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Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules

Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03257930
Enrollment
1
Registered
2017-08-22
Start date
2017-08-11
Completion date
2019-01-01
Last updated
2020-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroid Nodule

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.

Interventions

inject ethanol in cystic thyroid nodule and follow up until complete recovery

Sponsors

hassan harby mohamed
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Reduction of volume of the cyst about 96.9%Reduction of volume of the cyst about 96.9% within 6 monthReduction of volume of the cyst about 96.9%

Secondary

MeasureTime frameDescription
symptomatic improvement3 monthcosmetic improvement of the ugly appearance of the cyst from the neck

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026