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Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules

H

hassan harby mohamed

Status and phase

Completed
Phase 1

Conditions

Thyroid Nodule

Treatments

Drug: ethanol injection

Study type

Interventional

Funder types

Other

Identifiers

NCT03257930
Ethanol Injection

Details and patient eligibility

About

Use of ethanol injection in treatment of cystic thyroid nodule

Full 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.

Enrollment

1 patient

Sex

All

Ages

15 to 60 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1 participants in 1 patient group

injection of ethanol
Experimental group
Description:
use of ethanol injection in the treatment of cystic thyroid nodule
Treatment:
Drug: ethanol injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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