Evaluation of the safety and feasibility of foam injection combined with laser treatment for varicose veins
| ISRCTN | ISRCTN17095383 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17095383 |
| Secondary identifying numbers | 21-33 |
- Submission date
- 21/02/2022
- Registration date
- 09/03/2022
- Last edited
- 26/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Chronic venous disease (CVD) occurs when the wall and/or valves in the leg veins do not work effectively, making it difficult for blood to return to the heart from the legs. CVD is a common cause of leg pain and swelling and is commonly associated with varicose veins (swollen and enlarged veins). Although CVD is frequently associated with the great saphenous vein, the small saphenous vein (SSV) is responsible for about 15% of varicose vein cases. Foam sclerotherapy involves injecting foam into a vein to close it. Endovenous laser ablation uses heat from a laser to reduce varicose veins. This study aims to determine if adding foam sclerotherapy to endovenous laser ablation can improve the venous clinical severity score and reduce the need for secondary treatment and reduce recurrence.
Who can participate?
Patients aged 18 to 86 years with varicose veins of the SSV
What does the study involve?
Participants are randomly allocated to one of two groups. Half of the participants will receive foam sclerotherapy combined with endovenous laser ablation. The other half will receive endovenous laser ablation alone. All participants will be evaluated 1 year later for recurrence and the need for additional follow-up interventions.
What are the possible benefits and risks of participating?
The patients may benefit from an effective treatment of their varicose veins that is less invasive. The study does not involve any major risks as the treatment is very well known.
Where is the study run from?
Sakurabashi Watanabe Hospital (Japan)
When is the study starting and how long is it expected to run for?
September 2016 to September 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Satoshi Watanabe
sa_watanabe@watanabe-hsp.or.jp
Contact information
Principal Investigator
Umeda 2-4-32, Kita-ku
Osaka
530-0001
Japan
 ORCID ID |
0000-0003-3917-0894 |
|---|---|
| Phone | +81 (0)6 6341 8651 |
| sa_watanabe@watanabe-hsp.or.jp |
Study information
| Study design | Single-centre interventional double-blinded randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | In adult patients with small saphenous vein incompetence, how effective is transluminal injection of foam sclerotherapy added to endovenous laser ablation compared to endovenous laser ablation alone in controlling post-procedure outcome during 1-year follow-up time? |
| Study objectives | To compare concurrent foam sclerotherapy through the access sheath (transluminal injection of foam sclerotherapy [TLFS]) combined with endovenous laser ablation (EVLA) with EVLA alone in terms of safety, need for secondary interventions, and 1-year venous clinical severity score (VCSS) changes in patients with chronic venous insufficiency and small saphenous vein (SSV) incompetence. |
| Ethics approval(s) |
Approved 16/04/2016, Sakurabashi Watanabe Hospital Medical Ethics Committee (Umeda 2-4-32, Kita-ku, Osaka, 530-0001, Japan; +81 (0)6 6341 8660; i_oka@watanabe-hsp.or.jp), ref: 21-33 |
| Health condition(s) or problem(s) studied | Varicose veins |
| Intervention | Current interventions as of 30/09/2022: Patients with symptomatic primary SSV reflux are randomised by sealed envelopes to either TLFS with EVLA or EVLA alone. Secondary intervention using the same foam concentration is performed if reflux of the targeted tributary is detected on Doppler ultrasound or if the varicosities remained clinically visible. Post-procedure evaluations are performed to assess vein occlusion, sclerotherapy-related deep vein thrombosis, and endovenous heat-induced thrombosis at 1 day, 1 week, 1 month, and 12 months. Outcomes assessed at 1 year include the presence of residual or recurrent reflux, clinical recurrence, sensory complications, the need for secondary interventions, and venous clinical severity score (VCSS) changes. All adverse events that occurred during or <30 days after procedures were considered to be procedure-related. The American Venous Forum/Society of Interventional Radiography classification system grades complications as minor or major. The outcome assessments were performed by an attending physician who was unaware of the actual intervention. _____ Previous interventions: Patients with symptomatic primary SSV reflux are randomised by flipping a coin to either TLFS with EVLA or EVLA alone. Secondary intervention using the same foam concentration is performed if reflux of the targeted tributary is detected on Doppler ultrasound or if the varicosities remained clinically visible. Post-procedure evaluations are performed to assess vein occlusion, sclerotherapy-related deep vein thrombosis, and endovenous heat-induced thrombosis at 1 day, 1 week, 1 month, and 12 months. Outcomes assessed at 1 year include the presence of residual or recurrent reflux, clinical recurrence, sensory complications, the need for secondary interventions, and venous clinical severity score (VCSS) changes. All adverse events that occurred during or <30 days after procedures were considered to be procedure-related. The American Venous Forum/Society of Interventional Radiography classification system grades complications as minor or major. The outcome assessments were performed by an attending physician who was unaware of the actual intervention. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Current primary outcome measure as of 26/07/2023: Venous clinical severity score (VCSS) improvement at 1 day, 1 week, 1 month, and 1 year _____ Previous primary outcome measure: The presence of residual or recurrent reflux measured using colour Doppler ultrasound at 1 day, 1 week, 1 month, and 1 year |
| Secondary outcome measures | Current secondary outcome measures as of 26/07/2023: All reported ipsilateral superficial venous re-interventions due to the symptomatic residual or recurrent reflux of truncal SSVs and/or tributary veins or patient complaints of visible varicosities with cosmetic concerns or any reported procedural complications. These included sensory complications, endovenous heat-induced thrombosis (EHIT), superficial thrombophlebitis, sclerotherapy-related DVT / pulmonary embolism, and allergic or anaphylactic reactions. _____ Previous secondary outcome measures: 1. Sclerotherapy-related deep vein thrombosis (DVT) measured using colour Doppler ultrasound at 1 day, 1 week, 1 month, and 1 year 2. Endovenous heat-induced thrombosis (EHIT) measured using colour Doppler ultrasound at 1 day, 1 week, 1 month, and 1 year 3. Sensory complications measured by asking participants about their recovery status and complications at 1 day, 1 week, 1 month, and 1 year 4. The need for secondary interventions measured using colour Doppler ultrasound at 1 day, 1 week, 1 month, and 1 year 5. Clinical outcome measured using the venous clinical severity score (VCSS) at 1 day, 1 week, 1 month, and 1 year |
| Overall study start date | 08/09/2016 |
| Completion date | 02/09/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 191 patients (214 legs) |
| Total final enrolment | 134 |
| Key inclusion criteria | Patients with unilateral or bilateral varicose veins of the SSV with clinical class C2 to C6 disease using the clinical, etiologic, anatomic, and pathophysiologic (CEAP) classification |
| Key exclusion criteria | 1. Recurrent varicose veins after previous surgery, EVLA, or foam sclerotherapy 2. A hypersensitivity reaction to sclerotherapy 3. Acute deep vein thrombosis (DVT) or a history of DVT 4. Severe lower limb ischaemic disease (lower extremity arteriosclerosis obliterans, thromboangiitis obliterans, acute arterial embolism, or Raynaud syndrome) 5. Coagulation disorder 6. Indications for simultaneous EVLA in both the GSV and SSV |
| Date of first enrolment | 08/09/2016 |
| Date of final enrolment | 02/09/2020 |
Locations
Countries of recruitment
- Japan
Study participating centre
Osaka
530-0001
Japan
Sponsor information
Hospital/treatment centre
Umeda 2-4-32, Kita-ku
Osaka
530-0001
Japan
| Phone | +81 (0)6 6341 8653 |
|---|---|
| medicine@watanabe-hsp.or.jp | |
| Website | http://www.watanabe-hsp.or.jp/ |
"ROR" |
https://ror.org/03rx00z90 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated or analyzed during the current study during this study will be included in the publication of the subsequent results |
Editorial Notes
26/07/2023: The following changes were made to the trial record:
1. The ethics approval date was changed from 16/04/2021 to 16/04/2016.
2. The overall start date was changed from 01/09/2016 to 08/09/2016.
3. The overall end date was changed from 15/09/2020 to 02/09/2021.
4. The primary outcome measure was changed.
5. The secondary outcome measures were changed.
6. The plain English summary was updated to reflect these changes.
7. The intention to publish date was changed from 01/09/2022 to 01/11/2023.
30/09/2022: The interventions were changed.
15/06/2022: The following changes were made to the trial record:
1. The overall trial end date was changed from 15/09/2021 to 15/09/2020.
2. The intention to publish date was changed from 01/06/2022 to 01/09/2022.
07/03/2022: Trial's existence confirmed by the Sakurabashi Watanabe Hospital Medical Ethics Committee.
