Surgical Versus Non Surgical Management of Thyroid Nodule

NCT ID: NCT04580199

Last Updated: 2020-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-12-01

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

Conditions

Thyroid Nodule

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

total thyroidectomy

excision of thyroid gland

Group Type: ACTIVE_COMPARATOR

thyroidectomy

Intervention Type: PROCEDURE

to excise the thyroid gland

hemi thyroidectomy

excision half of thyroid gland

Group Type: ACTIVE_COMPARATOR

thyroidectomy

Intervention Type: PROCEDURE

to excise the thyroid gland

ethanol ingection

ingection of ethanol into thyroid nodule under guidance of ultrasound

Group Type: ACTIVE_COMPARATOR

thyroidectomy

Intervention Type: PROCEDURE

to excise the thyroid gland

monopolar radiofrequency

using radiofrequency for ablation of thyroid nodule

Group Type: ACTIVE_COMPARATOR

thyroidectomy

Intervention Type: PROCEDURE

to excise the thyroid gland

laser photocaugulation

using laser for ablation of thyroid nodule

Group Type: ACTIVE_COMPARATOR

thyroidectomy

Intervention Type: PROCEDURE

to excise the thyroid gland

Interventions

thyroidectomy

to excise the thyroid gland

Intervention Type: PROCEDURE

Other Intervention Names

ethanol ablation RF ablation laser photocaugulation

Eligibility Criteria

Inclusion Criteria

• complicated thyroid nodule

Exclusion Criteria

• less than 18 malignant thyroid nodule

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahmoud Fahd

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Fahd

principle investigator Mahmoud fahd

Responsibility Role: SPONSOR_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 31040749 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30440161 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30887743 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29490593 (View on PubMed)

Rahal Junior A, Falsarella PM, Mendes GF, Hidal JT, Andreoni DM, Lucio 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.

Reference Type: BACKGROUND

PMID: 30517361 (View on PubMed)

Other Identifiers

thyroid nodule

Identifier Type: -

Identifier Source: org_study_id