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Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules

Primary Purpose

Thyroid Nodule

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
ethanol injection
Sponsored by
hassan harby mohamed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Nodule

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesAccepts 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)

Sites / Locations

  • Assiut University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

injection of ethanol

Arm Description

use of ethanol injection in the treatment of cystic thyroid nodule

Outcomes

Primary Outcome Measures

Reduction of volume of the cyst about 96.9%
Reduction of volume of the cyst about 96.9%

Secondary Outcome Measures

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

Full Information

First Posted
August 17, 2017
Last Updated
May 13, 2020
Sponsor
hassan harby mohamed
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1. Study Identification

Unique Protocol Identification Number
NCT03257930
Brief Title
Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules
Official Title
Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
August 11, 2017 (Actual)
Primary Completion Date
July 11, 2018 (Actual)
Study Completion Date
January 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
hassan harby mohamed

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
injection of ethanol
Arm Type
Experimental
Arm Description
use of ethanol injection in the treatment of cystic thyroid nodule
Intervention Type
Drug
Intervention Name(s)
ethanol injection
Intervention Description
inject ethanol in cystic thyroid nodule and follow up until complete recovery
Primary Outcome Measure Information:
Title
Reduction of volume of the cyst about 96.9%
Description
Reduction of volume of the cyst about 96.9%
Time Frame
Reduction of volume of the cyst about 96.9% within 6 month
Secondary Outcome Measure Information:
Title
symptomatic improvement
Description
cosmetic improvement of the ugly appearance of the cyst from the neck
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71511
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
21087
Citation
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.
Results Reference
background
PubMed Identifier
8126160
Citation
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.
Results Reference
background

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Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules

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