An observational study in Lymphangioma and Lymphatic Malformations, sponsored by National Children's Hospital, Vietnam. Completed at 1 site in Vietnam. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2025-04-24.
Sponsored by National Children's Hospital, Vietnam · Observational
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.
Lymphatic malformations (LM), often referred to as lymphangiomas, are a form of vascular malformation that arises due to the abnormal development of the lymphatic system. These benign but locally invasive lesions are one of the most common vascular anomalies in children. The highest incidence of lymphangiomas is seen in the head and neck region, where they can cause a range of serious complications such as respiratory obstruction, dysphagia (difficulty swallowing), and nerve compression. Less commonly locations of lymphangiomas include axilla, abdomen, thorax, groin, and extremities which could cause bleeding, compression of adjacent structures, and visible deformity, pain and discomfort. Left untreated, these malformations can lead to significant morbidity and functional impairment, as well as severe cosmetic disfigurement, particularly in pediatric patients.
Historically, surgical excision has been the primary treatment for lymphangiomas. However, this approach carries several risks, including damage to surrounding vital structures such as nerves and blood vessels, high recurrence rates due to incomplete excision, and unsightly scars. Over the last few decades, sclerotherapy (ST) has emerged as a less invasive, more favorable alternative that reduces morbidity while achieving superior cosmetic outcomes. Among various sclerosing agents, Bleomycin has gained popularity due to its mechanism of disrupting cellular functions in the abnormal lymphatic endothelial cells, leading to regression of the lesion.
Since its introduction to Vietnam in 2016, Bleomycin has been increasingly used as an adjunctive therapy for lymphangiomas. Despite its growing clinical application, there is a significant lack of comprehensive studies evaluating the safety, efficacy, and long-term outcomes of Bleomycin sclerotherapy in treating pediatric lymphatic malformations, particularly in the Vietnamese population. To date, no large-scale studies have assessed the clinical impact and quality-of-life outcomes of Bleomycin treatment for LM in children within the Vietnamese context. This study seeks to fill this gap in knowledge by comprehensively evaluating the long-term outcomes of intralesional Bleomycin injections in pediatric patients with lymphatic malformations treated at the National Children's Hospital in Vietnam.
The primary objective of this study is to evaluate the safety, efficacy, and long-term outcomes of intralesional Bleomycin injection for pediatric patients diagnosed with lymphatic malformations. The research will focus on both clinical success (such as reduction in lesion size and recurrence rates) and the cosmetic and health-related quality of life (QoL) improvements observed in the patients post-treatment. The study will also examine whether Bleomycin can effectively reduce the need for additional surgical interventions, thus improving both functional and aesthetic outcomes for these children.
This retrospective study will involve a cohort of more than 800 pediatric patients diagnosed with lymphatic malformations and treated with Bleomycin injections at the National Children's Hospital between 2018 and 2022. These patients will be evaluated for safety and efficacy by reviewing their medical records, monitoring for complications, and assessing the recurrence rates of lymphangiomas after treatment. Additionally, long-term cosmetic outcomes will be evaluated using validated patient-reported measures, such as the Patient Scar Assessment Questionnaire (PSAQ), and health-related quality of life will be assessed using the Short Form-36 (SF-36) health survey.
The study aims to assess the safety and efficacy of Bleomycin injection in pediatric patients diagnosed with lymphatic malformations at the National Children's Hospital between 2018 and 2022. This will be done by focusing on post-treatment complications and recurrence rates. Furthermore, the research intends to evaluate the long-term clinical outcomes, including lesion regression, recurrence, and the need for additional interventions. This will help assess the impact of Bleomycin on lesion size, post-treatment complication rates, and the overall clinical success of the intervention.
Another important goal of the study is to analyze the cosmetic outcomes and health-related quality of life in pediatric patients treated with Bleomycin sclerotherapy. The study will use standardized assessment tools like the PSAQ for scarring and the SF-36 for overall health outcomes. These tools will help quantify the patient-reported perception of treatment effects, including both cosmetic outcomes (scar appearance and symptoms) and overall well-being.
Additionally, the study will investigate the role of Bleomycin as a standalone treatment or in combination with surgical interventions to enhance treatment success while minimizing risks and complications associated with invasive procedures. By comparing these approaches, the research aims to determine if Bleomycin alone is sufficient or if a multimodal approach is more effective in treating lymphangiomas.
The results of this study will provide important insights into the feasibility and effectiveness of Bleomycin as an alternative to traditional surgical excision for the treatment of pediatric lymphangiomas. By examining both objective clinical outcomes and subjective patient-reported outcomes, such as quality of life and scar perception, this research will offer a comprehensive understanding of the benefits and challenges of using Bleomycin for this indication. The findings are expected to influence the clinical management of lymphangiomas in pediatric patients, offering evidence-based recommendations on the use of Bleomycin as a safe, effective, and cosmetically favorable treatment option.
Additionally, the study will contribute to filling the gap in local research on the use of Bleomycin for lymphatic malformations in Vietnam, a country where the clinical application of this agent has been relatively new and unstudied. The results of this research could lead to the establishment of evidence-based guidelines for Bleomycin treatment in the Vietnamese healthcare system, supporting its wider adoption as a standard therapy for lymphangiomas.
The study will be conducted with a strict ethical framework, ensuring that all patients and their families provide informed consent before participation, and that their privacy and confidentiality are strictly maintained. Data will be anonymized and stored securely throughout the research process. The findings will be disseminated through peer-reviewed scientific journals, with a particular focus on journals related to pediatric surgery, dermatology, and vascular anomalies, which could help raise awareness of Bleomycin's potential as a viable therapeutic option in the management of lymphangiomas.
In conclusion, this study will not only provide critical clinical data on the efficacy and safety of Bleomycin for treating pediatric lymphangiomas, but it will also enhance our understanding of the long-term cosmetic outcomes and quality of life improvements associated with this treatment. By offering a minimally invasive, less risky alternative to surgical excision, Bleomycin could revolutionize the management of lymphatic malformations in children, improving their health outcomes and overall well-being while minimizing the physical and psychological impact of the disease.
13 studies on the registry are indexed under Lymphangioma; 5 are open to participants now.
Browse Lymphangioma studies →National Children's Hospital, Vietnam is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
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The population of pediatric patients for this study will consist of children under the age of 18 who have been diagnosed with lymphangiomas (lymphatic malformations). These patients will have a variety of lesion locations, including the head and neck, axilla (armpit), abdomen, thorax (chest), groin, or extremities. The age range will encompass infants, children, and adolescents. They might or might not have received previous treatment with Bleomycin or other interventions for lymphatic malformations. Additionally, they might or might not serious comorbidities such as uncontrolled systemic diseases or immunosuppressive conditions. The cohort will be selected from the patient population at the National Children's Hospital, and participants will be enrolled based on a confirmed diagnosis of lymphangioma from 2018 to 2022.
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Exclusion Criteria:
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort consists of pediatric patients under the age of 18, diagnosed with lymphangiomas (lymphatic malformations), treated at the National Children's Hospital between 2018 and 2022. The lymphangiomas in this group are most commonly located in the head and neck, but may also occur, though less frequently, in the axilla, abdomen, thorax, groin, and extremities. The patients included in this cohort were selected based on their diagnosis of lymphangiomas without serious comorbidities that could complicate treatment or outcomes of the sclerotherapy. These patients were managed or observed during the study period, and the cohort represents a diverse age range of children under 18.
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.
Change in Lesion Size
The degree of lesion size change will be measured to assess the efficacy of intralesional Bleomycin injection. This will be evaluated through clinical examination and imaging techniques (e.g., ultrasound or MRI) to determine the extent of regression of the lymphangioma.
Time frame: Through study completion, an average of 5 years
Recurrence Rate
This outcome will track the recurrence rate of lymphangiomas after treatment with Bleomycin. Recurrence is defined as the reappearance or regrowth of the lesion after an initial reduction in size following treatment.
Time frame: Through study completion, an average of 5 years
Adverse Reactions
The safety of the Bleomycin treatment will be assessed by monitoring adverse reactions, including infection, bleeding, swelling, or allergic reactions at the injection site, as well as any systemic side effects.
Time frame: 1 week after each injection
Number of Injections Required for Remission
The number of Bleomycin injections required to achieve remission (defined as significant size reduction or complete resolution of the lesion) will be recorded. This will help assess the treatment protocol's efficiency and the typical treatment burden for patients.
Time frame: Through study completion, an average of 5 years
Proportion of patients requiring additional interventions
This outcome will track the proportion of patients requiring additional interventions (e.g., surgical excision or further sclerotherapy sessions) after the initial Bleomycin treatment. The goal is to determine if Bleomycin alone is sufficient to treat the lymphangiomas or if supplementary interventions are necessary.
Time frame: Through study completion, an average of 5 years
PSAQ score - Cosmetic Outcomes and Scar Perception
Cosmetic outcomes and patient scar perception were evaluated using the Patient Scar Assessment Questionnaire (PSAQ). This validated tool includes multiple subscales assessing appearance, symptoms, consciousness, and satisfaction with appearance. Each subscale is scored on a 4-point Likert scale, with individual item scores ranging from 1 to 4, where lower scores indicate better cosmetic outcomes and greater patient satisfaction. The minimum total score is 18, and the maximum is 72, with lower total scores representing more favorable scar outcomes.
Time frame: Through study completion, an average of 5 years
SF-36 score - Health-Related Quality of Life (QoL)
Health-related quality of life was assessed using the Short Form-36 Health Survey (SF-36), a validated instrument comprising 36 items across eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health perceptions. Scores for each domain range from 0 to 100, with higher scores indicating better health-related quality of life. Both individual domain scores and composite physical and mental component summary scores were analyzed.
Time frame: Through study completion, an average of 5 years
Follow-Up Time
The duration of follow-up visits post-treatment will be tracked to monitor for recurrence or complications. Follow-up time will also help assess the long-term effectiveness of Bleomycin treatment.
Time frame: Through study completion, an average of 5 years
Time to Regrowth of Lesion
This outcome will measure the time to regrowth of the lymphangioma lesion after initial Bleomycin treatment. The time period between treatment and the first signs of regrowth will be monitored to evaluate the durability of the treatment.
Time frame: Through study completion, an average of 5 years
Plan to share: No
Ran from Jan 2018 to primary completion in Dec 2022, 59 months.
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National Children's Hospital, Vietnam