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NCT Number: NCT06537141

Role of Embolization of Thyroid Arteries as a Treatment for Different Thyroid Disorders

To investigate the safety and efficacy of selective embolization of thyroid arteries (SETA) as adjunctive or definitive treatment in different thyroid disorders

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Key information

About this study

In graves disease Traditional forms of treatment of the thyroid diseases: pharmacotherapy, radioiodine therapy and surgery can not always be applied. Intolerance, side effects of antithyroid drugs, low iodine uptake, high risk of surgery or disagreement with the proposed treatment was the reason for seeking alternative treatment methods.

Also in cases of large sized thyroid nodule and retrosternal extension, surgery may carries out a lot of comorbidities .

With the development of interventional radiology, and gained experience in the use of arterial embolization, this method has become possible to use in treatment of thyroid diseases. The essence of this treatment is to shut down blood flow in major arteries of the thyroid by direct injection of embolizing materials (PVA) into the vessel's.

. The consequence of acute ischemia is necrosis of the glandular tissue in a field being supplied by this artery. Further repair processes and fibrosis lead to a reduction of active thyroid hormone synthesis and restriction of thyroid gland. Effects of embolization on angiogenesis, apoptosis and autoimmune reactions contribute to compensation thyroid function and significant reduction a goiter volume in course of Graves' disease. Preoperative selective embolization of a huge goiter or thyroid cancer improves surgery outcomes, reduces the risk of hemorrhage and damage to surrounding tissue. Palliative use of embolization in advanced stages of thyroid cancer reduces symptoms and improves quality of life. Little invasive nature of this procedure, the lack of serious undesirable coincidence makes embolization of thyroid arteries an attractive form of a therapy, which may become a therapeutic option in many difficult clinical situations and improve the clinical effectiveness of treatment of thyroid disease

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

A- diffuse and Nodular goiter:

B-Toxic goiter:

C-Thyroid cancer:

Exclusion criteria

A. Significant bleeding diathesis. B. Contraindication for contrast media (renal impairment or allergy). C. Severe atherosclerotic disease prevent arterial catheterization. D. Refusal of signing a consent

Treatment and study plan

selective embolization of thyroid arteries (SETA)

Procedure

selective embolization of thyroid arteries

Primary outcomes

  1. To investigate the safety of selective embolization of thyroid arteries (SETA) as adjunctive or definitive treatment in different thyroid disorders

    Time frame: Up to 12 months follow up after embolization

    Safety measured according to incidence of major and minor complications compared to thyroidectomy.

  2. To investigate the efficacy of selective embolization of thyroid arteries (SETA) as adjunctive or definitive treatment in different thyroid disorders

    Time frame: Up to 12 months follow up after embolization

    in hyperfunctiong (toxic) disorders Efficacy measured according to thyroid profile levels in certain time interval post procedure, every 3 months time interval and rate of hyper functioning recurrence in comparison to thyroidectomy.

    In diffuse or nodular goiter we measure efficacy by percentage of size reduction post procedure in comparison to primary size just before procedure

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Role of Selective Embolization of Thyroid Arteries (SETA) as an Adjunctive or Definitive Treatment for Different Thyroid Disorders

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2024
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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