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OpenTrials
Completed

NCT Number: NCT03257930

Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules

Use of ethanol injection in treatment of cystic thyroid nodule

Completed

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Key information

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Assiut University

Asyut, 71511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ethanol Injection

Drug

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

Primary outcomes

  1. Reduction of volume of the cyst about 96.9%

    Time frame: Reduction of volume of the cyst about 96.9% within 6 month

    Reduction of volume of the cyst about 96.9%

Secondary outcomes

  1. symptomatic improvement

    Time frame: 3 month

    cosmetic improvement of the ugly appearance of the cyst from the neck

Sponsors and collaborators

Lead sponsor

hassan harby mohamed

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 22, 2017
Registry last updated
May 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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