Pelvic Embolisation to Reduce Recurrent Varicose Veins - Primary

NCT ID: NCT01901731

Last Updated: 2014-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2018-10-31

Brief Summary

The aim of this study is to identify whether the treatment of pelvic venous reflux (pelvic coil embolisaton) in females with leg varicose veins, who have a proven contribution to their leg varicose veins from pelvic reflux, have a reduction in recurrence after varicose vein surgery.

Detailed Description

Varicose veins of the legs effect between 20 and 40% of the adult population in the UK. Approximately 100,000 operations performed per year for varicose veins. Failure to treat varicose veins results in 10 to 20% of patients deteriorating to skin damage or leg ulceration. Recurrence rates following surgery vary that have been reported up to 70% at 10 years.

The commonest causes of recurrence are reported to be:

• neovascularisation (new vessel growth after treatment)
• missing veins at the initial operation
• perforator vein incompetence
• de novo reflux due to normal deterioration with age

Recent studies have shown that leg varicose veins can be caused by pelvic venous reflux and that pelvic venous reflux is a cause of recurrent varicose veins. Previous published work from our own unit has shown that approximately 20% of women who present with varicose veins of the legs and who have had children previously have pelvic venous reflux on duplex ultrasound that contribute to the venous reflux in the legs, causing the varicose veins.

Furthermore, a recent retrospective study from our own unit has suggested that failure to treat pelvic venous reflux before treating leg varicose veins is a major cause of recurrent varicose veins in up to a quarter of women.

However, despite this circumstantial evidence, there is no evidence to prove whether the treatment of pelvic venous reflux confers any advantage on these patients in terms of reduction in recurrence of their varicose veins in the future.

The treatment of pelvic venous reflux is currently by coil embolisation of the veins under x-ray control. This procedure clearly has an additional cost over and above that of treating the legs. Therefore it is essential to know whether the treatment of the pelvic veins in these patients is any effect in reducing the recurrence of leg varicose veins.

To examine whether the addition of coil embolisation has significant benefits for patients, female patients presenting with primary leg varicose veins with a duplex proven contribution from pelvic venous reflux will be randomised to:

1. transjugular coil embolisation of pelvic veins followed by endovenous treatment of leg recurrent varicose veins or

2. endovenous treatment of leg recurrent varicose veins alone

The impact of demographic factors, the severity of patient's symptoms(Aberdeen questionnaire, CEAP and VCCS scores)and treatment history will be explored in addition to the type of treatment received.

Patients will be followed up at six weeks, six months, one year, two years, three years, four years and five years.

Assessments will be quality-of-life scoring (CIVIQ), symptom severity (Aberdeen questionnaire, CEAP and VCCS scores), patient satisfaction and clinical examination including clinical photographs, duplex ultrasonography.

In the presence of recurrent varicose veins, the source of these will also be classified through the use of duplex ultrasonography.

Conditions

Varicose Veins; Venous Reflux

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Embolisation of pelvic veins & treatment of leg varicose veins

Transjugular coil embolisation of pelvic veins followed by endovenous treatment of leg varicose veins

Group Type: EXPERIMENTAL

transjugular coil embolisation of pelvic veins

Intervention Type: PROCEDURE

endovenous treatment of leg varicose veins

Intervention Type: PROCEDURE

Endovenous treatment of leg varicose veins alone

Endovenous treatment of legs varicose veins only

Group Type: ACTIVE_COMPARATOR

endovenous treatment of leg varicose veins

Intervention Type: PROCEDURE

Interventions

transjugular coil embolisation of pelvic veins

Intervention Type: PROCEDURE

endovenous treatment of leg varicose veins

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Female gender
• Presenting with primary varicose veins in one or both legs with ultrasound --pelvic venous reflux in at least one trunk communicating with the leg varicose veins
• Over 18 years old
• Able to understand and give consent
• Willing to attend for follow ups over five year period

Exclusion Criteria

• Pelvic reflux does not communicate with the varicose veins to be treated in the legs
• If pelvic venous reflux communicates and contributes to varicose veins in one leg, but not the other, only the leg with a pelvic venous contribution will be entered into the study.
• Currently pregnant or plans for pregnancy in the next five years
• Under 18 years of age.
• Unable to understand or give consent.
• Any vascular malformation of the pelvis or legs, apart from that diagnosed as venous reflux disease.
• Any medical condition likely to cause death or serious ill health within the next five years.
• Any deep venous obstruction or reflux.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Whiteley Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Whiteley, Professor

Role: PRINCIPAL_INVESTIGATOR

The Whiteley Clinic

Locations

The Whiteley Clinic

Guildford, , United Kingdom

The Imaging Clinic

Guildford, , United Kingdom

Countries

United Kingdom

Central Contacts

Briony Hudson

Role: CONTACT

bh00047@surrey.ac.uk

01483 477180

Isabel Kay

Role: CONTACT

isabel@thewhiteleyclinic.co.uk

01483 477180

Facility Contacts

Mark Whiteley, Professor

Role: primary

mark@thewhiteleyclinic.co.uk

01483 477180

Isabel Kay

Role: backup

isabel@thewhiteleyclinic.co.uk

01483 477180

Tony Lopez, Bsc, MRCP, FRCR

Role: primary

Other Identifiers

RTC12013

Identifier Type: -

Identifier Source: org_study_id