Cyanoacrylate Closure Versus Surgical Stripping for Incompetent Saphenous Veins

NCT ID: NCT03835559

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-10
• Study Completion Date: 2021-02-01

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.

Conditions

Occlusions Vein; Chronic Venous Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cyanoacrylate closure

After successful access of target vein and insertion of guidewire under any type of anesthesia, the procedure of cyanoacrylate closure for treatment of incompetent Saphenous Veins is performed. A 5 French introducer and catheter is advanced and positioned 5.0 cm caudal to the junction with proximal saphenous vein compression by the ultrasound probe, two injections of approximately 0.10 mL glue are given 1 cm apart, followed by a 3min period of compression, and then repeat injections and 30sec ultrasound probe and hand compression sequences until the entire length of the target vein is treated. The catheter is removed.

Group Type: ACTIVE_COMPARATOR

Cyanoacrylate closure

Intervention Type: PROCEDURE

After successful access of target vein and insertion of guidewire under any type of anesthesia, the procedure of cyanoacrylate closure is performed. A 5 French introducer and catheter is advanced and positioned 5.0 cm caudal to the junction with proximal saphenous vein compression by the ultrasound probe, two injections of approximately 0.10 mL glue are given 1 cm apart, followed by a 3min period of compression, and then repeat injections and 30sec ultrasound probe and hand compression sequences until the entire length of the target vein is treated. The catheter is removed.

Surgical stripping

Intervention Type: PROCEDURE

All types of anesthesia (general, spinal, regional block, or local anesthesia) can be used. The surgical stripping is performed with a proper incision in the groin, with division and ligation of the saphenous vein and division of all tributaries. The saphenous vein is then removed using a stripper.

Surgical stripping

For treatment of incompetent Saphenous Veins, surgical stripping is performed with a proper incision in the groin, with division and ligation of the saphenous vein and division of all tributaries under all types of anesthesia (general, spinal, regional block, or local anesthesia). The saphenous vein is then removed using a stripper. Compression stocking is apply.

Group Type: ACTIVE_COMPARATOR

Cyanoacrylate closure

Intervention Type: PROCEDURE

After successful access of target vein and insertion of guidewire under any type of anesthesia, the procedure of cyanoacrylate closure is performed. A 5 French introducer and catheter is advanced and positioned 5.0 cm caudal to the junction with proximal saphenous vein compression by the ultrasound probe, two injections of approximately 0.10 mL glue are given 1 cm apart, followed by a 3min period of compression, and then repeat injections and 30sec ultrasound probe and hand compression sequences until the entire length of the target vein is treated. The catheter is removed.

Surgical stripping

Intervention Type: PROCEDURE

All types of anesthesia (general, spinal, regional block, or local anesthesia) can be used. The surgical stripping is performed with a proper incision in the groin, with division and ligation of the saphenous vein and division of all tributaries. The saphenous vein is then removed using a stripper.

Interventions

Cyanoacrylate closure

After successful access of target vein and insertion of guidewire under any type of anesthesia, the procedure of cyanoacrylate closure is performed. A 5 French introducer and catheter is advanced and positioned 5.0 cm caudal to the junction with proximal saphenous vein compression by the ultrasound probe, two injections of approximately 0.10 mL glue are given 1 cm apart, followed by a 3min period of compression, and then repeat injections and 30sec ultrasound probe and hand compression sequences until the entire length of the target vein is treated. The catheter is removed.

Intervention Type: PROCEDURE

Surgical stripping

All types of anesthesia (general, spinal, regional block, or local anesthesia) can be used. The surgical stripping is performed with a proper incision in the groin, with division and ligation of the saphenous vein and division of all tributaries. The saphenous vein is then removed using a stripper.

Intervention Type: PROCEDURE

Other Intervention Names

Cyanoacrylate closure for incompetent Saphenous vein; Surgical stripping for 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kyung Hee University Hospital at Gangdong

OTHER

Sponsor Role: lead

Responsible Party

Jin Hyun Joh

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jin Hyun Joh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kyung Hee University Hospital at Gangdong, Seoul, Korea

Locations

In-Mok Jung

Seoul, Non US/Canada, South Korea

Site Status: RECRUITING

Jin Hyun Joh

Seoul, Non US/Canada, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jin Hyun Joh, MD, PhD

Role: CONTACT

vascularjoh@gmail.com

+82-2-440-6261

Facility Contacts

Jin H Joh

Role: primary

vascularjoh@gmail.com

Jin H Joh

Role: primary

vascularjoh@gmail.com

References

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.

Reference Type: RESULT

PMID: 12756353 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18692348 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25650040 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27638993 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27052039 (View on PubMed)

Other Identifiers

2018-03-030-001

Identifier Type: -

Identifier Source: org_study_id