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Complications of Gonadal Veins Embolization

NCT05085938 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2022-02-03

No results posted yet for this study

Summary

Gonadal veins embolization (GVE) with nitinol or platinum coils is widely used in the treatment of PeVD caused by the valvular incompetence of gonadal, parametrial, and uterine veins. Most authors report a high efficacy of this technique in reducing blood flow through the gonadal veins (GV) and relieving symptoms of the disease. In the Society for Vascular Surgery (SVS) and American Venous Forum (AVF) guidelines, GVE is considered the standard of treatment for PeVD with a grade of recommendation 2B, due to the moderate quality of evidence. Moreover, other studies report about wide variability in the GVE outcomes, in terms of pelvic venous pain (PVP) elimination, persistence or intensification of pain after GVE, and coil migrations and protrusions. It is known that 6% to 32% of patients do not achieve significant pain relief after the procedure. The most studies of GVE in the treatment of PeVD are characterized by only a statement of the fact of any complication without investigating the causes of its development. At the same time, it is well known that it is a thorough study of complications that makes it possible to avoid failures in the future, to improve the therapeutic technique, or to abandon its use altogether.

In this study, it is planned to conduct a retrospective analysis of patients' database, who have undergone gonadal veins embolization with nitinol coils.

Conditions

  • Coil Embolization
  • Pelvic Venous Disorders
  • Gonadal Veins Insufficiency
  • Pelvic Venous Pain

Interventions

PROCEDURE

gonadal vein embolization

GVE was performed under local anesthesia with 5.0-10.0 mL of 0.5% lidocaine solution with a patient under intravenous sedation. For the left GV embolization, the transfemoral approach was used, while for the right or both GV embolization, the transjugular approach was used. The 5F multipurpose angiographic catheters (Cordis; USA), standard 'moving core' J .035" guidewire, and an angled hydrophilic guidewire (Radiofocus; Terumo Corp., Japan) were used. For the GV occlusion, the pushable 0.035" standard stainless steel coils (Gianturco; William Cook, Bjæverskov, Denmark) and 0.035" coils made of Inconel with interwoven long collagen fibrils (MReye; Cook Medical Inc., Bloomington, USA) were used. The diameter of coils was 8-12 mm, and the length was 10-20 cm.

Sponsors & Collaborators

  • Pirogov Russian National Research Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-15
Primary Completion
2022-04-20
Completion
2022-05-20

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05085938 on ClinicalTrials.gov