A study for evaluation of efficacy and safety of ethanolamine oleate in patients with venous malformations

JRCT ID: jRCT2051200046

Registered date:25/08/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Venous malformation difficult to remove
• Date of first enrollment: 15/01/2021
• Target sample size: 44
• Study type: Interventional
• Intervention(s): Injection of 5% ethanolamine oleate which is double diluted by contrast or normal saline for the venous malformation, within maximum dosage of 0.4 mL/kg. Same method of administration is performed for children (under 15 yers old). Maximum volume of the drug in once treatment is 30 mL after preparation.

Outcome(s)

• Primary Outcome: 20% or more reduction in volume of venous malformations at the time of 3 months after intervention

Secondary Outcome

(Significant secondary endpoint)
Improvement in symptoms such as pain originated from venous malformations at the time of 3 months after intervention

(Other secondary endpoints)
1) Reduction rate in volume of venous malformations at the time of 3 months after intervention
2) Improvement in symptoms such as pain originated from venous malformations at the time of 1 months (4 weeks) after intervention
3) Improvement of QOL (ADL) at the time of 3 months after intervention

(Other endpoint)
Rate of change in apprearance at the time of 3 months after intervention; much improvement, improvement, no change and worse.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. No age limitation
2. Signed informed consent from patient or legal guardian(s) (In case age of patient is under 20 years old)
3. Venous malformations are considered difficult to remove, and sclerotherapy is considered first line treatment option by investigator/sub-investigator. Difficulty to remove means a high risk of functional dysfunction due to excision, or a loss of appearance to affect in daily life.
4. Patients who have one or more target venous malformations with a major axis of 30 mm or more in extremities, and 20 mm or more in head and neck region on MRI or CT
5. No thrombus and organized tissue that affects image evaluation or effect judgment in target venous malformations

Exclude criteria

1. Patients with multiple organ failure or DIC (Disseminated intravascular coagulation)
2. Patients who are taking or have taken drugs that may affect resolution of lesions (propranolol, herbal medicines [such as Kamishoyosan, Ninjinyoeito, Eppikajutsuto or Ogikenchuto], or sirolimus). However, patients can participate in the clinical study in case herbal medicines are discontinued 2 weeks or more before study drug administration.
3. Patients with diabetes mellitus with HbA1c>=8.0, or autoimmune disorder
4. Patients with liver dysfunction judged as grade C (10-15 points) in Child-Pugh classification
5. Patients with renal dysfunction with eGFR < 60mL/min/1.73m2
6. Patients with cardiac dysfunction with over grade II in NYHA classification
7. Patients having sclerotherapy within 6 months before obtaining informed consent
8. Patients with history of allergy to ethanolamine oleate or angiographic X-ray contrast agent as concomitant drugs
9. Patients having surgery over 45 minutes within 2 weeks before obtaining informed consent
10. Patients participating in other clinical study within 4 weeks before obtaining informed consent
11. Pregnant women, women who may be pregnant, or lactating women
12. Patients who are judged as inappropriate by investigator/sub-investigator

Related Information

• Primary Sponsor: Nomura Tadashi
• Secondary Sponsor: Nomura Tadashi,Ozaki Mine