Clinical study on the safety and efficacy of fibrin glue combined with local injection of pingyangmycin in the treatment of head and neck venous malformations

A prospective, open-label, single-arm, phase II clinical trial to evaluate the efficacy of pingyangmycin combined with fibrin glue in the treatment of head and neck venous malformations

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100053242

Enrollment

Unknown

Registered

2021-11-17

Start date

2022-06-12

Completion date

Unknown

Last updated

2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Venous Malformation

Interventions

Experimental group:Pingyangmycin combined with local injection of fibrin glue

Eligibility

Sex/Gender

All

Age

1 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Sign the Informed Consent Form (ICF). 2. Meet the diagnostic criteria for venous malformations in the Guidelines for the Diagnosis and Treatment of Hemangiomas and Vascular Malformations (2019 Edition). 3. The patient has lesions measurable under enhanced MRI or (and) electronic laryngoscope or direct vision. 4. The patient has not received other sclerotherapy before receiving combined injection sclerotherapy. 5. Aged 1-70 years. 6. Life expectancy >= 1 year. 7. Patients must have proper organ function: absolute neutrophil count (ANC) (>= 1.5 x 10^9/L); hemoglobin >= 90 g/L; platelets >= 80x10^9/L; total bilirubin = 60 mL/min; baseline albumin >= 28 g/L; normal lung function.

Exclusion criteria

Exclusion criteria: 1. Patients with >= 2 venous malformations in the whole body. 2. Allergic to fibrin glue and (or) Pingyangmycin. 3. Pregnant and lactating patients. 4. Those with severe systemic disease who cannot tolerate general anesthesia surgery, including but not limited to congestive heart failure ([NYHA] class 2), unstable or severe angina, severe acute myocardial infarction within 1 year prior to enrollment, supraventricular or ventricular arrhythmias requiring pharmacological intervention, or QT interval >= 450 msec and >= 470 msec in females. Arterial or venous thrombosis within 6 months. Hypertension not well controlled with antihypertensive drugs (systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 110 mmHg). Proteinuria >= (++) or 24-hour urine total protein > 1.0 g. Abnormal coagulation (INR > 2.0, PT > 16s), bleeding tendency or receiving thrombolytic or anticoagulation therapy. 5. Known to suffer from autoimmune diseases, including but not limited to scleroderma, systemic lupus erythematosus, rheumatoid arthritis, etc. 6. Patients with known scar constitution. 7. Patients with pulmonary fibrosis who meet the diagnostic criteria of the 2018 Guidelines for Pulmonary Interstitial Fibrosis. 8. Patients with known malignant tumors (previous or current). 9. Any other medical, mental or social condition that, in the opinion of the researcher, may impair the rights, safety, welfare or ability of the subject to sign informed consent, to cooperate and to participate in the study, or to interfere with the interpretation of the results.

Design outcomes

Primary

Measure	Time frame
Cure rate;Incidence of adverse reactions;Treatment times;	—

Countries

China

Contacts

Public ContactLei Wenbin

The First Affiliated Hospital of Sun Yat-Sen University

leiwb@mail.sysu.edu.cn+86 13922113299

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026