Trial Information

Single Session Treatment of RFA Versus EA for Predominantly Cystic Thyroid Nodules: A Randomized Controlled Trial

Ablation Procedures Both RF ablation and EA will perform with each patient in the supine
position and with mild neck extension. Before the treatment, investigators will measure the
three orthogonal diameters of each nodule, i.e, the largest diameter and two other, mutually
perpendicular diameters, and the volume of each nodule was calculated using the equation V =
π abc/6, where V is the volume, a is the largest diameter, and b and c are the other two
diameters. Investigators will use 2% lidocaine at skin puncture site. The skin will be
punctured, and target nodules will be approached using the trans-isthmic approach method in
which the RF ablation electrode or EA needle is inserted into the short axis of the nodule
from the isthmus to the targeting nodule. This technical approach has several advantages. It
can prevent a change in the position of the needle or electrode when the patient is
swallowing or talking during the ablation and can also prevent fluid leakage, i.e. injected
ethanol or ablated, hot fluid of the cystic portion of thyroid nodules, to areas outside the
thyroid gland. This approach also allows clear, continuous US monitoring of the relationship
of the nodule, the needle or electrode tip, and the expected location of the recurrent
laryngeal nerve, thus minimizing the risks of injury to that nerve and/or the esophagus.

Radiofrequency Ablation All patients will be required to fast for at least six hours before
each procedure. Before starting the RF ablation, investigators will aspirate the internal
fluid as much as possible .

Moving shot technique for thyroid RF ablation has been proposed. In treatment of the liver,
the electrode is fixed during ablation. Because the thyroid is a relatively small organ
compared with the liver, prolonged fixation of the electrode is dangerous. Investigators
therefore divide thyroid nodules into multiple conceptual ablation units, and perform RF
ablation unit by unit by moving the electrode tip. These conceptual ablation units are
smaller in the periphery of the nodule and in the portion of the nodule adjacent to the
critical structures of the neck; however the units are larger in the central safe portion.
Initially, the electrode tip will be positioned in the deepest, most remote imaginary unit
of the nodule to enable easy monitoring of the electrode tip without the disturbance caused
by microbubbles. The electrode moves within the thyroid mass by tilting it upward or
downward. When ablation in the peripheral unit was finished, the electrode will be moved
backward and in the superficial direction. Ablation will begin with 40 W of RF power. If a
transient hyperechoic zone do not form at the electrode tip within 5-10 seconds, RF power
was increased in 10-W increments up to (100) W. If the patient do not tolerate pain during
the ablation, the RF power will be reduced or turned off. Ablation will be terminated when
all imaginary units had changed to transient hyperechoic zones.

Investigators will check for any possible complications both during and immediately after
the procedure in order to assess its safety. Procedure-related pain will be graded into four
categories, i.e. grade 0, RF power did not have to be turned off because a patient
experienced no pain; grade 1, RF power was turned off 1-2 times because the patient's pain;
grade 2, RF power was turned off more than three times because of the patient's pain; and
grade 3, RF procedure was incompletely terminated due to the patient's severe pain. After RF
ablation, each patient will be observed for 1-2 hours while still in the hospital.

Ethanol Ablation A 16- or 18-gauge needle will be inserted into the nodule through an
isthmus. After the needle tip is placed into the cystic portion, the internal fluid will be
aspirated to the maximal extent possible, followed by slow injection of 99% ethanol into the
cystic space. If the cyst contents are viscous, Investigators will aspirate viscous fluid
using a large-bore needle (16-gauge) attached to a 30-mL syringe, and followed by irrigation
with normal saline to remove viscous material attached to the cystic wall or solid
component, after which ethanol will be injected. The volume of ethanol injected usually
corresponded to 50% of the aspirated volume. After 2 minutes of ethanol retention with the
needle in place, the injected ethanol will be completely removed and the needle was
withdrawn. Investigators will not inject the ethanol to solid component. In order to assess
its safety, Investigators will check for any complications during and immediately after the
procedure. Procedure-related pain will be graded into four categories, i.e. grade 0, no pain
or mild pain similar to pain experienced during the lidocaine injection; grade 1, pain
greater than that of the lidocaine injection, but not requiring medication; grade 2, pain
requiring medication; and grade 3, the procedure was incompletely terminated due to severe
pain (1). Following the procedure, each patient was observed for 30 minutes while still in
the hospital.