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

NCT ID: NCT06537141

Last Updated: 2024-08-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-10
• Study Completion Date: 2026-07-30

Brief Summary

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

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

Conditions

Graves Disease; Goiter, Nodular; Goiter Malignant; Goiter Diffuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

graves disease patients

Group Type: ACTIVE_COMPARATOR

selective embolization of thyroid arteries (SETA)

Intervention Type: PROCEDURE

selective embolization of thyroid arteries

multinodular goiter

Group Type: ACTIVE_COMPARATOR

selective embolization of thyroid arteries (SETA)

Intervention Type: PROCEDURE

selective embolization of thyroid arteries

Interventions

selective embolization of thyroid arteries (SETA)

selective embolization of thyroid arteries

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

abdelRahman Ahmad abdAllah

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

3ekremaH

Identifier Type: -

Identifier Source: org_study_id