Role of Uterine Artery Embolization in Adenomyosis

NCT ID: NCT05597644

Last Updated: 2022-10-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-12-31

Brief Summary

Management of symptomatizing women diagnosed with uterine adenomyosis, by uterine artery angioembolization as a minimally invasive replacement for hysterectomy. This is followed by assessment of the symptoms and MRI of the pelvis after 3 months.

Detailed Description

Adenomyosis is defined by the abnormal location of endometrial tissue within the myometrium associated with hypertrophy or hyperplasia of the myometrial stroma. Although pathogenesis and etiology of adenomyosis remain unknown, two main theories have been proposed: invagination of the endometrial basal layer and metaplasia of embryonic stem cells. Despite the absence of specific (pathognomonic) diagnostic features for uterine adenomyosis, typical symptoms include menorrhagia, chronic pelvic pain, and dysmenorrhea.

For more than a century, diagnosis was dependent on histopathologic examination of post-hysterectomy specimens till the introduction of noninvasive ultrasound and MR techniques. Since then, several studies have illustrated high sensitivities and specificities for both two-dimensional transvaginal sonography (TVS) and magnetic resonance imaging (MRI). Current treatment options for symptomatic adenomyosis include hysterectomy, medication, conservative surgery, or minimally invasive techniques including uterine artery embolization. To date, hysterectomy remains the definitive treatment. This is mainly due to difficult diagnosis, the diffuse nature of the disease, and little evidence-based literature needed to standardize treatments. This consequently results in a management dilemma, particularly in symptomatic patients who wish to preserve their uterus.

Uterine artery embolization is the use of transarterial catheters aiming to induce more than 34% necrosis within adenomyotic tissues. Vascular access is gained through a femoral or radial artery puncture using 4-6-French (F) arterial sheath for femoral and 4-F sheath for radial access. Under fluoroscopic guidance, aortography is followed by selective and super selective arteriography using 4-5-F catheters for the internal iliac and 2-3-F microcatheters for the uterine artery and its branches respectively. Embolization is usually performed using variable-sized permanent particulate agents.

Conditions

Adenomyosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

females with adenomyosis

Group Type: EXPERIMENTAL

Trans-arterial uterine artery embolization

Intervention Type: PROCEDURE

transarterial angioembolization of uterine artery

Interventions

Trans-arterial uterine artery embolization

transarterial angioembolization of uterine artery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Symptomatizing women (pelvic pain and/or bleeding) between ages 30-50 who are not keen on hysterectomy.

Exclusion Criteria

• Women who desire further child bearing (not completed their family yet).
• Impaired coagulation profile.
• Hypersensitivity to intravenous contrast media.
• Decompensated congestive heart failure.
• Hypertensive crisis.
• Stroke or CVA.
• Renal failure.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Moustafa Tarek Khalaf Al-Hussaini

Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ehab Mansour, Assistant Professor

Role: STUDY_DIRECTOR

Assiut University

Abd ElKareem Hasan, Professor

Role: STUDY_CHAIR

Assiut University

Central Contacts

Moustafa Al-Hussaini, Specialist

Role: CONTACT

moustafa71989@gmail.com

01023646463

Mahmoud Refaat, Lecturer

Role: CONTACT

mahmoud.abdelzaher@med.au.edu.eg

01003133736

Other Identifiers

UAE in adenomyosis

Identifier Type: -

Identifier Source: org_study_id