Surgical Versus Non Surgical Management of Thyroid Nodule

Thyroid Nodule Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04580199
• Other study ID #: thyroid nodule
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: October 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• complicated thyroid nodule

Exclusion Criteria:

• less than 18 malignant thyroid nodule

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule

Intervention

Procedure:
• thyroidectomy
to excise the thyroid gland

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahmoud Fahd

References & 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. — View Citation

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. — View Citation

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. Review. — View 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. — View Citation

Rahal Junior A, Falsarella PM, Mendes GF, Hidal JT, Andreoni DM, Lúcio 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. English, Portuguese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	shrinkage of the thyroid nodule	decrease in the size of thyroid nodule	2 years