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Completed

NCT Number: NCT03649113

Percutaneous Sclerotherapy of Symptomatic Liver Hemangioma With Bleomycin

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.

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Key information

Conditions

Hemangioma Liver

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Imam Khomeini Hospital Complex, Tehran University of Medical Sciences

Tehran, 1419733141, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sclerotherapy arm

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Acronym: Hemangioma

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Aug 28, 2018
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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