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CompletedNCT03257930Updated May 15, 2020

Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules

A Phase 1 interventional study of ethanol injection in Thyroid Nodule, sponsored by hassan harby mohamed. Completed at 1 site in Egypt. Open to participants aged 15 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-15.

Sponsored by hassan harby mohamed · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
15 Years to 60 Years
Sex
All
01

Study summary

Use of ethanol injection in treatment of cystic thyroid nodule

Read the 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.

02

Conditions studied

  • Thyroid Nodule
03

Who can participate

Ages eligible
15 Years to 60 Years
Sexes eligible
All
Accepts 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

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)
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    injection of ethanol

    use of ethanol injection in the treatment of cystic thyroid nodule

    Drug: ethanol injection

Interventions

  • Drugethanol injection

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

05

What researchers measure

Primary outcomes

  1. Reduction of volume of the cyst about 96.9%

    Reduction of volume of the cyst about 96.9%

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

Secondary outcomes

  1. symptomatic improvement

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

    Time frame: 3 month

06

Study locations

1 site
  • Assiut University
    Assiut, 71511, Egypt
07

References and documents

Publications

  • 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. doi: 10.1111/j.1432-1033.1977.tb11794.x. No abstract available. PubMed 21087 ↗
  • 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. doi: 10.1210/jcem.78.3.8126160. PubMed 8126160 ↗
08

Registry details

Key details

Study ID
NCT03257930
Lead sponsor
hassan harby mohamed
Responsible party
hassan harby mohamed (general surgery, Assiut University) — Sponsor-investigator
First posted
Aug 22, 2017
Start date
Aug 11, 2017
Primary completion
Jul 11, 2018
Completion
Jan 1, 2019
Last update
May 15, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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