Study of Venous Outflow From the Lower Limbs in Patients With Pelvic Varicosities

NCT06124664 | Recruiting

• 1 other identifier: 012012548112
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Compression therapy is basic treatment for chronic venous disease (CVD) of the lower limbs. Numerous studies have demonstrated the efficacy and safety of compression therapy in relieving symptoms such as pain, venous edema, leg heaviness and fatigue, as well as accelerating the healing of venous ulcers. It has been established that сompression therapy is indicated for patients with both minimally expressed manifestations of CVD and severe forms of the disease. At the same only one study has been conducted to assess the correction of venous outflow from the lower limbs and pelvis in patients with pelvic varicose vein (PVV) and pelvic congestion syndrome (PCS). However, the incidence of this pathology ranges from 15 to 30% in the female population. The cost to the healthcare system of treating these patients in the United States exceeds $2 billion. To date, the options and indications for compression therapy in patients with concomitant PVV and CVD have not been defined. The rational use of compression in this cohort of patients may contribute to the improvement of effective conservative treatment. In addition, inappropriate prescription of compression to patients with pelvic venous disease (which can be observed in real clinical practice) may discredit this simple, effective and safe therapeutic method. In addition, the research devoted to the problem of compression treatment of PVV will contribute to the development of new special compression products aimed at accelerating venous outflow from the pelvic organs. It can be assumed that this will serve as a stimulus for obtaining new data on the therapeutic effects of compression and create conditions for the creation of new technological directions in the production of compression knitwear.

Conditions

Pelvic Varices; Varicose Veins of Lower Limb; Pelvic Pain Syndrome; Pelvic Congestive Syndrome

Keywords

pelvic varicose vein; venous outflow; chronic venous disease; compression treatment; duplex ultrasound; single-photon emission computed tomography

Outcome Measures

Primary Outcomes (2)

• The average transport time of the isotope

  Average transport time of the isotope is a value inversely proportional to the volumetric velocity of blood flow. The greater the average transport time of the isotope, the slower the speed of blood flow through the deep veins of the leg and vice versa. In addition, the linear speed of blood flow through the tibial veins is calculated. The data obtained allow us to judge the function of the MVP of the lower leg.

  Day 0 and Day 10

• coefficient of the pelvic venous congestion

  The computer equipment of the gamma camera allows you to calculate the number of pulses from the area of interest. The radiopharmaceutical radiation activity is recorded by the gamma camera in pulses per second. Pulse per second is a quantitative expression of the content of labeled red blood cells in the area of interest. Taking into account the different speed of blood flow in the pelvic veins in different patients and in order to objectify the data obtained, the ratio of pulse counts from 2 standard areas of interest is used - the veins of the uterus and parametrium and the common iliac vein on either side. This ratio is called coefficient of the pelvic venous congestion(Сpvc). The activity of labeled erythrocytes in this vessel is the most stable value. The activity of erythrocyte-phosphate-pertechnetate complexes in the venous plexuses depends on the presence of their varicose transformation and the deposition of blood in them.

  Day 0

Study Arms (3)

Symptomatic pelvic varicose veins (PVV)

40 patients will include patients with symptomatic PVV (pelvic pain, dyspareunia, heaviness in the hypogastrium) and without symptoms and signs of CVD.

Diagnostic Test: Radionuclide venography; Diagnostic Test: single-photon emission computed tomography

Asymptomatic PVV

40 pdtients will consist of women with asymptomatic PVV with signs of CVD.

Diagnostic Test: Radionuclide venography; Diagnostic Test: single-photon emission computed tomography

varicose veins of the lower limb

10 patients with varicose veins of the lower limb without PVV and pelvic congestion syndrome (PCS)

Diagnostic Test: Radionuclide venography; Diagnostic Test: single-photon emission computed tomography

Interventions

Radionuclide venography DIAGNOSTIC_TEST

With the patient in an upright position, 370 MBq of 99mTc pertechnetate is injected into one of the dorsal veins of the foot after applying a tourniquet in the area of the ankle joint. Then, with the help of a gamma camera detector, the movement of the radiopharmaceutical is monitored in the following segments: tibial (muscular-venous pump of the lower leg), popliteal, femoral and iliocaval. To study the evacuation function of the muscular-venous pump (MVP) of the leg, using an analytical computer program, areas of interest are identified in the tendon, muscle parts of the veins of the leg and the popliteal vein. The time of evacuation of the radiopharmaceutical from the MVP of the leg is estimated - the average transport time of the isotope.

Asymptomatic PVV; Symptomatic pelvic varicose veins (PVV); varicose veins of the lower limb

single-photon emission computed tomography DIAGNOSTIC_TEST

SPECT of the pelvic veins with in vivo-labelled red blood cells (RBCs). For radionuclide assessment of the state of the pelvic veins, 2 ml of Perfotech solution is injected into the cubital vein for subsequent "labeling" of red blood cells in vivo. In 20 minutes. 370 MBq of 99mTc-pertechnetate is injected into one of the veins of the dorsum of the foot and radionuclide venoscintigraphy is performed according to the method presented above. 20 minutes after the administration of the radiopharmaceutical and the venography, SPECT of the pelvic veins is performed. Tomography of the distribution of labeled erythrocytes in the pelvic veins is carried out in a circular orbit with the gamma camera detector rotated 360°. The analysis of the obtained information is carried out using the standard ECT Protocol software package, which allows obtaining sections in 3 projections (sagittal, transversal and coronal) with a slice step of 8 mm.

Asymptomatic PVV; Symptomatic pelvic varicose veins (PVV); varicose veins of the lower limb

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Patient age from 18 to 40 years and who regardless of their sex assigned at birth, identifies as a woman.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will consecutively include 90 female patients, including 80 patients with PVV and 10 patients without PVV. All patients will have a clinical examination and DUS of the veins of the pelvis and lower limbs, regardless of the presence or absence of clinical manifestations of diseases of the veins of the pelvis and lower limbs. Аll patients were performed radionuclide venography of the lower limbs and emission computed tomography (SPECT) of the pelvic veins with in vivo-labelled red blood cells (RBCs). Based on the results of radionuclide venography and SPECT, quantitative indicators of the work of the lower limbs MVP will be calculated (average transport time RPH) and Cpvc.

You may qualify if:

• Patient age from 18 to 40 years;
• Presence of pelvic varicose veins according to DUS data;
• Reflux in the pelvic veins for more than 1 second before this DUS;
• Reflux in the superficial veins of the lower limbs.

You may not qualify if:

• Menopause;
• Pregnancy;
• Postthrombotic disease;
• Suspicion of May-Turner syndrome;
• Ultrasound signs of nutcracker syndrome

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (1)

Ananstsia Grishenkova

Moskva, 119049, Russia

RECRUITING

Related Publications (7)

• Partsch H. Compression for the management of venous leg ulcers: which material do we have? Phlebology. 2014 May;29(1 suppl):140-145. doi: 10.1177/0268355514528129. Epub 2014 May 19.

  PMID: 24843100 RESULT

• Vin F, Benigni JP; International Union of Phlebology; Bureau de Normalisation des Industries Textiles et de l'Habillement; Agence Nationale d'Accreditation et d'Evaluation en Sante. Compression therapy. International Consensus Document Guidelines according to scientific evidence. Int Angiol. 2004 Dec;23(4):317-45. No abstract available.

  PMID: 15767979 RESULT

• Nicolaides A, Kakkos S, Eklof B, Perrin M, Nelzen O, Neglen P, Partsch H, Rybak Z. Management of chronic venous disorders of the lower limbs - guidelines according to scientific evidence. Int Angiol. 2014 Apr;33(2):87-208. No abstract available.

  PMID: 24780922 RESULT

• Gavrilov SG, Karalkin AV, Turischeva OO. Compression treatment of pelvic congestion syndrome. Phlebology. 2018 Jul;33(6):418-424. doi: 10.1177/0268355517717424. Epub 2017 Jun 22.

  PMID: 28639874 RESULT

• Gultasli NZ, Kurt A, Ipek A, Gumus M, Yazicioglu KR, Dilmen G, Tas I. The relation between pelvic varicose veins, chronic pelvic pain and lower extremity venous insufficiency in women. Diagn Interv Radiol. 2006 Mar;12(1):34-8.

  PMID: 16538582 RESULT

• Whiteley AM, Taylor DC, Dos Santos SJ, Whiteley MS. Pelvic venous reflux is a major contributory cause of recurrent varicose veins in more than a quarter of women. J Vasc Surg Venous Lymphat Disord. 2014 Oct;2(4):411-5. doi: 10.1016/j.jvsv.2014.05.005. Epub 2014 Jun 24.

  PMID: 26993547 RESULT

• Bora A, Avcu S, Arslan H, Adali E, Bulut MD. The relation between pelvic varicose veins and lower extremity venous insufficiency in women with chronic pelvic pain. JBR-BTR. 2012 Jul-Aug;95(4):215-21. doi: 10.5334/jbr-btr.623.

  PMID: 23019985 RESULT

MeSH Terms

Interventions

Tomography, Emission-Computed, Single-Photon

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Natalia V Koroleva, PhD

  Pirogov Russian National Research Medical University

  STUDY CHAIR

Central Study Contacts

Sergey G Gavrilov, MD, PhD

CONTACT

+79169299947; gavriloffsg@mail.ru

Anatoly V Karalkin, MD, PhD

CONTACT

+79166196821; avkrar@list.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: November 9, 2023
• Study Start: May 12, 2023
• Primary Completion: December 25, 2024
• Study Completion: December 25, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)