Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules

Phase 1

Completed

• Conditions: Thyroid Nodule
• Interventions: Drug: ethanol injection

• Registration Number: NCT03257930
• Lead Sponsor: hassan harby mohamed

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.

Study Timeline

• Study Start: 2017-08-11
• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-08-21
• Study First Posted: 2017-08-22
• Primary Completion: 2018-07-11
• Study Completion: 2019-01-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-13
• Last Update Posted: 2020-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
injection of ethanol	ethanol injection	use of ethanol injection in the treatment of cystic thyroid nodule

Primary Outcome Measures

Name	Time	Method
Reduction of volume of the cyst about 96.9%	Reduction of volume of the cyst about 96.9% within 6 month	Reduction of volume of the cyst about 96.9%

Secondary Outcome Measures

Name	Time	Method
symptomatic improvement	3 month	cosmetic improvement of the ugly appearance of the cyst from the neck

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt