Clinical trial NCT03835559: Cyanoacrylate Closure Versus Surgical Stripping for Incompetent Saphenous Veins
Official title: Randomized Controlled Trial Comparing the Clinical Outcomes After Cyanoacrylate Closure and Surgical Stripping for Incompetent Saphenous Veins
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Occlusions Vein
Chronic Venous Insufficiency
Keywords: varicose vein
stripping
endovenous
ablation
Occlusion
quality of life
Lead sponsor: Kyung Hee University Hospital at Gangdong
Sponsor class: OTHER
First posted: 2019-02-08
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, prospective randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the non-inferior, clinical outcomes after cyanoacrylate closure comparing the surgical stripping for incompetent saphenous veins.

Detailed description: Varicose veins are highly prevalent. In western countries, an estimated 23% of adults have varicose veins, and 6% have more advanced chronic venous disease, including skin changes and healed or active venous ulcers. There are several modalities to treat varicose veins. Open surgical treatment with ligation and stripping of the saphenous vein, combined with excision of large varicosities, has been the standard of care for many years. Endovenous thermal ablation by radiofrequency ablation (RFA) or endovenous laser ablation (EVLA) has been shown to be a safe and effective alternatives with high long-term target vein closure rates. Although both techniques have gained broad acceptance in many countries, one major disadvantage of these techniques is the requirement for use of tumescent anesthesia to avoid the thermal injury of the surrounding structures. Cyanoacrylate closure for varicose veins has recently been introduced for treatment of the incompetent saphenous vein.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years of age at the time of enrollment
* Reflux in great saphenous vein greater than 0.5 seconds after distal compression and release or Valsalva's maneuver in the standing or reverse Trendelenburg position
* Diameter of saphenous vein between 2mm to 20mm (with standing position)
* One or more of the following symptoms related to the incompetent saphenous vein: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling
* Clinical, Etiologic, Anatomic, and Pathophysiologic classification of C2 through C5

Exclusion Criteria:

* Previous treatment in targeted vein segment
* Tortuous vein in which the delivery catheter cannot be inserted
* Aneurysm of target vein segment \>20 mm
* Daily use of narcotic or nonsteroidal anti-inflammatory pain medications to control pain associated with greater saphenous vein reflux
* Known hypercoagulable disorder
* Active malignancy
* Regular use of systemic anticoagulation
* Current use of systemic anticoagulant
* Previous deep vein thrombosis/pulmonary embolism or active acute superficial thrombophlebitis
* Unable to comply with the schedule and protocol evaluations
* Unable to ambulate
* Currently pregnant or breast feeding
* Known sensitivity to cyanoacrylate adhesives
* Symptomatic peripheral arterial disease with ankle-brachial index \<0.9
* Participation in another clinical study that has not reached primary endpoint within 30 days prior to enrollment
* Any condition which in the opinion of the investigator could compromise subject safety or adherence to the protocol

Primary outcomes:
measure: Closure rate of the target vein/ Absence of refluxing vein
timeFrame: 3 months
Secondary outcomes:
measure: Perioperative pain with visual analog scale
timeFrame: 3 days
measure: Ecchymosis
timeFrame: 3 days
measure: Venous Clinical Severity Score
timeFrame: 1, 3, 6, 12 and 24 months after treatment
measure: Acceptability of Quality of life score
timeFrame: 1, 3, 6, 12 and 24 months after treatment
measure: Satisfaction of the patients: satisfaction rate
timeFrame: 1, 3, 6, 12 and 24 months after treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: In-Mok Jung
state: Non US/Canada
city: Seoul
country: Korea, Republic of
facility: Jin Hyun Joh
state: Non US/Canada
Study officials:
affiliation: Kyung Hee University Hospital at Gangdong, Seoul, Korea
name: Jin Hyun Joh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaplan RM, Criqui MH, Denenberg JO, Bergan J, Fronek A. Quality of life in patients with chronic venous disease: San Diego population study. J Vasc Surg. 2003 May;37(5):1047-53. doi: 10.1067/mva.2003.168.
citation: van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg. 2009 Jan;49(1):230-9. doi: 10.1016/j.jvs.2008.06.030. Epub 2008 Aug 9.
citation: Morrison N, Gibson K, McEnroe S, Goldman M, King T, Weiss R, Cher D, Jones A. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. 2015 Apr;61(4):985-94. doi: 10.1016/j.jvs.2014.11.071. Epub 2015 Jan 31.
citation: Kolluri R, Gibson K, Cher D, Madsen M, Weiss R, Morrison N. Roll-in phase analysis of clinical study of cyanoacrylate closure for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2016 Oct;4(4):407-15. doi: 10.1016/j.jvsv.2016.06.017. Epub 2016 Aug 8.
citation: Chan YC, Law Y, Cheung GC, Ting AC, Cheng SW. Cyanoacrylate glue used to treat great saphenous reflux: Measures of outcome. Phlebology. 2017 Mar;32(2):99-106. doi: 10.1177/0268355516638200. Epub 2016 Jul 9.