Clinical trial NCT02627846: Laser Ablation Versus Mechanochemical Ablation Trial
Official title: A Randomised Clinical Trial Comparing Endovenous Laser Ablation and Mechanochemical Ablation (ClariVein®) in the Management of Superficial Venous Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Varicose Veins
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2015-12-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomised clinical trial comparing endovenous laser ablation and mechanochemical ablation (ClariVein®) in the management of superficial venous insufficiency.

Detailed description: Varicose veins, a very common problem in UK, may cause symptoms including pain, heaviness and itching in the lower legs. Overtime, bleeding and damage to surround soft tissues may develop, leading to venous ulcer which can be very painful, debilitating, difficult to heal and very expensive to treat.

Newer minimally invasive techniques are preformed using local anaesthetic. The recovery has been shown to be more rapid, due to less pain and disability when compared to open surgery. These techniques use either heat or a chemical/medicine injected inside the varicose veins to close them permanently. In 2013 National Institute of Health and Care Excellence (NICE) recommended that methods using heat such as endovenous laser ablation (EVLA) should be first choice as the chemical methods have been shown to have a significantly lower treatment success rates in closing varicose veins permanently. Chemical methods however do have their advantages, as they require far fewer injections of local anaesthetic than the heat methods and these injections can be a source of significant discomfort.

Since NICE guidelines, a new treatment technique known as mechanochemical ablation (MOCA) using ClariVein® has been developed. This device injects a chemical into the vein through a rotating hollow wire, which causes the vein to narrow and damages the lining of the vein, making the chemical more effective. This new treatment technique aims to match the success rates of the heat method, but with less pain since it avoids most of the local anaesthetic injections. Both treatments are currently used in the UK, however there is insufficient evidence as to whether one is better, or the same.

This trial will randomly allocate volunteer patients to have their varicose veins treated with either EVLA or MOCA. The investigators will assess a range of outcomes including pain scores, success rates, complications, quality-of-life and costs to see which, if any, of these treatments offer better results. Long term follow-ups will occur at 5 and 10 years.

Eligibility criteria: Inclusion Criteria:

* Aged 18 or over
* Symptomatic SVI which will likely benefit from treatment in the opinion of an experienced specialist and the participant
* Clinical grades C2-C6 on the CEAP system
* Superficial axial incompetence with proposed treatment lengths of at least 10cm
* Treatment with either endovenous laser ablation or mechanochemical ablation is technically feasible in the view of an experienced endovenous specialist
* Patient is willing to participate (including acceptance of randomisation to either treatment) and give valid, informed consent in the English language

Exclusion Criteria:

* One of the treatments is thought to be preferable by either the patient or an experienced endovenous specialist
* Unwilling or inability to comply with the requirements for follow-up visits
* Known allergy to medications or dressings used in the treatment
* Known right to left circulatory shunt
* Evidence of acute deep venous thrombosis or complete ipsilateral occlusion
* Pelvic vein insufficiency
* Active or recent thrombophlebitis (within 6 weeks)
* Impalpable foot pulses with an Ankle-Brachial Pressure Index of less than 0.8
* Pregnancy or breast feeding
* Active malignancy
* Immobility
* Involvement in other CTIMP trials within the last 6 months

Primary outcomes:
measure: Intra-procedural Pain
timeFrame: Up to end of intervention
measure: Technical Efficacy assessed by successful procedure defined as complete occlusion of the target vein segment.
timeFrame: At 1 year
Secondary outcomes:
measure: Aberdeen Varicose Vein Questionnaire (AVVQ)
timeFrame: 1 week, 6 weeks, 6 months, 1 year
measure: Chronic Venous disease quality of life Questionnaire (CIVIQ-20)
timeFrame: 1 week, 6 weeks, 6 months, 1 year
measure: VEnous INsufficiency Epidemiological and Economic Study to evaluate Quality of Life and Symptoms (VEINES-QOL/Sym)
timeFrame: 1 week, 6 weeks, 6 months, 1 year
measure: Short Form 36
timeFrame: 1 week, 6 weeks, 6 months, 1 year
measure: EuroQol (EQ5D)
timeFrame: 1 week, 6 weeks, 6 months, 1 year
measure: Post-procedural Pain
timeFrame: Throughout the first week after the procedure
measure: Analgesia Use
timeFrame: 1 week
measure: Bruising visual analogue scale
timeFrame: 1 week, 6 weeks, 6 months, 1 year
measure: Satisfactory visual analogue scale
timeFrame: 1 week, 6 weeks, 6 months, 1 year
measure: Cosmesis visual analogue scale
timeFrame: 1 week, 6 weeks, 6 months, 1 year
measure: Recovery time
timeFrame: 1 week, 6 weeks, 6 months, 1 year
measure: Complications
timeFrame: 1 week, 6 weeks, 6 months, 1 year
measure: Recurrence of Varicose Veins
timeFrame: 1 week, 6 weeks, 6 months, 1 year
measure: Disease Progression
timeFrame: 1 week, 6 weeks, 6 months, 1 year
measure: Need for Further Treatment
timeFrame: 1 week, 6 weeks, 6 months, 1 year
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Hull and East Yorkshire Hospitals NHS Trust
Study officials:
affiliation: Hull University Teaching Hospitals NHS Trust
name: Ian Chetter, MBChB,MD,FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Hull University Teaching Hospitals NHS Trust
name: Abduraheem Mohamed, MBBS,BSc,MRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Hull University Teaching Hospitals NHS Trust
name: Daniel Carradice, MBBS,MRCS,DipHE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mohamed AH, Leung C, Wallace T, Smith G, Carradice D, Chetter I. A Randomized Controlled Trial of Endovenous Laser Ablation Versus Mechanochemical Ablation With ClariVein in the Management of Superficial Venous Incompetence (LAMA Trial). Ann Surg. 2021 Jun 1;273(6):e188-e195. doi: 10.1097/SLA.0000000000003749.
citation: Leung CC, Carradice D, Wallace T, Chetter IC. Endovenous laser ablation versus mechanochemical ablation with ClariVein((R)) in the management of superficial venous insufficiency (LAMA trial): study protocol for a randomised controlled trial. Trials. 2016 Aug 24;17(1):421. doi: 10.1186/s13063-016-1548-1.