Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules

Sponsor
hassan harby mohamed (Other)
Overall Status
Completed
CT.gov ID
NCT03257930
Collaborator
(none)
1
1
1
16.7
0.1

Study Details

Study Description

Brief Summary

Use of ethanol injection in treatment of cystic thyroid nodule

Condition or Disease Intervention/Treatment Phase
  • Drug: ethanol injection
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules
Actual Study Start Date :
Aug 11, 2017
Actual Primary Completion Date :
Jul 11, 2018
Actual Study Completion Date :
Jan 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: injection of ethanol

use of ethanol injection in the treatment of cystic thyroid nodule

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. symptomatic improvement [3 month]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 60 Years
Sexes Eligible for Study:
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:
  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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University Assiut Egypt 71511

Sponsors and Collaborators

  • hassan harby mohamed

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
hassan harby mohamed, general surgery, Assiut University
ClinicalTrials.gov Identifier:
NCT03257930
Other Study ID Numbers:
  • Ethanol Injection
First Posted:
Aug 22, 2017
Last Update Posted:
May 15, 2020
Last Verified:
May 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 15, 2020