The objective of this study is to identify whether pelvic collateralisation occurs when a temporary acute obstruction is induced in the left common iliac vein of healthy subjects.
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of this study is the presence of collaterals (passing the
midline) after balloon occlusion of the left common iliac vein, which is scored
as present or not. (also location and amount if present and expressed as a
prevalence percentage)
Secondary outcome
Demographic characteristics
Background 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 we would like to validate this test
by showing that a balloon occlusion test in healthy subjects does not identify
a collateral network.
Study objective
The objective of this study is to identify whether pelvic collateralisation
occurs when a temporary acute obstruction is induced in the left common iliac
vein of healthy subjects.
Study design
This is a diagnostic study in healthy subjects.
Study burden and risks
The patient can experience some pain and could develop some minor bleeding in
the form of a bruise. An allergic reaction is less likely and risk of
thrombosis or severe bleeding is highly unlikely
P. Debyelaan 25
Maastricht 6202 AZ
NL
P. Debyelaan 25
Maastricht 6202 AZ
NL
Listed location countries
Age
Inclusion criteria
Age 18 - 45 years
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
- CEAP 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT???(pending) |
| CCMO | NL54330.068.15 |