Percutaneous Electrocoagulation Versus Sclerosing Foam for Patients With Incompetent Perforating Veins (PESIV)

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    84
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 7 October 2022

Summary

This study aimed to compare the efficacy of punctured electrocoagulation and sclerotherapy in the treatment of incompetent perforator veins.

Description

Background: Incompetent perforating vein (IPV) is one of the important causes of persistent venous ulcers of lower extremities and recurrence after operation of varices which is a hot button issue worth discussing in clinical practice. Minimally invasive surgery has become the trend of IPVs' treatment. Currently, sclerotherapy can be performed to treat incompetent perforating veins, which showed a 90% occlusion rate after three or fewer sessions, the recurrence was present nearly 1/3 of cases. While electrocoagulation has a reliable effect on the closure of incompetent perforating veins and simplify treatment. No comparative studies of different PAPS modalities are currently available. Therefore, this study aimed to compare the efficacy of punctured electrocoagulation and sclerotherapy in the treatment of incompetent perforating veins. Methods:This study is a multicenter, randomized controlled trial. We will recruit 84 patients with IPVs from five hospitals. Moreover, these patients will be randomized to either the experimental group (electrocoagulation) or the control group (sclerotherapy). The primary outcome is incompetent perforating veins occlusion rate in the 12th month. Secondary outcomes are quality of life scale survey results (CEAP classification, VCSS score, CIVIQ-14 score), skin ulcer recurrence rate, deep venous Thrombosis, hemorrhage, all-cause mortality, and other vascular events and serious complications.Discussion:This study will provide reliable, evidence-based clinical evidence for the efficacy of electrocoagulation therapy for incompetent perforating veins.

Details
Condition Incompetent Perforating Veins
Treatment treatment: puncture of coagulation, treatment: sclerosing agent injected
Clinical Study IdentifierNCT04686097
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

(1) outward flow of less than 500 ms duration, with a diameter of >3.5 mm; (2) According to
the CEAP classification method specified by the International Venous Federation, patients
with C4b~C6 grades are included

Exclusion Criteria

(1)age < 18 years or age > 80 years; (2)with malignant tumors and life expectancy < 1 year
(3)with past or current history of deep vein thrombosis and/or pulmonary embolism in the
lower extremities; (4)with congenital venous malformations (K-T syndrome, arteriovenous
fistula and etc.; (5)inability to walk, long-term braking, restrictive bed rest; severe
ischemia of lower extremities or diagnosed severity of peripheral artery occlusive disease
(6)according to the researcher's judgment, it is not suitable for foam hardener and
puncture coagulation treatment; (7)allergic to the drugs and equipment materials involved
in the research; (8)with inferior vena cava and/or iliac vein stenosis or occlusion
(9)with autoimmune disease, receiving chemotherapy, hormone therapy or immunomodulatory
treatment; (10)other underlying severe diseases; women who are pregnant, breastfeeding or
have pregnancy plans during the study period; (11)the patient cannot cooperate to complete
the inspection and follow-up required by the study
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