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

Not Applicable

Recruiting

• Conditions: Painful venous malformations

• Registration Number: JPRN-jRCTs061200036
• Lead Sponsor: ka Mayu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-11
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 13

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified