Surgical Versus Non Surgical Management of Thyroid Nodule
Primary Purpose
Thyroid Nodule
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
thyroidectomy
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Nodule
Eligibility Criteria
Inclusion Criteria:
- complicated thyroid nodule
Exclusion Criteria:
- less than 18 malignant thyroid nodule
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
total thyroidectomy
hemi thyroidectomy
ethanol ingection
monopolar radiofrequency
laser photocaugulation
Arm Description
excision of thyroid gland
excision half of thyroid gland
ingection of ethanol into thyroid nodule under guidance of ultrasound
using radiofrequency for ablation of thyroid nodule
using laser for ablation of thyroid nodule
Outcomes
Primary Outcome Measures
shrinkage of the thyroid nodule
decrease in the size of thyroid nodule
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04580199
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mahmoud Fahd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
age above 18 male or female manifested thyroid nodule
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
total thyroidectomy
Arm Type
Active Comparator
Arm Description
excision of thyroid gland
Arm Title
hemi thyroidectomy
Arm Type
Active Comparator
Arm Description
excision half of thyroid gland
Arm Title
ethanol ingection
Arm Type
Active Comparator
Arm Description
ingection of ethanol into thyroid nodule under guidance of ultrasound
Arm Title
monopolar radiofrequency
Arm Type
Active Comparator
Arm Description
using radiofrequency for ablation of thyroid nodule
Arm Title
laser photocaugulation
Arm Type
Active Comparator
Arm Description
using laser for ablation of thyroid nodule
Intervention Type
Procedure
Intervention Name(s)
thyroidectomy
Other Intervention Name(s)
ethanol ablation RF ablation laser photocaugulation
Intervention Description
to excise the thyroid gland
Primary Outcome Measure Information:
Title
shrinkage of the thyroid nodule
Description
decrease in the size of thyroid nodule
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
complicated thyroid nodule
Exclusion Criteria:
less than 18 malignant thyroid nodule
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31040749
Citation
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.
Results Reference
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PubMed Identifier
30440161
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.
Results Reference
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PubMed Identifier
30887743
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.
Results Reference
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PubMed Identifier
29490593
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.
Results Reference
background
PubMed Identifier
30517361
Citation
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.
Results Reference
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Surgical Versus Non Surgical Management of Thyroid Nodule
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