UnknownNot Applicable

Balloon Test for Iliac Vein Compression

Netherlands20 participantsStarted 2016-01

Plain-language summary

Iliac vein compression is a common cause of leg or abdominal complaints and is difficult to diagnose. Although a combination of duplex ultrasonography, magnetic resonance venography and two-plane phlebography are able to show compression, not all suspected iliac vein compressions can be identified. Intravascular ultrasound appears to have a higher diagnostic value, but is far more expensive. In our experience a balloon occlusion test in the common iliac vein during phlebography can diagnose iliac vein compression due to the collateral network that is visualised. The general consensus is that pelvic collaterals are a sign of pathology, though the investigators would like to validate this test by showing that a balloon occlusion test in healthy subjects does not identify a collateral network.

Who can participate

Age range18 Years – 45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy volunteers (all patients who have been diagnosed using this technique will be used as a comparison group) Exclusion Criteria: * Disease affecting the circulatory system, such as cardiac disease, varicosities or peripheral arterial disease, on the basis of anamnesis. * History of bleeding or clotting disorders * Complaints of the abdomen or leg consistent with iliac vein compression syndrome or pelvic congestion syndrome * Clinical-Etiologic-Anatomic-Pathophysiologic classification of C2 or higher (C0: no venous signs, C1: venectasia, C2: varicose veins, C3: edema, C4: skin changes, C5 healed ulcer, C6: active ulcer) * History of deep venous thrombosis or pulmonary embolism. * History of surgery of the abdomen, groin or lower limb * Pregnancy * Allergy to contrast or lidocaine * Active malignancy * (For the patient comparison group: obvious signs of compression on venography without balloon occlusion test)

What they're measuring

Presence of collaterals (prevalence number)

Timeframe: During venography

Trial details

NCT IDNCT02584374

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-03

Contact for this trial

Ralph LM Kurstjens, MD

+31433881558 r.kurstjens@maastrichtuniversity.nl