Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules

Thyroid Nodule Clinical Trial

Official title:

Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03257930
• Other study ID #: Ethanol Injection
• Status: Completed
• Phase: Phase 1
• Start date: August 11, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: May 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Use of ethanol injection in treatment of cystic thyroid nodule

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: January 1, 2019
• Est. primary completion date: July 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Adult male or female patient with cystic thyroid nodule

2. Presence of pressure symptoms or cosmetic problems

3. Benign lesions confirmed by histopathological examination by FNAC.

4. Serum levels of thyroid hormone thyrotropin, within normal limits.

Exclusion Criteria:

1. Nodules showing malignant features(ie, speculated margin, markedly hypo echoic, micro- or macro calcifications) at US

2. solid thyroid nodule

3. mixed thyroid nodule(cystic with solid component)

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule

Intervention

Drug:
• ethanol injection
inject ethanol in cystic thyroid nodule and follow up until complete recovery

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
hassan harby mohamed

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Monzani F, Lippi F, Goletti O, Del Guerra P, Caraccio N, Lippolis PV, Baschieri L, Pinchera A. Percutaneous aspiration and ethanol sclerotherapy for thyroid cysts. J Clin Endocrinol Metab. 1994 Mar;78(3):800-2. — View Citation

Vogel D, Durham AC, de Marcillac GD. Metastable aggregates in the polymerisation of tobacco-mosaic-virus protein. Eur J Biochem. 1977 Sep 15;79(1):161-71. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	symptomatic improvement	cosmetic improvement of the ugly appearance of the cyst from the neck	3 month