Clinical trial NCT04580199: Surgical Versus Non Surgical Management of Thyroid Nodule
Official title: Surgical (Total or Hemithyroidectomy)Versus Non Surgical (Ethanol Ablation ,RF Ablation ,Laser Ablation) Management of Thyroid Nodule
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Nodule
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: age above 18 male or female manifested thyroid nodule
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* complicated thyroid nodule

Exclusion Criteria:

* less than 18 malignant thyroid nodule

Primary outcomes:
measure: shrinkage of the thyroid nodule
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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citation: 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.
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