Percutaneous Ethanol Injection for Benign Cystic Thyroid... | NCT03257930

Studies
Percutaneous Ethanol Injection for Benign Cystic Thyroid Nodules

NCT03257930

Sponsor

hassan harby mohamed

Status

Completed

Last Update Posted

May 15, 2020Actual

Enrollment

1Actual

Phase

Phase 1

Conditions

Thyroid Nodule

Interventions

ethanol injection

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 11, 2017Actual

Primary Completion Date

Jul 11, 2018Actual

Completion Date

Jan 1, 2019Actual

First Submitted Date

Aug 17, 2017

First Submission Date that Met QC Criteria

Aug 21, 2017

First Posted Date

Aug 22, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2020

Last Update Posted Date

May 15, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

hassan harby mohamed, general surgery, Assiut UniversitySponsor-Investigator

Lead Sponsor

hassan harby mohamedOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
injection of ethanol	Experimental	use of ethanol injection in the treatment of cystic thyroid nodule	Drug: ethanol injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ethanol injection	Drug	inject ethanol in cystic thyroid nodule and follow up until complete recovery	injection of ethanol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of volume of the cyst about 96.9%	Reduction of volume of the cyst about 96.9%	Reduction of volume of the cyst about 96.9% within 6 month

Secondary Outcomes

Measure	Description	Time Frame
symptomatic improvement	cosmetic improvement of the ugly appearance of the cyst from the neck	3 month

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut University		Asyut		71511	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21087	Background	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.
8126160	Background	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.

ID	Term
D013964	Thyroid Neoplasms
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D000438	Alcohols
D009930	Organic Chemicals