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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
Mahmoud Fahd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Nodule

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 2, 2020
    Last Updated
    October 7, 2020
    Sponsor
    Mahmoud Fahd
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    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
    background
    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
    background
    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
    background
    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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