Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules

Study Overview
=================
Brief Summary
-----------------
Use of ethanol injection in treatment of cystic thyroid nodule

Detailed Description
-----------------
Thyroid nodules are common discreet lesions in the parenchyma of thyroid gland which can either be palpated or made out during imaging like ultrasonography (USG).Clinically palpable thyroid nodules have a prevalence of 4-7% in the general population . However, the prevalence increases to 20-76% when USG is used for detection. Goiter and the associated thyroid nodules result in anxiety, cosmetic disfigurement, and rarely compressive symptoms necessitating surgical removal, a procedure inherently associated with risks and complications Percutaneous sclerotherapy has been suggested to be an effective alternative, especially in patients with cystic nodules. Simple cystic (purely cystic) constitutes 6-28% of all thyroid nodules, are usually benign, filled with cellular debris or blood, and are a result of degeneration or hemorrhage into a hyperplastic nodule. Among the various compounds (sodium tetradocyl sulfate, hydroxypolyethoxydodecan, tetracycline, and ethanol) tried for sclerosis of cystic thyroid nodules, outcomes are best and most studied with ethanol. However, data on outcomes of percutaneous aspiration and ethanol injection (PEI) in resolution of thyroid nodules is highly variable in different studies (success rate: 38-85%), which may be due to different populations studied and the heterogeneous nature of thyroid nodules evaluated.

Official Title
-----------------
Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules

Conditions
-----------------
Thyroid Nodule

Intervention / Treatment
-----------------
* Drug: ethanol injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male or female patient with cystic thyroid nodule Presence of pressure symptoms or cosmetic problems Benign lesions confirmed by histopathological examination by FNAC. Serum levels of thyroid hormone thyrotropin, within normal limits. Exclusion Criteria: Nodules showing malignant features(ie, speculated margin, markedly hypo echoic, micro- or macro calcifications) at US solid thyroid nodule mixed thyroid nodule(cystic with solid component)

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: injection of ethanol<br>use of ethanol injection in the treatment of cystic thyroid nodule | Drug: ethanol injection<br>* inject ethanol in cystic thyroid nodule and follow up until complete recovery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of volume of the cyst about 96.9% | Reduction of volume of the cyst about 96.9% | Reduction of volume of the cyst about 96.9% within 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptomatic improvement | cosmetic improvement of the ugly appearance of the cyst from the neck | 3 month |