Dataset Information

Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA): study protocol for a randomized controlled trial.

ABSTRACT: Radiofrequency ablation (RFA) is associated with an excellent outcome in the treatment of great saphenous vein (GSV) incompetence. The use of thermal energy as a treatment source requires the instillation of tumescence anesthesia. Mechanochemical endovenous ablation (MOCA) combines mechanical endothelial damage, using a rotating wire, with the infusion of a liquid sclerosant. Tumescence anesthesia is not required. Preliminary experiences with MOCA showed good results and low post-procedural pain.The MARADONA (Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation) trial is a multicenter randomized controlled trial in which 460 patients will be randomly allocated to MOCA or RFA. All patients with primary GSV incompetence who meet the eligibility criteria will be invited to participate in this trial. The primary endpoints are anatomic and clinical success at a one-year follow-up, and post-procedural pain. The secondary endpoints are technical success, complications, operation time, procedural pain, disease-specific quality of life, time taken to return to daily activities and/or work, and cost-efficiency analyses after RFA or MOCA. Both groups will be evaluated on an intention to treat base.The MARADONA trial is designed to show equal results in anatomic and clinical success after one year, comparing MOCA with RFA. In our hypothesis MOCA has an equal anatomic and clinical success compared with RFA, with less post-procedural pain.Clinicaltrials NCT01936168.

SUBMITTER: van Eekeren RR

PROVIDER: S-EPMC3996515 | biostudies-literature | 2014 Apr

REPOSITORIES: biostudies-literature

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Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA): study protocol for a randomized controlled trial.

van Eekeren Ramon R J P RR Boersma Doeke D Holewijn Suzanne S Vahl Anco A de Vries Jean Paul p m JP Zeebregts Clark J CJ Reijnen Michel M P J MM

Trials 20140411

<h4>Background</h4>Radiofrequency ablation (RFA) is associated with an excellent outcome in the treatment of great saphenous vein (GSV) incompetence. The use of thermal energy as a treatment source requires the instillation of tumescence anesthesia. Mechanochemical endovenous ablation (MOCA) combines mechanical endothelial damage, using a rotating wire, with the infusion of a liquid sclerosant. Tumescence anesthesia is not required. Preliminary experiences with MOCA showed good results and low p ...[more]

PMID: 24726004

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Project description:INTRODUCTION:Endovenous ablations are the new standard procedures for treatment of great saphenous vein reflux including endovenous laser ablation (EVLA), radio frequency ablation (RFA), endovenous steam ablation (EVSA), mechanochemical ablation (MOCA), cyanoacrylate injection and ultrasound-guided foam sclerotherapy (UGFS). EVLA and RFA have demonstrated similar anatomical success for short-term outcome, but results are controversial for longer term (?5 years). Additional evidences from randomised controlled trials have been published. This study is, therefore, conducted to, directly and indirectly, compare outcomes among all procedures stratifying by short-term and long-term follow-up. METHODS AND ANALYSIS:Medline and Scopus will be searched from 2000 to September 2018 with predefined search strategy. Interventions of interest are open surgery (ie, saphenofemoral or high ligation (HL) with stripping) and endovenous ablations (ie, EVLA, RFA, EVSA, MOCA, cyanoacrylate injection and UGFS). The primary outcome is anatomical success. Two independent reviewers will select studies, extract data and assess risk of bias. Disagreement will be adjudicated by the third party. Outcomes will be directly pooled if there are at least three studies in that comparison. A fixed-effect model will be used unless heterogeneity is present, in which case a random-effect model will be applied. Sources of heterogeneity will be explored using meta-regression analysis, and sub-group analysis will be done accordingly. Publication bias will be assessed using Egger's test and funnel plot. A network meta-analysis will be applied to indirect compare all interventions including RFA, EVLA, EVLA with HL, UGFS, UGFS with HL and HL with stripping. Probability of being best intervention will be estimated and ranked. Inconsistency assumption will be checked using a design-by-treatment interaction model. ETHICS AND DISSEMINATION:Ethical approval is not required for systematic review and network meta-analysis. The study will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER:CRD42018096794.

Project description:ImportanceEndovenous thermal ablations (ETAs) are recommended as first-line treatment for truncal vein reflux, have a short recovery time, and are cost-effective. However, ETAs are associated with discomfort during tumescent anesthesia infiltration. To minimize discomfort, nonthermal, nontumescent ablation techniques had emerged in the form of mechanochemical ablation (MOCA) and cyanoacrylate adhesive injection (CAE).ObjectiveTo assess pain scores immediately after truncal ablation using a 100-mm visual analog scale and 10-point number scale to compare pain-related outcomes following mechanochemical ablation vs cyanoacrylate adhesive treatment.Design, setting, and participantsThe Multicenter Randomized II Clinical Trial Comparing Mechanochemical Ablation vs Cyanoacrylate Adhesive for the Treatment of Primary Truncal Saphenous Veins Incompetence study was a prospective multicenter randomized clinical trial conducted at 3 sites between November 2017 and January 2020. Inclusion criteria were primary great or small saphenous varicose veins; exclusion criteria included recurrent varicose veins, current deep venous thrombosis, or serious arterial disease. There were 392 participants screened, 225 were excluded, and 167 participants underwent randomization. Four participants did not receive allocated intervention and were included in the intention-to-treat analysis. Follow-up took place at 2 weeks, and 3, 6, and 12 months.InterventionsPatients with primary truncal vein incompetence were randomized to receive either MOCA or CAE.Main outcomes and measuresThe primary outcome measure was pain score immediately after completing truncal ablation using a 100-mm visual analog scale (VAS) and a 10-point number scale. Secondary outcome measures included degree of ecchymosis, occlusion rates, clinical severity, and generic and disease-specific quality of life (QoL) scores.ResultsOf 167 study participants, 99 (59.3%) were women, and the mean (SD) age was 56 (15.8) years. Overall, 155 truncal veins treated (92.8%) were great saphenous veins. Demographic data and baseline status were comparable between treatment groups. A total of 73 patients (47%) underwent adjunctive treatment of varicosities. Overall median (IQR) maximum pain score after truncal treatment was 23 mm (10-44) on the VAS and 3 (2-5) on the number scale, showing no significant difference in median (IQR) pain measured by VAS (MOCA, 24 [11.5-44.7] mm vs CAE, 20 [9.0-42.0] mm; P = .23) or by number scale (MOCA, 4 [2-5] vs CAE, 3 [2-4]; P = .18). Both groups demonstrated significant and comparable improvement in clinical severity, generic and disease-specific QoL scores, and complete occlusion rates. Four patients treated with CAE developed minor complications (superficial thrombophlebitis and thrombus extensions).Conclusions and relevanceTo our knowledge, this was the first randomized clinical trial directly comparing nontumescent ablation techniques. The study demonstrated that the MOCA and CAE techniques have a similar periprocedural pain score.Trial registrationClinicalTrials.gov Identifier: NCT03392753.

Project description:BackgroundRecurrent varicosities after endovascular laser ablation (EVLA) of the great saphenous vein (GSV) are frequently due to varicose transformed, initially unsealed major ascending tributaries of the saphenofemoral junction (SFJ). Preventive ablation of these veins, especially the anterior accessory saphenous vein, is discussed as an option, along with flush occlusion of the GSV. However, few related data exist to date.MethodsA consecutive case series of 278 EVLA procedures of the GSV for primary varicosis in 213 patients between May and December 2019 was retrospectively reviewed. The ablations were performed with a 1470 nm dual-ring radial laser and always included flush occlusion of the GSV, and concomitant ablation of its highest ascending tributaries by additional cannulation and ablation when this seemed anatomically appropriate. The initial technical success, comprising occlusion of the GSV and its major tributaries, was set as the primary endpoint. Possible determinants were explored using downstream multiple logistic regression analysis.ResultsThe early technical success was 92.8%, with the GSV occluded in 99.6% and the highest ascending SFJ tributary, if present, in 92.4%. Additional ablations of ascending tributaries were performed in 171 cases (61.5%), the latter being associated with success (OR 10.39; 95% CI [3.420-36.15]; p < 0.0001). Presence of anterior as opposed to posterior accessory saphenous vein was another positive predictor (OR 3.959; 95% CI [1.142-13,73]; p = 0.027), while a confluence of the tributary in the immediate proximity to the SFJ had a negative impact (OR 0.2253; 95% CI [0.05456-0.7681]; p = 0.0253). An endothermal heat-induced thrombosis (EHIT) ≥ grade 2 was observed in three cases (1.1%).ConclusionsA co-treatment of the tributaries is feasible and could improve the technical success of EVLA if a prophylactic closure of these veins is desired, especially if their distance to the SFJ is short. Its effect on the recurrence rate needs further research.

Project description:BackgroundEndovenous thermal techniques, such as endovenous laser ablation (EVLA), are the recommended treatment for truncal varicose veins. However, a disadvantage of thermal techniques is that it requires the administration of tumescent anaesthesia, which can be uncomfortable. Non-thermal, non-tumescent techniques, such as mechanochemical ablation (MOCA) have potential benefits. MOCA combines physical damage to endothelium using a rotating wire, with the infusion of a liquid sclerosant. Preliminary experiences with MOCA showed good results and less post-procedural pain.Methods/designThe Laser Ablation versus Mechanochemical Ablation (LAMA) trial is a single-centre randomised controlled trial in which 140 patients will be randomly allocated to EVLA or MOCA. All patients with primary truncal superficial venous insufficiency (SVI) who meet the eligibility criteria will be invited to participate in this trial. The primary outcomes are intra-procedural pain and technical efficacy at 1 year, defined as complete occlusion of target vein segment and assessed using duplex ultrasound. Secondary outcomes are post-procedural pain, analgesia use, procedure time, clinical severity, generic and disease-specific quality of life, bruising, complications, satisfaction, cosmesis, time taken to return to daily activities and/or work, and cost-effectiveness analysis following EVLA or MOCA. Both groups will be evaluated on an intention-to-treat basis.DiscussionThe aim of the LAMA trial is to establish whether MOCA is superior to the current first-line treatment, EVLA. The two main hypotheses are that MOCA may cause less initial pain and disability allowing a more acceptable treatment with an enhanced recovery. The second hypothesis is that this may come at a cost of decreased efficacy, which may lead to increased recurrence and affect longer term quality of life, increasing the requirement for secondary procedures.Trial registrationClinicalTrials.gov identifier: NCT02627846 , registered 8 December 2015 EudraCT number: 2015-000730-30 REC ref: 15/YH/0207 R&D ref: R1788.

Dataset Information

Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA): study protocol for a randomized controlled trial.

Publications

Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA): study protocol for a randomized controlled trial.

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