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

Role of Selective Embolization of Thyroid Arteries (SETA) as an Adjunctive or Definitive 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

Study Overview

• Status: Not yet recruiting
• Conditions: Graves Disease; Goiter, Nodular; Goiter Malignant; Goiter Diffuse
• Intervention / Treatment: Procedure: selective embolization of thyroid arteries (SETA)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: graves disease patients	Procedure: selective embolization of thyroid arteries (SETA); selective embolization of thyroid arteries
Active Comparator: multinodular goiter	Procedure: selective embolization of thyroid arteries (SETA); selective embolization of thyroid arteries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To investigate the safety of selective embolization of thyroid arteries (SETA) as adjunctive or definitive treatment in different thyroid disorders	Safety measured according to incidence of major and minor complications compared to thyroidectomy.	Up to 12 months follow up after embolization
To investigate the efficacy of selective embolization of thyroid arteries (SETA) as adjunctive or definitive treatment in different thyroid disorders	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	Up to 12 months follow up after embolization

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): August 10, 2024
• Primary Completion (Estimated): July 9, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Estimated): August 5, 2024

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Embolization of thyroid arteries
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Eye Diseases; Endocrine System Diseases; Exophthalmos; Orbital Diseases; Hyperthyroidism; Thyroid Diseases; Goiter; Goiter, Nodular; Graves Disease
• Other Study ID Numbers: 3ekremaH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No