Bleomycin as an Effective and Curative Adjunct Therapy for Lymphangioma

Summary

Lymphatic malformations (LM), or lymphangiomas, are common vascular anomalies in children, most often occurring in the head and neck, less commonly in the axilla, abdomen, thorax, groin, and extremities. These benign but locally invasive lesions can cause complications such as respiratory issues, difficulty swallowing, nerve compression, bleeding, and cosmetic disfigurement. Treatment traditionally involves surgical excision, but this approach carries risks such as nerve damage, high recurrence, and poor cosmetic results. In recent years, sclerotherapy, specifically Bleomycin injection, has emerged as a less invasive alternative, offering potential benefits like reduced recurrence and better cosmetic outcomes.

Since its introduction in Vietnam in 2016, Bleomycin has been used to treat LM, but comprehensive studies on its safety, efficacy, and long-term outcomes in pediatric patients are lacking. This study aims to fill this gap by evaluating the effectiveness of intralesional Bleomycin injections in children with LM treated at the National Children's Hospital between 2018 and 2022.

The study will assess the safety, efficacy, and long-term outcomes of Bleomycin, focusing on lesion size reduction, recurrence rates, and cosmetic and health-related quality of life (QoL) improvements. The retrospective study will involve more than 800 pediatric patients and use tools like the Patient Scar Assessment Questionnaire (PSAQ) and Short Form-36 (SF-36) health survey to evaluate cosmetic outcomes and overall well-being.

The research will also compare the effectiveness of Bleomycin alone versus in combination with surgery, examining whether Bleomycin can reduce the need for additional interventions. By offering a comprehensive evaluation of both clinical and patient-reported outcomes, the study aims to establish Bleomycin as a viable, minimally invasive treatment option for pediatric LM, improving both clinical and cosmetic outcomes for these patients.

In addition, this study will provide valuable local data on Bleomycin's use in Vietnam, potentially influencing national treatment guidelines. The results will be disseminated in peer-reviewed journals, contributing to global understanding of Bleomycin's role in managing lymphatic malformations in children.

Conditions

• Lymphangioma
• Lymphatic Malformations

Interventions

DRUG

Sclerotherapy with intralesional bleomycin injection

The intervention studied is intralesional Bleomycin injection, which involves the direct injection of Bleomycin, a chemotherapeutic agent, into the lymphangioma lesions. This minimally invasive procedure is aimed at reducing the size of the lymphangioma by disrupting the abnormal growth of lymphatic vessels. The dosage of Bleomycin is tailored based on the patient's body weight, typically ranging from 1 to 3 mg per kg of body weight per injection. The intervention is distinct from other treatments, such as surgical excision or other sclerotherapy agents, as it specifically utilizes Bleomycin's mechanism of action to induce tissue sclerosis and promote lesion regression without the need for invasive surgery. This intervention may require multiple treatment sessions, depending on the size, location of the lymphangioma, and individual's response to therapy, with the goal of achieving long-term effectiveness and improving cosmetic outcomes.

Sponsors & Collaborators

• National Children's Hospital, Vietnam

  lead OTHER

Principal Investigators

• Quang T Nguyen, M.D. · Department of Pediatric Surgery, The National Hospital of Pediatrics, Hanoi, Vietnam

Eligibility

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-01

Primary Completion

2022-12-31

Completion

2025-02-04

Countries

• Vietnam

Study Locations