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Surgical Versus Non Surgical Management of Thyroid Nodule

Sponsor
Mahmoud Fahd (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04580199
Collaborator
(none)
100
Enrollment
5
Arms
24
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: thyroidectomy
 N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
age above 18 male or female manifested thyroid noduleage above 18 male or female manifested thyroid nodule
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Surgical (Total or Hemithyroidectomy)Versus Non Surgical (Ethanol Ablation ,RF Ablation ,Laser Ablation) Management of Thyroid Nodule
Anticipated Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: total thyroidectomy

excision of thyroid gland

Procedure: thyroidectomy
to excise the thyroid gland
Other Names:
  • ethanol ablation RF ablation laser photocaugulation

    		•
    Active Comparator: hemi thyroidectomy

    excision half of thyroid gland

    Procedure: thyroidectomy
    to excise the thyroid gland
    Other Names:
  • ethanol ablation RF ablation laser photocaugulation

    		•
    Active Comparator: ethanol ingection

    ingection of ethanol into thyroid nodule under guidance of ultrasound

    Procedure: thyroidectomy
    to excise the thyroid gland
    Other Names:
  • ethanol ablation RF ablation laser photocaugulation

    		•
    Active Comparator: monopolar radiofrequency

    using radiofrequency for ablation of thyroid nodule

    Procedure: thyroidectomy
    to excise the thyroid gland
    Other Names:
  • ethanol ablation RF ablation laser photocaugulation

    		•
    Active Comparator: laser photocaugulation

    using laser for ablation of thyroid nodule

    Procedure: thyroidectomy
    to excise the thyroid gland
    Other Names:
  • ethanol ablation RF ablation laser photocaugulation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. shrinkage of the thyroid nodule [2 years]

      decrease in the size of thyroid nodule

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • complicated thyroid nodule
    Exclusion Criteria:
    • less than 18 malignant thyroid nodule

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mahmoud Fahd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mahmoud Fahd, principle investigator Mahmoud fahd, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04580199
    Other Study ID Numbers:
    • thyroid nodule
    First Posted:
    Oct 8, 2020
    Last Update Posted:
    Oct 9, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Thyroid Nodule
    Thyroid Diseases
    Ethanol

    Study Results

    No Results Posted as of Oct 9, 2020