Prospective trial to verify the efficacy and safety of sclerotherapy with polidocanol for painful venous malformations

JRCT ID: jRCTs061200036

Registered date:11/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Painful venous malformations
• Date of first enrollment: 16/12/2021
• Target sample size: 13
• Study type: Interventional
• Intervention(s): Sclerotherapy with polidocanol

Outcome(s)

• Primary Outcome: Change in NRS before treatment and NRS 3 months after treatment

Secondary Outcome

1) Volume reduction rate (%) 3 months after treatment compared to before treatment on MRI
2) Serious disease incidence (%) up to 1 month after treatment
3) Serious disease incidence (%) up to 3 months after treatment
4) Serious disease incidence (%) up to 6 months after treatment
5) Incidence rate of procedure-related diseases (%) up to 1 month after treatment
6) Pain improvement rate before and after treatment (%)
7) Change in NRS before treatment and NRS 6 months after treatment
8) Change in VAS (Visual Analogue Scale) before treatment and VAS 3 months after treatment
9) Change in VAS before treatment and VAS 6 months after treatment
10) Percentage change in pain frequency before and after treatment
11) Percentage change in medication before and after treatment
12) QOL (Quality Of Life) before treatment and QOL score change 3 months after treatment
13) QOL before treatment and QOL score change 6 months after treatment
*Using SF-36v2 (Short-Form Health Survey)

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Painful venous malformations.
2) The age is 12 years or older.
3) Diagnosis of VM by image examination before participating in this study.
4) There is a puncture cavity visible on CT or US.
5) It is possible to determine the preoperative and postoperative effects of the target lesion by simple MRI.
6) Performance Status (PS) is 0 to 2.
7) Written consent has been obtained from the patient or from the patient's legal representative if the patient is under 20 years old.

Exclude criteria

1) An important organ or vessel is present in the percutaneous puncture route.
2) Systemic active infection.
3) There is a possibility that she is pregnant or pregnant by interview.
4) Facial and head lesions.
5) Serum creatinine (Cr) level at screening exceeds 2.0 mg/dl.
6) Platelet count at screening is less than 50,000/microL.
7) PT-INR at screening is 1.5 or more.
8) Within 3 months after receiving pretreatment (surgery, irradiation, percutaneous sclerotherapy, etc.) for the target lesion.
*Excluding internal medicines such as Chinese herbs and analgesics that have been taken before registration. 9) History of deep vein thrombosis.
10) Comorbidity of arterial blood circulation disorders (including arteriosclerosis or diabetic microangiopathy)
11) The general condition is unstable.
12) Comorbidity of serious heart disease.
13) Comorbidity of active bronchial asthma.
14) History of hypersensitivity to contrast media or polidocanol components.
15) There is active inflammation or ulcer in and around the treatment site.
16) History of stroke due to paradoxical embolism mediated patent foramen ovale.
17) In addition, the doctor determines that the subject is inappropriate for this study due to conflicts of interest.

Related Information

• Primary Sponsor: Uka Mayu