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Hemangioma LiverPhase 1HemangiomaNCT03649113

Percutaneous Sclerotherapy of Symptomatic Liver Hemangioma With Bleomycin

A Phase 1 study testing sclerotherapy arm in people with Hemangioma Liver, run by Tehran University of Medical Sciences at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hemangioma Liver
What is being tested?
sclerotherapy arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteIran
Study dates
1 Sep 2018to 1 Jul 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients with symptomatic liver hemangioma

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • Imam Khomeini Hospital Complex, Tehran University of Medical Sciences

    Tehran, 1419733141

Other trials in Iran

About this study

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.

Read the 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.

Being tested
sclerotherapy arm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sclerotherapy armProcedure or surgery

    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.

Study groups in NCT03649113
Study groupRoleWhat they receive
sclerotherapy armExperimentalPatients with symptomatic liver hemangioma undergoing sclerotherapy (percutaneous injection) with 45 units of Bleomycin once during the procedure
Receives: Procedure: sclerotherapy arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in patient satisfaction assessed by the Visual Analog Scale (VAS) after 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).

    Measured: 6 months

Secondary outcomes (2)

  1. Incidence of major adverse events

    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

    Measured: During the procedure and within 30 days after the procedure

  2. Change in hemangioma size

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2018
  2. Study start1 Sep 2018
  3. Primary completion1 Sep 2019
  4. Study completion1 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03649113
Sponsor's protocol ID
Liver Hemangioma Sclerotherapy
Acronym
Hemangioma
Status last verified
Oct 2019
First submitted
19 Jul 2018
Last updated
8 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29414196

  • 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.

    PubMed 24196269

  • 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.

    PubMed 1796406

  • 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.

    PubMed 21111641

  • 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.

    PubMed 15627451

  • 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.

    PubMed 10715338

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing sclerotherapy arm in people with Hemangioma Liver, run by Tehran University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in patient satisfaction assessed by the Visual Analog Scale (VAS) after 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03649113, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.

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