Chronic Tonsillitis Clinical Trial
Official title:
Evaluation of Coblation Channeling Treatment for Chronic Tonsillitis.
To evaluate coblation channeling treatment for chronic tonsillitis. Does Tonsillar ablation can create changing in the tonsillar medium for recurrent tonsillar infections and stop the recurrent infections?
The palatine tonsil consists of an epithelial crypt (invaginated pocket) surrounded by dense
clusters of lymph nodules, each with a germinal center where lymphocytes proliferate. The
nodules are embedded in a mass of diffuse lymphoid tissue that consists of lymphocytes
migrating to and from the germinal centers.
Increasing the surface area of the crypts is one way to facilitate the contact of antigens
(bacteria) with the immune cells. The epithelium may specialize to form an openmeshwork of
cells which allows the infiltration of the epithelium by lymphocytes and macrophages.
Tonsillar lymphoid nodules consist mainly of B-lymphocytes. Other areas are occupied by
T-lymphocytes, activated B-lymphocytes and other cells of the immune system. Inside the
crypts, where cells of the immune system often invade the epithelium, it will be difficult
to find the specific boundary between epithelium and lymphoid tissue. The bacterial material
and biofilms1 sits in crypts and may start a new infection from time to time. The epithelium
lining the crypt corresponds with that on the adjacent surface - stratified squamous in the
tongue and palate or pseudo stratified columnar in the pharynx. In either case, the
epithelium may be heavily infiltrated with lymphocytes, and the crypt may be filled with
lymphocytes and other debris.
The tonsillar crypts have an important role in chronic tonsillitis. They are covered by
stratified epithelium and may be initiated via the epithelium to mount immune responses to
various presenting antigens. Go M. et al, investigated the expression and function of tight
junctions in the epithelium of human palatine tonsils from patients with tonsillar
hypertrophy or recurrent tonsillitis. These studies suggested unique expression of tight
junctions in human palatine tonsillar epithelium, and it was suggested that the crypt
epithelium may possess an epithelial barrier different from that of the surface epithelium2.
Bacteria within biofilms are resistant to host defenses and antibiotics. The presence of
bacterial biofilms within the tissue and crypts of inflamed tonsils may explain the chronic
and recurrent characteristics of some forms of tonsillitis. There is strong anatomical
evidence for the presence of bacterial biofilms in chronically diseased tonsils1. Using a
novel visualization approach in single sections of human mucosal tissue, the presence of
biofilms was demonstrated on tonsils in most (17/24 [70.8%]) patients with tonsillitis3.
One study investigated the difference in follicle size and numbers in tonsils for patients
with tonsillar hypertrophy and recurrent tonsillitis using an image analysis method. There
was no significant difference in the mean follicle numbers per counting field between
recurrent tonsillitis and tonsillar hypertrophy. However, they demonstrated that tonsillar
hypertrophy is characterized histologically by an enlargement of follicles compared with
recurrent tonsillitis, indicating a hyperplastic condition of lymphoid cells in the germinal
centers. It may also explain the difference in etiology and immune mechanism between
tonsillar hypertrophy and recurrent tonsillitis4.
Coblation is a non-heat driven process in which radiofrequency energy is applied to a
conductive medium (usually saline) causing a highly focused plasma field to form around the
electrodes. The plasma field is comprised of highly ionized particles. These ionized
particles have sufficient energy to break organic molecular bonds within tissue. Instead of
exploding tissue, coblation causes a low-temperature molecular disintegration, resulting in
minimal tissue damage to surrounding areas.
A novel treatment for chronic tonsillitis is now suggested by the inventors, this method
being based on treating the source of recurrent bacterial infections in the tonsillar
tissue, specifically the tonsillar crypts.
By treatment of the crypts and tonsillar tissue it may be possible to decrease the possible
antigen-immune system interaction and inflammation.
Without being bound to a specific theory, it is suggested that the combination of the radio
frequency energy and the fluid creates a "plasma" field containing highly ionized particles,
which have sufficient energy to break organic molecular bonds that can remove tissue
selectively without excessive heat production and damage the surrounding tissue.
Material and Methods
The study protocol was approved by the The Hillel Yaffe Medical Center's Ethics and Helsinki
Committee.
60 patients suffering from chronic tonsillitis will be treated by Coblation channeling to
the tonsils.
The treatment was conducted using an Arthrocare® Corporation (ArthroCare Corporation, 7500
Rialto Boulevard Austin, Texas 78735) COBLATION electrode ReFlex Ultra 55* for tonsillar
tissue ablation at low temperatures with only one treatment. All the patients underwent
tonsil channeling treatment with coblation, and 4-6 channels were done in each tonsil under
local anesthesia, in the operating room. The patients were observed overnight.
A control group included 60 patients with chronic tonsillitis with indication for
tonsillectomy will underwent tonsillectomy.
The patients selected are older than 18 years old, and were healthy, without any chronic
diseases other than chronic tonsillitis. Diagnosis of chronic tonsillitis was based on
history and medical examination. The criteria were: 1. At least 4 occasions of tonsillitis
in the last year that were treated (positive throat swab for Streptococci Group A will
contribute towards the diagnosis). 2. Recurrent or chronic throat pain. 3. Hypertrophic
tonsils of chronic tonsillitis. Patients that were not included: 1. Disease of the mouth or
pharyngeal mucosa-like ulcers. 2. Allergy to drugs. 3. Gastrointestinal reflux. 4. Any
contraindication for tonsillectomy. 5. Peritonsillar abscess in the past.
Final evaluations were by follow-up of the patients 1,2,4,6 and 12 months after the
beginning of treatment. At each visit, evaluation of the treatment was done by investigating
the degree of throat pain or tonsillitis after the treatment, number of tonsillitis per
year, examination of the tonsils, post treatment pain score by VISUAL-ANALOG-SCALE (VAS)
SCORES. The following parameters were recorded: the size of tonsils before and after
treatment, number of occurrences of tonsillitis after one year, and if there was any
post-treatment bleeding.
The results will be statistically evaluated .
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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