The Efficacy and Safety of Interventions on the Pelvic Veins in Pelvic Venous Disorders

Summary

This study includes a retrospective and prospective study will enroll patients with pelvic venous disorders who have undergone pelvic vein surgery and endovascular interventions. Three groups of patients will be formed. The first will include patients who underwent open retroperitoneal resection of the gonadal veins and endoscopic trans- and retroperitoneal resection of the gonadal veins. The second group will include patients who underwent embolization of the gonadal veins with coils, the third - patients who underwent stenting of the common iliac veins, or stenting of the iliac veins in combination with embolization of the gonadic veins with coils. Evaluation of the effectiveness and safety of interventions on the pelvic veins will be carried out by assessing the effect of the intervention on pelvic pain, morphological and functional state of the pelvic veins. The assessment of the safety of interventions on the pelvic veins will be carried out by assessing the severity of post-procedural pain, the frequency of complications of operations on the pelvic veins, and complications of anesthesia. In addition, the duration of pelvic vein interventions will be compared with the length of time the patient is in hospital. Based on the data obtained, an algorithm will be proposed for determining the choice of the method of interventions on the pelvic veins in patients with pelvic venous disorders.

Conditions

• Pelvic Venous Disorders
• Pelvic Congestive Syndrome
• May-Thurner Syndrome

Interventions

PROCEDURE

Gonadal veins resection

Gonadal veins resection (GVR) was performed open, transperitoneal and retroperitoneal endoscopic methods under general anesthesia. Open GVR was performed in the Trendelenburg position, on the back with the operating table rotating 30° The retroperitoneal approach was employed in the left and/or right iliac region. The GV was mobilized for 10-12 cm and the vein was resected.. Transperitoneal GVR was performed with 3 ports were placed: one 10-mm port in the umbilical region, one 5-mm port in the left or right iliac region, and one 5-mm port 5 cm below the umbilicus. The GV was mobilized over a length of 10-12 cm and the vessel was resected. Retroperitoneal GVR was performed with the patient in a lateral position and in the reverse Trendelenburg position. A 10-mm camera port was installed in the lumbar region between the posterior superior iliac spine and the lower edge of the XII rib. The GV was mobilized over a length of 10-12 cm and the vessel was resected.

PROCEDURE

Gonadal vein embolization with coils

Procedure 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.

PROCEDURE

Endovascular stenting of the common iliac vein (CIV)

After providing local anesthesia, the left common femoral vein was punctured, a 0.035" guidewire was inserted into the inferior vena cava (IVC), and then a 10F introducer was installed. A balloon catheter was introduced over the guidewire in the left CIV (XXL balloon, Boston Scientific, diameter 14-18, length 40-60 mm), and double balloon dilation of the vessel was performed with a pressure of 6-8 atm. Then, a delivery system was advanced to the area of stenosis in the left CIV, and stent was deployed at the level of confluence of the left CIV and inferior vena cava (IVC) or with a protrusion in the IVC of no more than 1 cm. For better fixation of stent in the venous lumen and prevention of its displacements and migration, a balloon post-dilatation of the stented vessel was performed. In case of residual stenosis, the balloon angioplasty was performed.

Sponsors & Collaborators

• Pirogov Russian National Research Medical University

  lead OTHER

Principal Investigators

• Natalia V Koroleva, PhD · Pirogov Russian National Research Medical University

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-09-30

Primary Completion

2023-01-30

Completion

2023-02-11

Countries

• Russia

Study Locations