Clinical trial · Observational
Bleomycin as an Effective and Curative Adjunct Therapy for Lymphangioma
Safety, Efficacy, and Long-Term Outcomes of Intralesional Bleomycin Injection as an Adjunctive Therapy for Pediatric Lymphatic Malformations: A Retrospective Study on Cosmetic and Health-Related Quality of Life Improvements.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphangioma | Lymphangioma | ONTOLOGY_EXACT | 0.98 |
| Lymphatic Malformations | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sclerotherapy with intralesional bleomycin injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Pediatric Patients with Lymphangiomas Treated with Intralesional Bleomycin
- description
- 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.
- interventionNames
- Drug: Sclerotherapy with intralesional bleomycin injection
Primary outcomes (7)
- measure
- Change in Lesion Size
- timeFrame
- Through study completion, an average of 5 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age: Pediatric patients under the age of 18 years. * Diagnosis: Confirmed diagnosis of lymphangioma (lymphatic malformation). * Location of Lesions: Lymphangiomas located in the head and neck, axilla, abdomen, thorax, groin, or extremities. * Treatment History: No prior treatment with Bleomycin for lymphangioma. * Health Status: No serious comorbidities or medical conditions that could interfere with the study or treatment process. * Informed Consent: Patients (or their legal guardians) provide informed consent to participate in the study. Exclusion Criteria: * Age: Patients over the age of 18 years. * Pregnancy: Pregnant or breastfeeding patients. * Other Treatments: Patients who have received prior treatments with Bleomycin for lymphangioma. * Severe Comorbidities: Presence of serious comorbidities (e.g., uncontrolled cardiovascular disease, active infections) that may interfere with the study or treatment process. * Allergy: Known allergy or hypersensitivity to Bleomycin or any of its components. * Active Infections: Patients with active local or systemic infections at the time of enrollment. * Immunosuppression: Immunocompromised patients (due to illness or medications).
References
Publications (13)
- BACKGROUNDAcevedo JL, Shah RK, Brietzke SE. Nonsurgical therapies for lymphangiomas: a systematic review. Otolaryngol Head Neck Surg. 2008 Apr;138(4):418-24. doi: 10.1016/j.otohns.2007.11.018. PMID 18359347
- BACKGROUNDContopoulos-Ioannidis DG, Karvouni A, Kouri I, Ioannidis JP. Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review. BMJ. 2009 Jan 12;338:a3006. doi: 10.1136/bmj.a3006. PMID 19139138
- BACKGROUNDWassef M, Blei F, Adams D, Alomari A, Baselga E, Berenstein A, Burrows P, Frieden IJ, Garzon MC, Lopez-Gutierrez JC, Lord DJ, Mitchel S, Powell J, Prendiville J, Vikkula M; ISSVA Board and Scientific Committee. Vascular Anomalies Classification: Recommendations From the International Society for the Study of Vascular Anomalies. Pediatrics. 2015 Jul;136(1):e203-14. doi: 10.1542/peds.2014-3673. Epub 2015 Jun 8. PMID 26055853
- RESULTPorwal PK, Dubey KP, Morey A, Singh H, Pooja S, Bose A. Bleomycin Sclerotherapy in Lymphangiomas of Head and Neck: Prospective Study of 8 Cases. Indian J Otolaryngol Head Neck Surg. 2018 Mar;70(1):145-148. doi: 10.1007/s12070-017-1243-x. Epub 2018 Jan 8. PMID 29456959
- RESULTAmeh EA, Nmadu PT. Cervical cystic hygroma: pre-, intra-, and post-operative morbidity and mortality in Zaria, Nigeria. Pediatr Surg Int. 2001 Jul;17(5-6):342-3. doi: 10.1007/s003830000558. PMID 11527161
- RESULTBawazir OA, Bawazir R, Bawazir A, Kausar N, Said H. Efficacy and Clinical Outcomes of Bleomycin in the Treatment of Lymphangiomas: A Multicenter Experience. Dermatol Surg. 2021 Jul 1;47(7):948-952. doi: 10.1097/DSS.0000000000002976. PMID 33625132
- RESULTYang Y, Sun M, Ma Q, Cheng X, Ao J, Tian L, Wang L, Lei D. Bleomycin A5 sclerotherapy for cervicofacial lymphatic malformations. J Vasc Surg. 2011 Jan;53(1):150-5. doi: 10.1016/j.jvs.2010.07.019. Epub 2010 Sep 16.