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Clinical Trials/NCT04580199
NCT04580199UnknownNot Applicable

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

Mahmoud Fahd0 sites100 target enrollmentStarted: December 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
100
Primary Endpoint
shrinkage of the thyroid nodule

Study Overview

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

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • complicated thyroid nodule

Exclusion Criteria

  • less than 18 malignant thyroid nodule

Arms & Interventions

total thyroidectomy

Active Comparator

excision of thyroid gland

Intervention: thyroidectomy (Procedure)

hemi thyroidectomy

Active Comparator

excision half of thyroid gland

Intervention: thyroidectomy (Procedure)

ethanol ingection

Active Comparator

ingection of ethanol into thyroid nodule under guidance of ultrasound

Intervention: thyroidectomy (Procedure)

monopolar radiofrequency

Active Comparator

using radiofrequency for ablation of thyroid nodule

Intervention: thyroidectomy (Procedure)

laser photocaugulation

Active Comparator

using laser for ablation of thyroid nodule

Intervention: thyroidectomy (Procedure)

Outcomes

Primary Outcomes

shrinkage of the thyroid nodule

Time Frame: 2 years

decrease in the size of thyroid nodule

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Mahmoud Fahd
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Mahmoud Fahd

principle investigator Mahmoud fahd

Assiut University

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