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A single-arm clinical study of the efficacy and safety of sclerotherapy with polydocanol for venous malformations and macrocystic lymphatic malformations

Sclerotherapy with polydocanol for venous malformations and macrocystic lymphatic malformations

Mori Hiroki

Institute of Science Tokyo Hospital

1-5-45 Yushima Bunkyo-ku Tokyo

moriplas@tmd.ac.jp

Mori Hiroki

Institute of Science Tokyo Hospital

1-5-45 Yushima Bunkyo-ku Tokyo

+81-3-5803-5923

moriplas@tmd.ac.jp

Recruiting

Jan. 30, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) Patients with venous malformation or cystic lymphatic malformation lesions that are considered difficult to resect (resection may result in functional impairment or loss of cosmetic appearance that interferes with daily life) and for which sclerotherapy is considered the first choice of treatment
2) Patients with measurable lesions (venous malformation or cystic lymphatic malformation) measuring at least 20 mm in length on MRI or CT in the extremities or 10 mm in length in the head and neck
3) Patients for whom written consent has been obtained from the patient or a surrogate (if the patient is under 18 years of age at the time consent is obtained)
Patients with multiple lesions may be re-enrolled in the study and receive protocol treatment for another lesion after initial enrollment and completion of evaluation at 3 months postoperatively.

1) Patients with deep vein thrombosis or a history of thrombosis
2) Patients with arterial blood circulation problems (including those with atherosclerosis or diabetic microangiopathy)
3) Patients with difficulty walking
4) Patients with multiple organ damage or disseminated intravascular coagulation syndrome (DIC)
5) Patients taking oral contraceptives
6) Patients taking anticoagulants or antiplatelet agents
7) Patients with cardiac dysfunction of NYHA Classification II or higher
8) Patients in shock or pre-shock
9) Patients with a history of allergy to polidocanol or angiographic contrast media
10) Patients with bronchial asthma
11) Pregnant women, women who are pregnant or may become pregnant, and lactating women
12) Patients with inflammation or ulceration in and around the site of administration
13) Patients with or with a history of stroke or transient ischemic attack due to anomalous embolism via foramen ovale
14) Patients with hepatic dysfunction graded C (10-15 points)in the Child-Pugh classification
15)Patients with renal dysfunction with an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m2
16) Patients who are taking or have taken drugs that may affect the resolution of lesions (propranolol, Kampo [Kamishoyosan, Ginsen Yoeito, Ketsuyu Kashuyu, Hoki Kenchu-to], Sirolimus). (However, Chinese herbal medicines may be included if they were withdrawn at least 2 weeks prior to the start of administration of the investigational drug.
17) Patients who received sclerotherapy within 6 months prior to obtaining consent
18) Patients participating in other clinical trials or clinical studies within 4 weeks prior to obtaining consent
19) Patients who are deemed ineligible for participation in this study by the principal investigator (subinvestigator)

Both

Venous malformations and cystic lymphatic malformations

Sclerotherapy is performed on venous malformations or cystic lymphatic lesions with 3% polidocanol:air = 1:3 to 1:5 foam sclerosing agent.
The maximum dose per puncture is 2 to 6 mL of foam sclerosing agent, depending on the size of the lesion.
The total dose for one treatment should be no more than 2 mg/kg of polidocanol and 10 mL of foam sclerosing agent.
If treatment is not completed in a single treatment, multiple doses are allowed. As a rule, the next dose should be administered after one week.

venous malformation, cystic lymphatic malformation

Sclerotherapy, polidocanol, foam

Percentage of patients with target lesion volume reduction of at least 20% at 3 months after completion of sclerotherapy* compared to baseline (before treatment)

*The last day of sclerotherapy with the study drug. The same applies to secondary endpoints.

(1) Change from baseline (before treatment) in symptoms (pain) associated with the target lesion at 3 months after completion of sclerotherapy
(2) Change from baseline (pre-treatment) in quality of life (ADL) at 3 months after completion of sclerotherapy
(3) Percentage of change from baseline (Marked improvement, improvement, no change, or worsening) in appearance at 3 months after the end of sclerotherapy.

+81-3-5803-4574

Dec. 22, 2023

Non