Results of Ultrasonography-guided Intralesional Bleomycin Sclerotherapy for Treatment of Macrocystic Lymphangioma in Children and Comparison with traditional surgical methods
Results of Ultrasonography-guided Intralesional Bleomycin Sclerotherapy for Treatment of Macrocystic Lymphangioma in Children
Design
Two-group clinical trial, with parallel groups, without blinding, not randomized, on 20 patients. Excel software rand function was used for randomization.
Settings and conduct
This research is carried out in collaboration with professors of different wards of Tabriz Children's Hospital (surgery, ENT, oncology, radiology and pharmacist center). Sampling method is randomly selected from patients referred to surgical and ENT clinics in Tabriz Childeren Hospital.
Participants/Inclusion and exclusion criteria
Cysts in the lymphatic system in different parts of the body: entry
Parental consent: entry
Lymphangioma with small cysts: exit
Previous surgery: exit
Intervention groups
The first group treats cysts with surgery
The second group is treatment withIntralesional Sclerotherapy
Main outcome variables
Removal of lymphangioma with surgery or sclerotherapy
General information
Reason for update
Acronym
لنفانژیوم
IRCT registration information
IRCT registration number:IRCT20150114020663N5
Registration date:2021-09-13, 1400/06/22
Registration timing:prospective
Last update:2021-09-13, 1400/06/22
Update count:0
Registration date
2021-09-13, 1400/06/22
Registrant information
Name
Davoud Badebarin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3526 2257
Email address
badebarind@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Results of Ultrasonography-guided Intralesional Bleomycin Sclerotherapy for Treatment of Macrocystic Lymphangioma in Children and Comparison with traditional surgical methods
Public title
Intralesional Bleomycin Sclerotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cysts in the lymphatic system in different parts of the body: entry
Parental consent: entry
Exclusion criteria:
Lymphangioma with small cysts
Previous surgery
Age
From 1 day old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Treatment of large lymphangiomas
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
no.44, Golsar Alley, Golbad Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165678691
Approval date
2021-08-02, 1400/05/11
Ethics committee reference number
IR.TBZMED.REC.1400.391
Health conditions studied
1
Description of health condition studied
Lymphangioma
ICD-10 code
D18.1
ICD-10 code description
Lymphangioma, any site
Primary outcomes
1
Description
Recurrence of lymphangioma
Timepoint
6 month
Method of measurement
Sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intralesional Bleomycin Sclerotherapy: In patients in this group, injections are performed by one person and under ultrasound guide in the operating room and under general anesthesia. After a general examination of the cyst with examination and ultrasound in the operating room, first the fluid contents of the cysts are repeatedly emptied under the ultrasound guide by a 10 cc syringe and needle number 21. While the needle head is in the same place inside the cyst and the control is done by sono, the sclerosing substance is injected at the site. The required dose is 0.5 units per kilogram of body weight. The maximum amount of injection to prevent possible complications is 10 units of sclerosing material. The ratio of the amount of aspirated fluid to the volume of the sclerosing substance is 5: 1. For every 5 cc of aspirated fluid, one cc of fluid containing sclerosant is injected into the lesion. If a larger volume of sclerosing agent is needed, it is postponed to the second session, which is done 4 to 6 weeks later. For all cysts, this amount will be used in divided doses according to weight.Each vial of bleomycin contains 15 units of active ingredient that is diluted with normal saline to the desired volume and composition. 10 kg of 30 cc of aspiration from cyst V requires 5 units of 6 cc of bleomycin, for this patient a 15-unit vial with 18 cc of dissolved normal saline and 6 cc (containing 5 units of bleomycin). Blomycin is manufactured by Salius in India.
Category
Treatment - Other
2
Description
Intervention group: Patients in this group undergo macrocystic resection and drainage by a single surgeon. After the operation, the monitored patients are evaluated for possible complications. At the end of six months, patients are evaluated for recurrence and late complications.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Chideren Hospital
Full name of responsible person
Davoud Badebarin
Street address
No.44, Golsar Alley. Golbad Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5165678691
Phone
+98 41 3325 2272
Email
badebarind@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohamad Samiei
Street address
Daneshgah Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5165788541
Phone
+98 41 3526 2257
Email
dbadebarin@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Davoud Badebarin
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Surgery
Street address
No.44,Golsar Alley.Golbad Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5165678691
Phone
+98 41 3325 2272
Email
badebarind@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Davoud Badebarin
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
pediatric Surgery
Street address
No. 44. Golsar alley. Golbad Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5165678691
Phone
+98 41 3325 2272
Email
badebarind@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Davoud Badebarin
Position
Pediatric Surgery Sub-specialist.
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Department of Surgery, Imam Reza Hospital, Daneshgah Street, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5165678691
Phone
+98 41 3334 1317
Fax
Email
badebarind@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD