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IRCT20150114020663N5 IRCT 2021-09-13 Tabriz University of Medical Sciences Intralesional Bleomycin Sclerotherapy لنفانژیوم Results of Ultrasonography-guided Intralesional Bleomycin Sclerotherapy for Treatment of Macrocystic Lymphangioma in Children and Comparison with traditional surgical methods 2021-09-23 anticipated 20 Complete https://irct.ir/trial/58652 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Treatment of large lymphangiomas. N/A Lymphangioma. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Davoud Badebarin
No.44,Golsar Alley.Golbad Ave.
Tabriz Iran (Islamic Republic of) 5165678691 +98 41 3325 2272 badebarind@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Davoud Badebarin
No. 44. Golsar alley. Golbad Ave.
Tabriz Iran (Islamic Republic of) 5165678691 +98 41 3325 2272 badebarind@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Cysts in the lymphatic system in different parts of the body: entry Parental consent: entry 1 day 14 years Both Lymphangioma with small cysts Previous surgery D18.1 Lymphangioma, any site Treatment - Other Treatment - Surgery 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. 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. Recurrence of lymphangioma. Timepoint: 6 month. Method of measurement: Sonography. Tabriz University of Medical Sciences Approved 2021-08-02 Ethics committee of Tabriz University of Medical Sciences no.44, Golsar Alley, Golbad Ave, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)