NCT04580199

Brief Summary

To compare between surgical (hemi thyroidectomy and total thyroidectomy) and non-surgical (medical, ethanol injection,thermal ablation and laser photo coagulation) management of simple thyroid nodule regarding:

  • Outcome of every type of management
  • Feasibility of minimally invasive technique in management of simple thyroid nodule in Asyut university
  • Complication of every type of management

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

October 9, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

October 2, 2020

Last Update Submit

October 7, 2020

Conditions

Thyroid Nodule

Outcome Measures

Primary Outcomes (1)

  • shrinkage of the thyroid nodule

    decrease in the size of thyroid nodule

    2 years

Study Arms (5)

total thyroidectomy

ACTIVE COMPARATOR

excision of thyroid gland

Procedure: thyroidectomy

hemi thyroidectomy

ACTIVE COMPARATOR

excision half of thyroid gland

Procedure: thyroidectomy

ethanol ingection

ACTIVE COMPARATOR

ingection of ethanol into thyroid nodule under guidance of ultrasound

Procedure: thyroidectomy

monopolar radiofrequency

ACTIVE COMPARATOR

using radiofrequency for ablation of thyroid nodule

Procedure: thyroidectomy

laser photocaugulation

ACTIVE COMPARATOR

using laser for ablation of thyroid nodule

Procedure: thyroidectomy

Interventions

thyroidectomyPROCEDURE

to excise the thyroid gland

Also known as: ethanol ablation RF ablation laser photocaugulation
ethanol ingectionhemi thyroidectomylaser photocaugulationmonopolar radiofrequencytotal thyroidectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • complicated thyroid nodule

You may not qualify if:

  • less than 18 malignant thyroid nodule

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Benjamin J, Hephzibah J, Cherian AJ, Mathew D, Shanthly N, Oommen R. Is hemi-thyroidectomy adequate in low risk differentiated thyroid cancer? World J Nucl Med. 2019 Apr-Jun;18(2):171-175. doi: 10.4103/wjnm.WJNM_70_18.

    PMID: 31040749BACKGROUND

  • Mauri G, Nicosia L, Della Vigna P, Varano GM, Maiettini D, Bonomo G, Giuliano G, Orsi F, Solbiati L, De Fiori E, Papini E, Pacella CM, Sconfienza LM. Percutaneous laser ablation for benign and malignant thyroid diseases. Ultrasonography. 2019 Jan;38(1):25-36. doi: 10.14366/usg.18034. Epub 2018 Sep 17.

    PMID: 30440161BACKGROUND

  • Hahn SY, Shin JH, Na DG, Ha EJ, Ahn HS, Lim HK, Lee JH, Park JS, Kim JH, Sung JY, Lee JH, Baek JH, Yoon JH, Sim JS, Lee KH, Baek SM, Jung SL, Kim YK, Choi YJ; Korean Society of Thyroid Radiology (KSThR); Korean Society of Radiology. Ethanol Ablation of the Thyroid Nodules: 2018 Consensus Statement by the Korean Society of Thyroid Radiology. Korean J Radiol. 2019 Apr;20(4):609-620. doi: 10.3348/kjr.2018.0696.

    PMID: 30887743BACKGROUND

  • Dobnig H, Amrein K. Monopolar Radiofrequency Ablation of Thyroid Nodules: A Prospective Austrian Single-Center Study. Thyroid. 2018 Apr;28(4):472-480. doi: 10.1089/thy.2017.0547. Epub 2018 Mar 20.

    PMID: 29490593BACKGROUND

  • Rahal Junior A, Falsarella PM, Mendes GF, Hidal JT, Andreoni DM, Lucio JFF, Queiroz MRG, Garcia RG. Percutaneous laser ablation of benign thyroid nodules: a one year follow-up study. Einstein (Sao Paulo). 2018 Nov 29;16(4):eAO4279. doi: 10.31744/einstein_journal/2018AO4279.

    PMID: 30517361BACKGROUND

MeSH Terms

Conditions

Thyroid Nodule

Interventions

Thyroidectomy

Condition Hierarchy (Ancestors)

Thyroid NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: age above 18 male or female manifested thyroid nodule
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principle investigator Mahmoud fahd

Study Record Dates

First Submitted

October 2, 2020

First Posted

October 8, 2020

Study Start

December 1, 2020

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

October 9, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share