Flush Versus Standard Distance From Saphenofemoral Junction in Endovenous Laser Ablation of Great Saphenous Vein (fEVLA)

March 29, 2025 updated by: Ahmed Abdullah Yahya Mohamed Fouda, Kafrelsheikh University
Varicose veins of the great saphenous vein (GSV) are a prevalent venous disorder, with higher incidence in women. They cause swelling, pain, ulcers, eczema, and phlebitis, impacting patients' occupational performance and quality of life. Endovenous laser ablation (EVLA) has been supplanted by high-level laser surgery (HLS) as the primary treatment for incompetent GSVs. EVLA uses laser energy to generate heat, altering or inactivating proteins and enzymes within the vessel wall. Occlusion rates are shown to be around 95% after one year. However, the influence of the untreated proximal segment adjacent to the sapheno-femoral junction (SFJ) on reflux and recurrence is ambiguous. Contemporary laser fibers, such as radially emitting fibers, can reduce postoperative discomfort and improve outcomes. However, data on the safety and long-term outcomes of flush ablation compared to standard ablation remains insufficient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Varicose veins of the great saphenous vein (GSV) represent one of the most prevalent venous disorders, with a higher incidence in women compared to men. The manifestations of varicose veins include not only swelling and pain in the lower extremities but are frequently associated with ulcers, eczema, phlebitis, and other detrimental effects, resulting in an irreversible impact on patients' occupational performance and quality of life. To enhance this, it is essential to investigate appropriate treatments for clinical implementation (3). Current guidelines indicate that EVLA and other endovenous thermal ablation techniques have supplanted HLS as the primary treatment for incompetent saphenous veins, due to their demonstrated efficacy in numerous countries. In the EVLA treatment, laser energy is introduced into the lumen of the blood vessel, generating heat that alters or inactivates the proteins and enzymes within the vessel wall. Following the destruction of the vein wall's structure, the vein exhibits fibrosis, resulting in the contraction and permanent occlusion of the blood vessels. Endovenous laser ablation (EVLA) is an efficacious technique for addressing incompetent great saphenous veins (GSV) (5, 6, 7). Occlusion rates were shown to attain approximately 95% after one year (5). Notwithstanding favorable outcomes regarding the occlusion rate, the influence of the untreated proximal segment adjacent to the sapheno-femoral junction (SFJ) on the onset of reflux and recurrence following thermal ablation remains ambiguous (8, 9, 10, 11). Increased incidences of stump reflux following EVLA have been documented in comparison to high ligation and stripping (8, 9). Flessenkämper et al. demonstrated a significantly higher incidence of reflux from the SFJ into the GSV following EVLA alone compared to high ligation and stripping (HL/S) and HL plus EVLA (8). Rass et al. reported a 17.8% incidence of reflux in the GSV stump following EVLA and a 1.3% incidence after HL/S (9). The authors consequently reported a greater incidence of recurrent varicose veins in the groin compared to high ligation/stripping after five years (9). Contemporary laser fibers, such as radially emitting fibers, can diminish postoperative discomfort and enhance outcomes (12, 13). A modified radial fiber emits laser energy in two distinct rings radially around the tip. This is believed to produce a more uniform thermal effect on the venous wall, resulting in reduced pain and bruising post-procedure (14). These fibers facilitate the ablation of the GSV near the SFJ and may yield results comparable to high ligation (15). A comparable effect can be achieved with the 1-ring fiber, exhibiting a slightly elevated linear energy density (LEED) at the junction with the deep vein. This study will utilize the 2-ring fiber, as we favor a marginally diminished LEED at the tip to mitigate the risk of injury to the deep vein. Regrettably, data regarding the safety and long-term outcomes of flush ablation in comparison to standard ablation remain insufficient.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Kafrelsheikh, Egypt, 08532
        • Kafrelsheikh University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age 18-60 years.
  • patients with CEAP classes C2 to C6
  • primary great saphenous vein insufficiency with at least 0.5 seconds of reflux in the standing position on color Doppler ultrasound.

Exclusion Criteria:

  • deep or superficial venous thrombosis
  • previous treatment of the varicose veins
  • severe infection in the ipsilateral lower limb
  • GSV diameter more than15 mm or less than 3 mm
  • ipsilateral lower limb arterial stenosis or occlusion;
  • pregnancy or breastfeeding;
  • iliac vein compression syndrome.
  • congenital venous anomalies
  • allergy to lidocaine
  • Debilitating systemic disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: flush EVLA
The fiber tip was positioned in fEVLA group Flush at SFJ
Procedure: flush endovenous laser ablation of great saphenous vein
A 4 French sheath is advanced over the wire and positioned in the great saphenous vein below knee. Diode laser (SmartM; Lasotronix) with a 600-mm radial fiber catheter was used. The tip of the laser was be placed flush at saphenofemoral junction.
Active Comparator: standard EVLA
The fiber tip was positioned in sEVLA group 2 cm distal to SFJ
Procedure: standard endovenous laser ablation of great saphenous vein
A 4 French sheath is advanced over the wire and positioned in the great saphenous vein below knee. Diode laser (SmartM; Lasotronix) with a 600-mm radial fiber catheter was used. The tip of the laser was be placed 2 cm distal to saphenofemoral junction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
occlusion rate
Time Frame: 1 year
1-percentage of treated veins that remain closed or occluded (blocked) following the EVLA. It is an important measure of the treatment's effectiveness in permanently sealing the vein, preventing blood flow through ablated area.
1 year
endovenous heat induced thrombosis
Time Frame: 1 year
formation of a blood clot at saphenofemoral junction caused by heat from endovenous laser ablation of great saphenous vein
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications
Time Frame: 1 year
Procedure-related complications, such as deep venous thrombosis in locations other than the SFJ or CFV, superficial vein thrombosis, pulmonary embolism, allergy, sensory disturbance in the groin region, bleeding, and infection
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kafrelsheikh University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2024

Primary Completion (Actual)

February 20, 2025

Study Completion (Actual)

March 20, 2025

Study Registration Dates

First Submitted

March 23, 2025

First Submitted That Met QC Criteria

March 29, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

March 29, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KFSIRB200-278
  • MUka12 (Other Identifier: Cairo university)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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