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?

Evaluation of Coblation Channeling Treatment for Chronic Tonsillitis.

Chronic Tonsillitis

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 .

Arthrocare® Corporation (ArthroCare Corporation, 7500 Rialto Boulevard Austin, Texas 78735) COBLATION electrode ReFlex Ultra 55*

tonsillectomy

the patient will be asked to report in specific time points in his/hers follow up: after
1 month, 2months, 4 months, 6 months and 12 months

Evaluation of Coblation Channeling Treatment for Chronic Tonsillitis.

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?