Surgical Versus Non Surgical Management of Thyroid Nodule

October 7, 2020 updated by: Mahmoud Fahd

Surgical (Total or Hemithyroidectomy)Versus Non Surgical (Ethanol Ablation ,RF Ablation ,Laser Ablation) Management of Thyroid Nodule

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Thyroid nodules are very common in clinical practice; they are discovered by palpation in 3-7% and by ultrasound (US) in about 50% of the general population. The majority of thyroid nodules are benign and asymptomatic. The main management of benign thyroid nodules is observation and follow-up; however, a minority of them (10-15%) increase in size over time and may induce symptoms or cosmetic issues. Surgical excision has been established as a treatment for symptomatic benign thyroid nodules. thyroidectomy for benign thyroid disease continues to remain controversial, as there are many conflicting data published in the literature regarding the risk of hypothyroidism and recurrent laryngeal nerve injury stratified to indications for surgery, extent of thyroid resection and surgical volume .It carries a 2-10% risk of complications and neck scarring .Thyroid surgery is also costly and may not be appropriate for patients who have a high risk of surgical morbidity.Therefore, image-guided nonsurgical procedures such as ethanol ablation (EA) and thermal ablation have been proposed as alternative and less invasive approaches for the management of benign symptomatic thyroid nodules .These so-called thermoablative methods induce local thermodestruction, leading to nodule shrinkage and improvement of local symptoms. Monopolar radiofrequency ablation (RFA) and EA is widely used as a nonsurgical treatment usually for cystic (i.e., pure cyst) or predominantly cystic benign thyroid nodules (i.e., cystic portion > 50%). There is another method called US-guided percutaneous laser ablation (PLA) is a safe and effective therapeutic option as an alternative to surgery for benign symptomatic nodules

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • complicated thyroid nodule

Exclusion Criteria:

  • less than 18 malignant thyroid nodule

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: total thyroidectomy
excision of thyroid gland
Procedure: thyroidectomy
to excise the thyroid gland
Other Names:
  • ethanol ablation RF ablation laser photocaugulation
Active Comparator: hemi thyroidectomy
excision half of thyroid gland
Procedure: thyroidectomy
to excise the thyroid gland
Other Names:
  • ethanol ablation RF ablation laser photocaugulation
Active Comparator: ethanol ingection
ingection of ethanol into thyroid nodule under guidance of ultrasound
Procedure: thyroidectomy
to excise the thyroid gland
Other Names:
  • ethanol ablation RF ablation laser photocaugulation
Active Comparator: monopolar radiofrequency
using radiofrequency for ablation of thyroid nodule
Procedure: thyroidectomy
to excise the thyroid gland
Other Names:
  • ethanol ablation RF ablation laser photocaugulation
Active Comparator: laser photocaugulation
using laser for ablation of thyroid nodule
Procedure: thyroidectomy
to excise the thyroid gland
Other Names:
  • ethanol ablation RF ablation laser photocaugulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
shrinkage of the thyroid nodule
Time Frame: 2 years
decrease in the size of thyroid nodule
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahmoud Fahd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2020

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 2, 2020

First Submitted That Met QC Criteria

October 2, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

October 9, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • thyroid nodule

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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