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

CompletedOBSERVATIONAL
Enrollment

400

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

January 30, 2023

Study Completion Date

February 11, 2023

Conditions
Pelvic Venous DisordersPelvic Congestive SyndromeMay-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."

Trial Locations (1)

119049

Department of Faculty Surgery №1, Moscow

All Listed Sponsors
lead

Pirogov Russian National Research Medical University

OTHER

NCT05076448 - The Efficacy and Safety of Interventions on the Pelvic Veins in Pelvic Venous Disorders | Biotech Hunter | Biotech Hunter