Balloon Test for Iliac Vein Compression

NCT02584374 | Unknown

• 1 other identifier: NL54330
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

May-thurner Syndrome

Keywords

iliac vein compression

Outcome Measures

Primary Outcomes (1)

• Presence of collaterals (prevalence number)

  During regular venography the presence and amount of collaterals are scored. Collaterals need to cross the midline to be considered positive. Subsequently, balloon occlusion of the left common iliac vein will be performed and another contrast injection will take place. The presence and amount of collaterals will again be assessed. Quantitive analysis will be performed to evaluate the amount of collaterals and how they are branched off.

  During venography

Study Arms (2)

Patients

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

Other: Venography with balloon occlusion test

Healthy controls

Healthy subjects between 18-45 years of age Venography with balloon occlusion test will be performed.

Other: Venography with balloon occlusion test

Interventions

Venography with balloon occlusion test 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; Patients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers (all patients who have been diagnosed using this technique will be used as a comparison group)

You may qualify if:

• Healthy volunteers (all patients who have been diagnosed using this technique will be used as a comparison group)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre+

Maastricht, Netherlands

RECRUITING

MeSH Terms

Conditions

May-Thurner Syndrome

Condition Hierarchy (Ancestors)

Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Peripheral Vascular Diseases; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• R de Graaf, MD, PhD

  Maastricht UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ralph LM Kurstjens, MD

CONTACT

+31433881558; r.kurstjens@maastrichtuniversity.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 22, 2015
• Study Start: January 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: January 22, 2016

Record last verified: 2015-10

Locations

NL (1)