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Coil EmbolizationNCT05085938

Complications of Gonadal Veins Embolization

An observational study of Coil Embolization and Pelvic Venous Disorders, run by Pirogov Russian National Research Medical University at 1 site in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years, women only
What is being tested?
gonadal vein embolization
How many people
150 participants
Where
1 siteRussia
Study dates
15 May 2021to 20 May 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • Adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Sergey Gavrilov, MD, PhD contact

+79168091193

lpl2@ya.ru

Oksana Efremova contact

+79168091193

lpl2@ya.ru

Russia1 site, 1 recruiting
  • Pirogov Russian National Research Medical University

    Moscow

    Oksana Efremova, PhD, +79168091193, lpl2@ya.ru

    Sergey Gavrilov, MD, PhD

    Recruiting

Other trials in Russia

About this study

Official title: The Frequency of Complication and Their Causes After Gonadal Vein Embolization by Coils in Patients With Pelvic Venous Diseases

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.

Read the detailed description

The aim of this study is to describe and study all side-effects and complications following embolization of gonadal veins.

This retrospective cohort study included 150 patients with PeVD who were treated by gonadal veins coil embolisation at the Savelyev University Surgical Clinic of the Pirogov Russian National Research Medical University in the period from 2000 to 2020. Patient informed consent was not required due to the retrospective nature of this study.

Inclusion criteria: 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; and gonadal veins coil embolization.

Exclusion criteria: 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.

The diagnosis of PeVD was verified by transvaginal and transabdominal DUS, multiplanar computed tomographic venography, ovarian venography.

All patients who have undergone embolization of gonadal veins with coils were collected in a special database. The data includes parameters that can provoke complications, such as weight, duration of surgery and hospitalization, pain level before and after procedures, and others.

Gonadal vein embolization with coils:

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 vein puncture was performed under ultrasound guidance. 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. When selecting the coil size, the principle of 20% coil oversizing relative to the GV diameter was used in order to avoid coil migration in the conductive veins and pulmonary artery. After embolization, the control ovarian venography was performed.

Assessment of the gonadal vein embolization complications:

Complications of GVE were graded according to the Society for Interventional Radiology (SIR) Adverse Event Classification System as follows: A - No therapy, no consequences; B - Nominal therapy, no consequence; includes overnight admission for observation only; C - Requires therapy, minor hospitalization (< 48 h); D - Requires major therapy, unplanned increase in level of care, prolonged hospitalization (> 48 h); E - Permanent adverse sequelae; F - Death. Minor complications include classes A and B, and major complications include classes C to F.

Complications of gonadal vein embolization with coils included:

  • Hematoma / bleeding at the access point;
  • Thrombosis of non-targeted pelvic veins (parametric, uterine, internal iliac veins);
  • Postembolization syndrome;
  • Protrusion of coils;
  • Migration of coils;
  • Allergic reactions to contrast agent or nickel. Complications of gonadal vein embolization with coils were assessed within 1-30 days and 12 month after procedure.

Primary Outcome Measure:

Change in the diameter of the pelvic veins

  • The diameter of the pelvic veins was measured using duplex ultrasound. [Time Frame: 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.

[Time Frame: 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.

[Time Frame: 1 day, 5 days, 1 and 12 months after the intervention on the pelvic veins.] • Pelvic vein thrombosis Pelvic vein thrombosis was detected using duplex ultrasound. [Time Frame: 1 and 5 days after the intervention on the pelvic veins]

Other Pre-specified Outcome Measures:

  • Complications of anesthesia Hematoma, vascular damage, pulmonary complications. [Time Frame: 1 and 5 days after the intervention on the pelvic veins]
Being tested
gonadal vein embolization
Keywords
pelvic venous disorders, gonadal veins embolization, complication after coil embolization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gonadal vein embolizationProcedure or surgery

    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.

Study groups in NCT05085938
Study groupRoleWhat they receive
Gonadal veins embolisationThis group includes patients who have undergone coil embolization of gonadal vein
Receives: Procedure: gonadal vein embolization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the diameter of the pelvic veins

    The diameter of the pelvic veins was measured using duplex ultrasound

    Measured: At baseline and 1-12 months after pelvic vein intervention

  2. 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

    Measured: At baseline and 1-12 months after pelvic vein intervention

  3. 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.

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

  4. Pelvic vein thrombosis

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

    Measured: 1 and 5 days after the intervention on the pelvic veins

Secondary outcomes (3)
  1. Hemorrhagic complications

    Hematoma or bleeding at the access poin

    Measured: 1 and 5 days after the intervention on the pelvic veins

  2. Other complications after embolisation

    Protrusion or migration of coils

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

  3. Allergic reactions

    Allergic reactions to contrast agent or nickel after procedure.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2021
  2. Study start15 May 2021
  3. Primary completion20 Apr 2022 (estimated)
  4. Study completion20 May 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05085938
Sponsor's protocol ID
Co-GAVE
Status last verified
Sep 2021
First submitted
7 Oct 2021
Last updated
3 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34200127
  • 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.

    PubMed 32932000
  • 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.

    PubMed 32464289

Questions about this trial

What is this clinical trial studying?

An observational study of Coil Embolization and Pelvic Venous Disorders, run by Pirogov Russian National Research Medical University at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sergey Gavrilov, MD, PhD (+79168091193, lpl2@ya.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the diameter of the pelvic veins (time frame: At baseline and 1-12 months after pelvic vein intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05085938, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.

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