Balloon Test for Iliac Vein Compression

NCT ID: NCT02584374

Last Updated: 2016-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-03-31

Brief 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.

Detailed 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.

Conditions

May-thurner Syndrome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

with suspected iliac vein compression, but with no signs of compression on venography and if venography with balloon occlusion test is performed.

Venography with balloon occlusion test

Intervention Type: OTHER

First, regular venography of the venous iliac tract will be performed. Second, a 16mm diameter balloon will be inflated in the common iliac vein and venography will be repeated.

Healthy controls

Healthy subjects between 18-45 years of age

Venography with balloon occlusion test will be performed.

Venography with balloon occlusion test

Intervention Type: OTHER

First, regular venography of the venous iliac tract will be performed. Second, a 16mm diameter balloon will be inflated in the common iliac vein and venography will be repeated.

Interventions

Venography with balloon occlusion test

First, regular venography of the venous iliac tract will be performed. Second, a 16mm diameter balloon will be inflated in the common iliac vein and venography will be repeated.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

R de Graaf, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht UMC

Locations

Maastricht University Medical Centre+

Maastricht, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Ralph LM Kurstjens, MD

Role: CONTACT

r.kurstjens@maastrichtuniversity.nl

+31433881558

Facility Contacts

R Kurstjens

Role: primary

Other Identifiers

NL54330

Identifier Type: -

Identifier Source: org_study_id