macroscopically normal mucosa proves the
need for regular and careful endoscopic surveillance
and follow-up of this group of patients. It is worth
noting that previous antireflux surgery and other sur-
gical procedures in the area of the esophagus and
mediastinum may impede RFA administration and in
some cases (surgical clips and stapler stitches) may
even inhibit this form of therapy. When planning to
combine these therapeutic methods it is therefore
mandatory to perform RFA as the first step and the
antireflux procedure as the subsequent one.
Conclusions
Based on our preliminary results we consider this
method to be promising, free of significant complica-
Videosurgery and Other Miniinvasive Techniques 2, June/2013
111
tions and well tolerated by patients. It was successful
for eradication of metaplastic epithelium in all of our
patients. Endoscopic imaging after therapy showed
no differences in physiological image. We cannot as
yet evaluate this method in terms of prophylaxis
against adenocarcinoma as this requires a long-term
evaluation of a larger group of patients. All patients
subjected to RFA procedures require further endo-
scopic surveillance and follow-up. The method can be
combined with antireflux surgery. However, due to
technical limitations the surgical procedures should
be performed after completion of HALO therapy.
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24.08.2012,
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8.09.2012,
aacccceepptteedd::
24.09.2012.
Radiofrequency ablation in the management of Barrett’s esophagus – preliminary own experience
... 3 Laparoscopic fundoplication is the standard treatment to restore the function of the lower oesophageal sphincter by wrapping the stomach around the oesophagus. 4 However, the approach of surgical treatment of large hernias can be challenging. The main technical concern is relocating the hernial contents into the abdominal cavity, repairing large diaphragmatic defects, dissection of adhesions with the abdomen and the mediastinum, and occasionally shortening of the oesophagus. ...
... Radiofrequency ablation thermally destroys the mucosa, but unlike in the case of mucosectomy, the mucosa cannot be sent for histological analysis. Nonetheless it is a very promising procedure which destroys Barrett's mucosa without leading to submucous scarring and esophageal functional impairment [10]. However, it is still a novel method and long-term results are not yet available [11]. ...
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Introduction Barrett's esophagus is the most significant precancer of the esophagus. Its malignization gives rise to most adenocarcinomas of the esophagus. Therefore selection of adequate therapy for this precancerous condition is of the utmost importance. Aim The authors of the work addressed the question of whether effective therapy of reflux disease alone may halt the process of malignization of Barrett's mucosa or even cause its regression. Material and methods The analyzed set comprised 50 patients with Barrett's esophagus, who in 48 cases underwent laparoscopic fundoplication and in two cases underwent an indirect antireflux procedure in the form of gastric resection with a Roux-en-Y gastrojejunal anastomosis. The effect of the procedure was evaluated by comparing preoperative and postoperative endoscopic examinations, as well as histological analysis by biopsy taken from Barrett's mucosa. Results In 19 patients (38%), Barrett's mucosa was not detected postoperatively. An improved finding in terms of disappearance of mucosal dysplasia was found in 8 (16%) patients. Findings remained unchanged in 18 (36%) patients. In 5 (10%) patients progression of the disease was discovered. Conclusions A surgical antireflux procedure, primarily in the form of laparoscopic fundoplication, is considered an effective method for treating Barrett's esophagus up to the stage of mild dysplasia. If this therapy is unsuccessful, the method of choice is local therapy, either an endoscopic mucosectomy or radiofrequency ablation.
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Introducción: el esófago de Barrett (EB) es el resultado de la injuria crónica del ácido sobre el epitelio esofágico por el RGE. Se define cuando el epitelio metaplásico columnar reemplaza al epitelio escamoso estratificado que normalmente recubre el esófago. El EB representa un factor de riesgo para el adenocarcinoma de esófago. El objetivo de la ablación por radiofrecuencia (RFA) es destruir el epitelio metaplásico con la corriente eléctrica de radiofrecuencia para estimular la reaparición del epitelio plano estratificado del esófago distal. Objetivo: evaluar la eficiencia y seguridad de la técnica de RFA, recientemente introducida en la ciudad de Medellín, Colombia, para el manejo del EB con displasia o carcinoma in situ. Materiales y métodos: diez pacientes fueron tratados con RFA. Pacientes con EB con displasia o carcinoma in situ como hallazgo histológico fueron elegidos para el tratamiento. La técnica de RFA se aplicó usando el equipo BARRX: el sistema circular HALO360 o el HALO90. Los efectos macro o microscópicos de la terapia con RFA, la tolerancia del paciente al tratamiento así como las complicaciones fueron evaluadas. Resultados: un grupo de 10 pacientes recibió la terapia con RFA, todos terminaron la terapia y el seguimiento. En siete pacientes había displasia de bajo grado, en dos de alto grado y un paciente con carcinoma in situ. Dos pacientes tenían resección endoscópica con bandas de nódulos de la mucosa previa a la terapia con RFA. Se realizaron un total de 13 procedimientos: 10 con HALO360, 2 HALO90 y un paciente tratado con argón plasma para un EB residual. En todos los pacientes se logró la erradicación del epitelio esofágico metaplásico y displásico como se confirmó en la evaluación endoscópica e histológica. No se encontraron complicaciones significativas relacionadas con la terapia de RFA, pero en dos pacientes se encontró estenosis del esófago y uno requirió dilataciones endoscópicas tres semanas después de la terapia. Conclusiones: con base en estos resultados preliminares consideramos que este es un método promisorio, sin mayores complicaciones y bien tolerado por el paciente. En la mayoría de pacientes se erradicó exitosamente el epitelio metaplásico y displásico del esófago distal.
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