Foam Plus Glue Versus Foam Plus Coils for Ovarian Vein Embolization in the Treatment of Pelvic Venous Disorders:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Kafrelsheikh University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- compare the clinical efficacy of ovarian vein embolization using combined foam plus N-butyl cyanoacrylate (Gluebran®️) versus combined foam plus detachable coils
Study Overview
Brief Summary
Foam Plus Glue Versus Foam Plus Coils for Ovarian Vein Embolization in the Treatment of Pelvic Venous Disorders: A Randomized Controlled Trial
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female patients aged 18 to 50 years
- •Clinically suspected pelvic venous disorder (PVD), presenting with chronic pelvic pain ≥ 6 months
- •Pelvic pain intensity ≥ 4 on a 10-point Visual Analogue Scale (VAS) at baseline
- •No evidence of significant venous obstruction or internal iliac insufficiency
- •Willingness to participate, provide written informed consent, and comply with study visits and procedures
Exclusion Criteria
- •Pregnancy or planning to conceive within the next 12 months
- •Significant Nutcracker syndrome diagnosed by duplex / CTV / MRV
- •Significant May-Thurner syndrome diagnosed by duplex / CTV / MRV
- •Non-ovarian sources of reflux requiring intervention, including internal iliac vein insufficiency; During venography all patients will undergo selective pelvic venography prior embolization to exclude patients who have combined gonadal and internal iliac vein reflux)
- •History of previous pelvic vein embolization or surgical ligation
- •Coagulopathy, defined as:
- •INR > 1.5
- •Platelet count < 50 × 10⁹/L
- •Severe comorbidities, including:
- •Active pelvic infection (e.g., pelvic inflammatory disease)
- •End-stage renal disease (eGFR < 30 mL/min/1.73 m²)
- •Decompensated heart failure (NYHA class III-IV)
- •Active malignancy requiring treatment
- •Known allergy or hypersensitivity to:
- •Iodinated contrast media
- •Polidocanol (Aethoxysklerol®)
- •N-butyl cyanoacrylate (e.g., Gluebran® 2)
- •Nickel, platinum, or stainless steel (components of embolization coils) . Presence of non-venous pelvic pathology requiring immediate management
Arms & Interventions
Embolization using polidocanol foam followed by N-butyl cyanoacrylate
. After selective catheterization of the ovarian vein and reflux confirmation, Sclerosant foam will be prepared using 3% polidocanol (Aethoxysklerol®, Kreussler Pharma), mixed with room air in a 1:4 ratio (1 mL polidocanol to 4 mL air) using the Tessari double-syringe technique, creating a dense and stable foam. The foam will be injected slowly into the reservoir of the refluxing segment of the ovarian vein under fluoroscopic guidance to induce endothelial irritation and reduce venous flow. A total of 5-10 mL of 3% polidocanol foam will be injected per vein, adjusted based on vein diameter and reflux length.
Next, N-butyl cyanoacrylate (Gluebran®️ 2) will be mixed with Lipiodol in a 1:2 to 1:3 ratio, depending on vein size and flow rate. Approximately 1-2 mL of the glue mixture will be injected per vein using a coaxial microcatheter system from distal to proximal segments. Occlusion will be confirmed by post-embolization venography."
Intervention: Foam + N-butyl Cyanoacrylate (Other)
Combined Foam Sclerotherapy and Detachable Coil Embolization
Patients in this group will undergo embolization using sclerosant foam followed by detachable platinum coils. Vascular access and catheterization technique will mirror Group A.
After injecting polidocanol foam (as above), subsequently, detachable platinum fibered coils - specifically Interlock™ (Boston Scientific) or Concerto™ (Medtronic) - will be deployed to achieve permanent mechanical occlusion. Coil selection (diameter and length) will be based on intra-procedural vein sizing. Final occlusion will be confirmed via completion venography.
Intervention: Combined Foam Sclerotherapy and Detachable Coil Embolization (Other)
Outcomes
Primary Outcomes
compare the clinical efficacy of ovarian vein embolization using combined foam plus N-butyl cyanoacrylate (Gluebran®️) versus combined foam plus detachable coils
Time Frame: 18 months
2\. Symptom severity reduction, assessed by the Pelvic Venous Clinical Severity Score (PVCSS) at baseline, 3, 6, 12, and 18 months.
Secondary Outcomes
No secondary outcomes reported
Investigators
Moustafa Hassan Mabrouk Abdelhameed
principal investigator
Kafrelsheikh University