Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437158
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2023-12-19
Brief Title:
Use of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients
Sponsor:
West China Hospital
Organization:
West China Hospital
Study Overview
Official Title:
Efficacy and Safety of Different Concentrations of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Bleomycin has nowadays been more and more widely used in the sclerotherapy of LMs which has been proven to be primarily dose dependent The investigators aim to compare the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of LMs for pediatric patients
Detailed Description:
Lymphatic malformations LMs are vascular anomalies that arise from abnormal embryonic development of the lymphatic system and might present as dilated lymphatic channels or cysts lined by lymphatic endothelial cells With an estimated incidence of approximately 14000-12000 LMs can occur at any site in the lymphatic system in which head neck and axilla were mostly detected and have been reported to account for over 75 Based on the location and size of the lesion and the extent of involvement LMs may be asymptomatic with incidental detection or chronic abdominal pain and distension due to their compression of surrounding structures or critical and even fatal secondary to their volvulus hemorrhage infection and rupture Surgical excision is a definitive treatment for LMs while it may be difficult at times because of the infiltrative nature of the lesions leading to a high incidence of complications like vital organ injuries nerve injuries bleeding infection scar formation and recurrences Sclerotherapy is a simpler alternative to tedious surgical excision treatment for LMs and avoids the complications related to surgery As an anticancer drug extracted from Streptomyces verticillus Bleomycin has been more and more widely used in the sclerotherapy of LMs for pediatric patients which has been proven to be primarily dose dependent However the optimum concentration of Bleomycin in the sclerotherapy of LMs for pediatric patients has not been strictly validated due to the lack of high-quality RCT studies The investigators aim to compare the efficacy and safety of different concentrations of Bleomycin in the sclerotherapy of LMs for pediatric patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None