Sodium hyaluronate–stabilized poly(cinnamyl alcohol) foam versus ordinary foam for head and neck venous malformations

Efficacy and Safety Analysis of More Stable Foam and Ordinary Foam Based on Polylauricol in the Treatment of Head and Neck Venous Malformations: a Prospective, Randomized and Controlled Study

This trial will test whether a sodium hyaluronate–stabilized poly(cinnamyl alcohol) foam works better and is safer than ordinary foam for people aged 14–60 with head and neck venous malformations.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 14 Years to 60 Years
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (Academic / other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT07066527 on ClinicalTrials.gov

What this trial studies

This single-center, prospective randomized trial at Qilu Hospital compares a sodium hyaluronate–stabilized poly(cinnamyl alcohol) microfoam with standard foam sclerotherapy for venous malformations of the head and neck. Eligible patients aged 14–60 with imaging-confirmed head and neck venous malformations are randomized to receive injections of the stabilized foam or ordinary foam into lesion lacunae under image guidance. The stabilized foam is intended to displace blood, prolong sclerosant contact with the endothelium, and reduce dilution compared with liquid agents, and outcomes include lesion size reduction, symptom relief, and adverse events. Patients are followed at predefined intervals to compare efficacy, recurrence, and safety between the two foam preparations.

Who should consider this trial

Good fit: Ideal candidates are patients aged 14–60 with imaging-confirmed head and neck venous malformations who are medically fit, not pregnant, and able to provide informed consent and attend follow-up at Qilu Hospital.

Not a fit: Patients with uncontrolled serious systemic diseases, significant cardiac conduction or function problems, poorly controlled diabetes, pregnant women, or those with non-venous vascular lesions are unlikely to benefit or may be excluded.

Why it matters

Potential benefit: If successful, the stabilized foam could improve lesion control and reduce recurrence or complications compared with ordinary foam sclerotherapy.

How similar studies have performed: Foam sclerotherapy has been shown to be more effective than liquid sclerosants in prior work, but adding sodium hyaluronate to stabilize poly(cinnamyl alcohol) foam is a relatively novel modification with limited published clinical data.

Eligibility criteria

Inclusion Criteria:

1. Age 14-60 years of age, sex unlimited (except pregnant women or those preparing for pregnancy)
2. Clinical diagnosis and imaging () were consistent with head and neck venous malformations
3. Participants volunteered to participate in the trial and signed an informed consent form.

Exclusion Criteria:

1. People with serious systemic diseases, including heart disease, high blood pressure, diabetes, etc. , that are not under control. Heart Attack: 1. Recent frequent attacks of angina. 2. Recent history of myocardial infarction 3. Cardiac function grade iii-iv or with symptoms of sitting breathing, cyanosis, jugular venous distension, lower limb edema, etc. . 4. Heart disease complicated with hypertension 5. Type II or III Type II atrioventricular block, double bundle branch block, as syndrome, diabetes: blood sugar control in 8.88 mmol/L above, hypertension: after taking medicine blood pressure can not be controlled in the normal range namely systolic pressure below 140 mmhg, diastolic pressure below 90 mmhg)
2. Patients who are unable to follow up on time;
3. Persons who are mentally ill or have mental disorders;
4. The patient or his/her authorized person is unwilling to sign a written informed consent or comply with the protocol

Where this trial is running

Jinan, Shandong

• Shandong University Qilu Hospital — Jinan, Shandong, China (Recruiting)

Study contacts

• Principal investigator: shaohua liu, Doctoral — Shandong University Qilu Hospital
• Study coordinator: shaohua liu, Doctoral

Conditions Venous Malformation