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

Percutaneous Electrocoagulation Versus Sclerosing Foam for Patients With Incompetent Perforating Veins : A Multi-center Prospective Randomized Controlled Trial

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

Study Overview

• Status: Recruiting
• Conditions: Incompetent Perforating Veins
• Intervention / Treatment: Procedure: treatment: puncture of coagulation; Procedure: treatment: sclerosing agent injected

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhen jie Liu; Phone Number: 86-0571-87913706; Email: lawson4001@zju.edu.cn

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Suspended
      • Anhui Provincial Hospital
  • Shandong
    • Yantai, Shandong, China, 264000
      • Suspended
      • Yantai Yuhuangding Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Suspended
      • Zhongshan Hospital Affiliated to Fudan University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Zhenjie Liu; Phone Number: 86 15268135830; Email: lawson4001@zju.edu.cn
    • Hangzhou, Zhejiang, China, 310000
      • Suspended
      • Sir Run Run Shaw Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: experimental group (electrocoagulation); Participants in the experimental group will receive ultrasound-guided puncture of coagulation incompetent perforator veins.	Procedure: treatment: puncture of coagulation; ultrasound-guided puncture of coagulation
ACTIVE_COMPARATOR: control group (sclerotherapy); Participants in the control group will receive an ultrasound-guided sclerosing agent injected.	Procedure: treatment: sclerosing agent injected; ultrasound-guided sclerosing agent injected

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IPVs occlusion rate in the 12th month.	IPVs occlusion rate is defined as DS > 50% for each modality with no procedure no procedure performed on the treated segment	12 months after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life scale survey results	quality of life scale survey results (CEAP classification, VCSS score, CIVIQ-14 score).Quality of life will be assessed by MOS item short-form health survey scale (SF-36). SF-36 includes eight subscales: physical functioning (PF, 10 items), role limitations due to physical health problems (RL-P, 4 items), bodily pain (BP, 2 items), general health (GH, 5 items), vitality (V, 4 items), social functioning (SF, 2 items), role limitations due to emotional problems (RL-E, 3 items) and mental health (MH, 5 items). The vitality sub-score assesses energy and fatigue, and ranges from 0 (worst) - 100 (best).	1-month,6-month,12-month
Skin ulcer recurrence rate	Skin ulcer recurrence	1-month,6-month,12-month
Proportion of participants with deep venous Thrombosis	deep venous Thrombosis	1-month,6-month,12-month
Proportion of participants with hemorrhage	Including hemorrhagic stroke, gastrointestinal bleeding, hematuria, mucocutaneous hemorrhage and other visceral bleeding	1-month,6-month,12-month
All-cause mortality and other vascular events and serious complications.	Percentage of participants with all deaths	1-month,6-month,12-month

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Shanghai Zhongshan Hospital; Sir Run Run Shaw Hospital; Anhui Provincial Hospital; Yantai Yuhuangding Hospital
• Investigators: Principal Investigator: Zhen jie Liu, MD,PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

General Publications

• Cooper DG, Hillman-Cooper CS, Barker SG, Hollingsworth SJ. Primary varicose veins: the sapheno-femoral junction, distribution of varicosities and patterns of incompetence. Eur J Vasc Endovasc Surg. 2003 Jan;25(1):53-9. doi: 10.1053/ejvs.2002.1782.
• Sakurai T, Matsushita M, Nishikimi N, Nimura Y. Hemodynamic assessment of femoropopliteal venous reflux in patients with primary varicose veins. J Vasc Surg. 1997 Aug;26(2):260-4. doi: 10.1016/s0741-5214(97)70187-3.
• Guex JJ. Ultrasound guided sclerotherapy (USGS) for perforating veins (PV). Hawaii Med J. 2000 Jun;59(6):261-2. No abstract available.
• Masuda EM, Kessler DM, Lurie F, Puggioni A, Kistner RL, Eklof B. The effect of ultrasound-guided sclerotherapy of incompetent perforator veins on venous clinical severity and disability scores. J Vasc Surg. 2006 Mar;43(3):551-6; discussion 556-7. doi: 10.1016/j.jvs.2005.11.038.
• Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079.
• Hager ES, Washington C, Steinmetz A, Wu T, Singh M, Dillavou E. Factors that influence perforator vein closure rates using radiofrequency ablation, laser ablation, or foam sclerotherapy. J Vasc Surg Venous Lymphat Disord. 2016 Jan;4(1):51-6. doi: 10.1016/j.jvsv.2015.08.004.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ANTICIPATED): December 30, 2023
• Study Completion (ANTICIPATED): December 30, 2023

Study Registration Dates

• First Submitted: December 23, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (ACTUAL): December 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Sclerotherapy; Venous ulcer; Venous disease; Perforating veins; Electrocoagulationt
• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Sclerosing Solutions
• Other Study ID Numbers: SAHZhejiangU-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No