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NCT06943703Befejeződött

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.

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. ápr. 24.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Megfigyeléses
Résztvevők száma
809 (tényleges)
Első benyújtás
2025. ápr. 6.
Kezdés
2018. jan. 1.
Elsődleges befejezés
2022. dec. 31.
Fő szponzor
National Children's Hospital, Vietnam
NCT-szám
NCT06943703

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Bevont résztvevők: 809
  • 2018. jan. 1. és az elsődleges befejezés (2022. dec. 31.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

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Korábbi kezelés

  • Other Treatments: Patients who have received prior treatments with Bleomycin for lymphangioma.

Más betegség

  • 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).

Életkor

  • Age: Patients over the age of 18 years.

Egyéb

  • Pregnancy: Pregnant or breastfeeding patients.

Kiket keres a vizsgálat

  • 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.

Életkor a regiszterben: - – 18 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Department of Surgery, The National Children Hospital, HanoiHanoiVietnámIsmeretlen állapot

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