Mechanochemical ablation versus cyanoacrylate adhesive for the treatment of varicose veins: study protocol for a randomised controlled trial

Abstract

BackgroundThermal ablation techniques have become the first-line treatment of truncal veins in the management of chronic venous disease (CVD). Despite excellent outcomes, these methods are often associated with pain; generally due to their use of heat and the necessity of fluid infiltration around the vein. More recently, novel non-thermal techniques, such as mechanochemical ablation (MOCA) and cyanoacrylate adhesive (CAE) have been developed to overcome these unwelcome effects. So far, the novel techniques have been found to have similar efficacy to thermal methods, yet no direct comparisons between the non-thermal treatment techniques have been conducted to date, giving rise to this study.Methods/designThis is a prospective, multicentre, randomised clinical trial, recruiting patients with truncal saphenous incompetence. Patients will be randomised to undergo either MOCA or CAE truncal ablation, followed by treatment of any varicosities. All patients will be required to wear compression stockings for 4 days post intervention. The primary outcome measure is the pain score immediately following completion of truncal ablation, measured by a 100-mm Visual Analogue Scale (VAS). The secondary outcomes are entire treatment pain scores, clinical scores, quality of life scores, occlusion rates, time to return to usual activities/work at 2 weeks, 3, 6 and 12 months. Re-intervention rate will be considered from the third month. Cost-effectiveness will be assessed for each intervention at 12 months. The study is powered to detect a mean 10-mm difference in maximum pain score. Allowing for loss to follow-up, the total target recruitment is 180 patients.DiscussionThe study will be the first study to compare MOCA against CAE and is designed to determine which method causes less pain. Completion of this study is expected to be the end of 2019.Trial registrationClinicalTrials.gov, ID: NCT03392753. Registered on 17 November 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2807-0) contains supplementary material, which is available to authorized users.

One-year outcome using cyanoacrylate glue to ablate truncal vein incompetence: A Singapore VenaSeal™ real-world post-market evaluation study (ASVS)

“…MOCCA (MechanOChemical ablation versus Cyanoacrylate Adhesive for the treatment of varicose veins; NCT03392753) is a prospective, multicentre, randomised clinical trial, recruiting patients with truncal saphenous incompetence. 34 Patients will be randomised to undergo either MOCA or CAG truncal ablation, followed by treatment of any varicosities. The primary outcome measure is the pain score immediately following completion of truncal ablation.…”

Cyanoacrylate glue using the VenaSeal™ Closure System for varicose veins may not be the panacea endovenous ablation device-more complications than you think

“…Many of the trials and early feasibility studies quote zero percent deep vein thrombosis (DVT) rate and this has been used as a unique selling point to attempt to gain market share, but this is misleading. From the beginning, Almeida's first in man study showed thread-like extension into the common femoral vein [8] and while no PE resulted from this, they have been reported in subsequent series [7,11,24,25]. Less common adverse events of any kind require particular vigilance, and the small numbers in early studies showing no DVT means insufficient power to detect rare but potentially devastating complications.…”

<p>ClariVein^®, mechanochemical endovenous ablation: patient selection and perspective</p>

“…11,18 Tumescent-less versus tumescent-less Interrogation of four international registries reveals only one trial aiming to compare an endovenous tumescentless method with another. This study, the MOCCA randomised controlled trial 25 (mechanochemical ablation versus cyanoacrylate adhesive in the treatment of truncal saphenous incompetence) was designed to compare the degree of pain that patients experience while receiving MOCA or CAE ablation. So far, the trial has recruited 120 patients of the target 180, and the final results of this trial are expected towards the end of 2020.…”