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Percutaneous Sclerotherapy of Symptomatic Liver Hemangioma With Bleomycin (Hemangioma)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649113
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Hemangioma Liver Procedure: sclerotherapy arm Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
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
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Percutaneous Sclerotherapy of Symptomatic Liver Hemangioma With Bleomycin
Actual Study Start Date : September 15, 2018
Estimated Primary Completion Date : November 15, 2019
Estimated Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks

Arm Intervention/treatment
Experimental: sclerotherapy arm
Patients with symptomatic liver hemangioma undergoing sclerotherapy (percutaneous injection) with 45 units of Bleomycin once during the procedure
Procedure: sclerotherapy arm
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.




Primary Outcome Measures :
  1. Change in patient satisfaction assessed by the Visual Analog Scale (VAS) after 6 months [ Time Frame: 6 months ]

    Pain is subjectively assessed based on a visual analog scale (VAS) before and 6 months after intervention. Change in VAS is recorded.

    VAS is between zero (no pain at all) and 10 (worst pain imaginable).



Secondary Outcome Measures :
  1. Incidence of major adverse events [ Time Frame: During the procedure and within 30 days after the procedure ]
    Incidence of major adverse events that may cause any of the following: A) Require therapy, minor hospitalization (less than 48 hours) B) Require major therapy, unplanned increase in level of care, prolonged hospitalization (more than 48 hours) C) Permanent adverse sequel D) Death

  2. Change in hemangioma size [ Time Frame: 6 months ]
    The size of the hemangioma is assessed on CT scans performed before and 6 months after the procedure. The largest diameter of the hemangioma is measured on axial images.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649113


Contacts
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Contact: Hadi Rokni Yazdi, MD 00989124136470 rokniyaz@tums.ac.ir

Locations
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Iran, Islamic Republic of
Imam Khomeini Hospital Complex, Tehran University of Medical Sciences Recruiting
Tehran, Iran, Islamic Republic of, 1419733141
Contact: Hadi Rokni Yazdi, MD         
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
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Study Chair: Hadi Rokni Yazdi, MD Tehran University of Medical Sciences, Tehran, Iran

Publications:
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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03649113    
Other Study ID Numbers: Liver Hemangioma Sclerotherapy
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Bleomycin
Antibiotics, Antineoplastic
Antineoplastic Agents