Ignite Creation Date:
2024-05-06 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05085938
Status:
UNKNOWN
Last Update Posted:
2022-02-03
First Post:
2021-10-07
Brief Title:
Complications of Gonadal Veins Embolization
Sponsor:
Pirogov Russian National Research Medical University
Organization:
Pirogov Russian National Research Medical University
Study Overview
Official Title:
The Frequency of Complication and Their Causes After Gonadal Vein Embolization by Coils in Patients With Pelvic Venous Diseases
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
In this study it is planned to conduct a retrospective analysis of patients database who have undergone gonadal veins embolization with nitinol coils
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 discomfortheaviness 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 50-100 mL of 05 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 0035 standard stainless steel coils Gianturco William Cook Bjæverskov Denmark and 0035 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
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 discomfortheaviness 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 50-100 mL of 05 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 0035 standard stainless steel coils Gianturco William Cook Bjæverskov Denmark and 0035 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None