Balloon Test for Iliac Vein Compression

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Rationale: 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 the investigators' 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.

Objective: The objective of this study is to identify whether venography with balloon occlusion of the common iliac vein has value in the diagnosis of iliac vein compression syndrome.

Study design: This is an observational study in healthy subjects compared to a patient population with suspected iliac vein compression.

Study population: Healthy subjects between the ages of 18 and 45 and patients with suspected iliac vein compression who show no signs of compression on venography.

Diagnostic test: Subjects will undergo a diagnostic phlebography, during which the common iliac vein is occluded by balloon inflation and contrast is injected to identify whether a network of pelvic collaterals will appear.

Main study parameters/endpoints: The main endpoint of this study is the presence of collaterals that cross the midline after balloon occlusion of the left common iliac vein, which is scored as present or not Additionally, a quantitive analysis of collaterals will be performed. ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

May-thurner Syndrome

Clinical Trial Details

NCT number	NCT02584374
Study type	Observational
Source	Maastricht University Medical Center
Contact	Ralph LM Kurstjens, MD
Phone	+31433881558
Email	r.kurstjens@maastrichtuniversity.nl
Status	Recruiting
Phase	N/A
Start date	January 2016
Completion date	March 2016

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.