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Trial Title:
Use of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients
NCT ID:
NCT06437158
Condition:
Lymphatic Malformation
Conditions: Official terms:
Lymphangioma
Lymphatic Abnormalities
Congenital Abnormalities
Bleomycin
Conditions: Keywords:
Lymphatic Malformation
Bleomycin
Sclerotherapy
Intracystic injection
High-dose concentrations
Low-dose concentrations
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
The investigators aim to compare the efficacy and safety of different concentrations of
Bleomycin in the sclerotherapy of lymphatic malformations for pediatric patients.
Primary purpose:
Treatment
Masking:
Double (Participant, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Bleomycin
Description:
To validated the efficacy and safety of different concentrations of Bleomycin in the
sclerotherapy of lymphatic malformations for pediatric patients
Arm group label:
High-dose Concentrations (2mg/ml) of Bleomycin
Arm group label:
Low-dose Concentrations (1mg/ml) of Bleomycin
Other name:
Zeocin
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
1/4000-1/2000, 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Male or female participants less than 14 years of age at the time of informed
consent/assent form was signed.
- Participants whose parents have voluntarily given written consent and participants
who provided assent (if applicable) after the study has been explained to them.
- Participants with LMs of all sites measured and confirmed via imaging at screening,
with rapid progression, resluting in obvious symptoms or dysfunction, which could
not be radically resected and could be treated by sclerotherapy.
Exclusion Criteria:
- Penicillin allergy.
- Vascular tumors or combined vascular malformations.
- Participants who may have had surgical or sclerotherapy treatment by other
hardeners.
- LMs growing slowly, without obvious symptoms or dysfunction, which does not need to
be treated prematurely.
Gender:
All
Minimum age:
N/A
Maximum age:
14 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi Ji, Ph.D.
Phone:
+8618980606865
Email:
jijiyuanyuan@163.com
Contact backup:
Last name:
Min Yang, M.D.
Phone:
+8615928411140
Email:
hx2014bsym@163.com
Start date:
March 8, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
West China Hospital
Agency class:
Other
Source:
West China Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06437158
