Complications of Gonadal Veins Embolization

NCT05085938 | Unknown DMC

• 1 other identifier: Co-GAVE
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pelvic venous disorders; gonadal veins embolization; complication after coil embolization

Outcome Measures

Primary Outcomes (4)

• Change in the diameter of the pelvic veins

  The diameter of the pelvic veins was measured using duplex ultrasound

  At baseline and 1-12 months after pelvic vein intervention

• Change in the duration of pelvic venous reflux

  Pelvic venous reflux was measured using duplex ultrasound. Reflux duration of more than 1 s was considered pathological

  At baseline and 1-12 months after pelvic vein intervention

• Postprocedural pain

  The visual analogue scale is a line 10 cm long. Each centimeter corresponds to 1 point: 0 points - no pain, 10 points - maximum pain. Higher scores on the scale correspond to poorer results.

  1 day, 5 days, 1 and 12 months after the intervention on the pelvic veins

• Pelvic vein thrombosis

  Thrombosis of non-targeted pelvic veins (parametric, uterine, internal iliac veins). Pelvic vein thrombosis was detected using duplex ultrasound

  1 and 5 days after the intervention on the pelvic veins

Secondary Outcomes (3)

• Hemorrhagic complications

  1 and 5 days after the intervention on the pelvic veins

• Other complications after embolisation

  1 day, 5 days, 1 and 12 months after coil embolization

• Allergic reactions

  1 day, 5 days, 1 and 12 months after coil embolization

Other Outcomes (1)

• Complications of anesthesia

  1 and 5 days after the intervention on the pelvic veins

Study Arms (1)

Gonadal veins embolisation

This group includes patients who have undergone coil embolization of gonadal vein

Procedure: gonadal vein embolization

Interventions

gonadal vein embolization PROCEDURE

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.

Gonadal veins embolisation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Cohort includes 150 women who have undergone gonadal vein embolisation or endoscopic resection

You may qualify if:

• the presence of symptoms and signs of PeVD (pelvic venous pain, dyspareunia, discomfort/heaviness in the hypogastric region, vulvar varicosities);
• reflux in the gonadal, parametrial, uterine veins according to duplex ultrasound and ovarian venography;
• gonadal veins embolization with coils.

You may not qualify if:

• the presence of nutcracker and May-Thurner syndromes, confirmed by multiplanar renal and pelvic venography;
• open, endoscopic, or hybrid interventions on the gonadal and iliac veins or pelvic organs.

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (1)

Pirogov Russian National Research Medical University

Moscow, Russia

RECRUITING

Related Publications (3)

• Gavrilov SG, Krasavin GV, Mishakina NY, Efremova OI, Zolotukhin IA. The Effect of Venoactive Drug Therapy on the Development and Severity of Post-Embolization Syndrome in Endovascular Interventions on the Gonadal Veins. J Pers Med. 2021 Jun 7;11(6):521. doi: 10.3390/jpm11060521.

  PMID: 34200127 BACKGROUND

• Gavrilov SG, Krasavin GV, Mishakina NY, Kirsanov KV. Postembolization syndrome in endovascular interventions on the gonadal veins. J Vasc Surg Venous Lymphat Disord. 2021 May;9(3):697-702. doi: 10.1016/j.jvsv.2020.09.003. Epub 2020 Sep 12.

  PMID: 32932000 BACKGROUND

• Gavrilov SG, Sazhin A, Krasavin G, Moskalenko E, Mishakina N. Comparative analysis of the efficacy and safety of endovascular and endoscopic interventions on the gonadal veins in the treatment of pelvic congestion syndrome. J Vasc Surg Venous Lymphat Disord. 2021 Jan;9(1):178-186. doi: 10.1016/j.jvsv.2020.05.013. Epub 2020 May 25.

  PMID: 32464289 BACKGROUND

Central Study Contacts

Sergey Gavrilov, MD, PhD

CONTACT

+79168091193; lpl2@ya.ru

Oksana Efremova

CONTACT

+79168091193; lpl2@ya.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: October 20, 2021
• Study Start: May 15, 2021
• Primary Completion: April 20, 2022
• Study Completion: May 20, 2022
• Last Updated: February 3, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)