Surgical Versus Non Surgical Management of Thyroid Nodule

Mahmoud Fahd

Status: Unknown

Conditions: Thyroid Nodule

Treatments: Procedure: thyroidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04580199

thyroid nodule

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• complicated thyroid nodule

Exclusion criteria

• less than 18 malignant thyroid nodule

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 5 patient groups

total thyroidectomy

Active Comparator group

Description:

excision of thyroid gland

Treatment:

Procedure: thyroidectomy

hemi thyroidectomy

Active Comparator group

Description:

excision half of thyroid gland

Treatment:

Procedure: thyroidectomy

ethanol ingection

Active Comparator group

Description:

ingection of ethanol into thyroid nodule under guidance of ultrasound

Treatment:

Procedure: thyroidectomy

monopolar radiofrequency

Active Comparator group

Description:

using radiofrequency for ablation of thyroid nodule

Treatment:

Procedure: thyroidectomy

laser photocaugulation

Active Comparator group

Description:

using laser for ablation of thyroid nodule

Treatment:

Procedure: thyroidectomy