Clinical trial NCT03649113: Percutaneous Sclerotherapy of Symptomatic Liver Hemangioma With Bleomycin
Official title: Percutaneous Sclerotherapy of Symptomatic Liver Hemangioma With Bleomycin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hemangioma Liver
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Clinical trials with a single arm investigating the safety and efficacy of percutaneous sclerotherapy of hepatic hemangiomas with the mixture of Bleomycin and Lipiodol
Primary purpose: TREATMENT

Brief summary: Percutaneous sclerotherapy is currently a widely used treatment for subcutaneous low-flow vascular malformations. Considered as a low-flow vascular malformation, symptomatic liver hemangiomas could also theoretically be safely and effectively treated by percutaneous sclerotherapy with a mixture of Bleomycin and Lipiodol. The safety and efficacy of percutaneous sclerotherapy was firstly introduced by the investigator's investigators in 5 patients in a pilot study. The aim of this study is to design and conduct a study to evaluate the safety and efficacy of percutaneous sclerotherapy in a larger sample size with a long term follow-up.

Detailed description: Twenty-five patients with symptomatic liver hemangioma will be enrolled after an informed consent being obtained. Patients' symptoms related to liver mass, including the pain severity being measured by visual analogue scale, discomfort, early satiety, or nausea will be recorded. Liver function tests, coagulation tests, and complete blood count will be checked before the intervention. A triple phase abdominal CT scan with the administration of intravenous contrast medium will also be performed before the procedure. Exclusion criteria include hepatic or renal impairment, abdominal symptoms unrelated to a liver mass, uncorrectable coagulopathy, lung fibrosis, allergy to contrast media, systemic infection, liver abscess, and biliary obstruction.

Patients will be sufficiently hydrated with normal saline before the procedure. Corticosteroid and prophylactic antibiotics will be administered before the procedure. Antibiotics will be continued for 3 days after the procedure.

The liver mass will be punctured under guidance of ultrasonography with a 20- or 22-gauge Chiba needle. Contrast medium will be injected under fluoroscopy guidance to assess any possible communication with the biliary tree and to evaluate the amount of sclerosing agent which could be safely injected. Then, the mixture of Bleomycin (Bleocin-S; Korea United Pharm Inc., South Korea) and Lipiodol (Ultra-Fluid, Guerbet, France) will be slowly injected under continuous guidance of fluoroscopy. No more than 45 units of Bleomycin and 15 cc of Lipiodol will be injected in a single session.

Any complication taking place during and within 30 days after the procedure will be recorded. Liver function tests, coagulation tests, and complete blood count will be repeated the day after the procedure, and 6 months after the procedure. Also, a triple phase abdominal CT scan will be repeated in 6 months, and 12 months after the intervention. The patients' symptoms will be asked by phone after 12 months. The changes in lesion size on CT scan and in patients' symptoms will be evaluated.

Eligibility criteria: Inclusion Criteria:

* patients with symptomatic liver hemangioma

Exclusion Criteria:

* hepatic or renal impairment
* abdominal symptoms unrelated to a liver mass
* uncorrectable coagulopathy
* lung fibrosis
* allergy to contrast media
* systemic infection
* liver abscess
* biliary obstruction

Primary outcomes:
measure: Change in patient satisfaction assessed by the Visual Analog Scale (VAS) after 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of major adverse events
timeFrame: During the procedure and within 30 days after the procedure
measure: Change in hemangioma size
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Imam Khomeini Hospital Complex, Tehran University of Medical Sciences
Study officials:
affiliation: Tehran University of Medical Sciences, Tehran, Iran
name: Hadi Rokni Yazdi, MD
role: STUDY_CHAIR
References:
citation: Ayoobi Yazdi N, Dashti H, Batavani N, Borhani A, Shakiba M, Rokni Yazdi H. Percutaneous Sclerotherapy for Giant Symptomatic Liver Hemangiomas: A Pilot Study. J Vasc Interv Radiol. 2018 Feb;29(2):233-236. doi: 10.1016/j.jvir.2017.10.009.
citation: van der Vleuten CJ, Kater A, Wijnen MH, Schultze Kool LJ, Rovers MM. Effectiveness of sclerotherapy, surgery, and laser therapy in patients with venous malformations: a systematic review. Cardiovasc Intervent Radiol. 2014 Aug;37(4):977-89. doi: 10.1007/s00270-013-0764-2. Epub 2013 Nov 7.
citation: Negrier C, Delmas MC, Ranchin B, Cochat P, Dechavanne M. Decreased factor XII activity in a child with nephrotic syndrome and thromboembolic complications. Thromb Haemost. 1991 Oct 1;66(4):512-3. No abstract available.
citation: Blaise S, Charavin-Cocuzza M, Riom H, Brix M, Seinturier C, Diamand JM, Gachet G, Carpentier PH. Treatment of low-flow vascular malformations by ultrasound-guided sclerotherapy with polidocanol foam: 24 cases and literature review. Eur J Vasc Endovasc Surg. 2011 Mar;41(3):412-7. doi: 10.1016/j.ejvs.2010.10.009. Epub 2010 Dec 15.
citation: Mathur NN, Rana I, Bothra R, Dhawan R, Kathuria G, Pradhan T. Bleomycin sclerotherapy in congenital lymphatic and vascular malformations of head and neck. Int J Pediatr Otorhinolaryngol. 2005 Jan;69(1):75-80. doi: 10.1016/j.ijporl.2004.08.008.
citation: Vilgrain V, Boulos L, Vullierme MP, Denys A, Terris B, Menu Y. Imaging of atypical hemangiomas of the liver with pathologic correlation. Radiographics. 2000 Mar-Apr;20(2):379-97. doi: 10.1148/radiographics.20.2.g00mc01379.