Percutaneous Sclerotherapy of Symptomatic Liver Hemangioma With Bleomycin

NCT03649113 | Completed Phase 1

• 1 other identifier: Liver Hemangioma Sclerotherapy
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemangioma Liver

Outcome Measures

Primary Outcomes (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).

  6 months

Secondary Outcomes (2)

• Incidence of major adverse events

  During the procedure and within 30 days after the procedure

• Change in hemangioma size

  6 months

Study Arms (1)

sclerotherapy arm

EXPERIMENTAL

Patients with symptomatic liver hemangioma undergoing sclerotherapy (percutaneous injection) with 45 units of Bleomycin once during the procedure

Procedure: sclerotherapy arm

Interventions

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.

sclerotherapy arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with symptomatic liver hemangioma

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Imam Khomeini Hospital Complex, Tehran University of Medical Sciences

Tehran, 1419733141, Iran

Location

Related Publications (6)

• 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.

  PMID: 29414196 BACKGROUND

• 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.

  PMID: 24196269 BACKGROUND

• 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.

  PMID: 1796406 BACKGROUND

• 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.

  PMID: 21111641 BACKGROUND

• 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.

  PMID: 15627451 BACKGROUND

• 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.

  PMID: 10715338 BACKGROUND

Study Officials

• Hadi Rokni Yazdi, MD

  Tehran University of Medical Sciences, Tehran, Iran

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinical trials with a single arm investigating the safety and efficacy of percutaneous sclerotherapy of hepatic hemangiomas with the mixture of Bleomycin and Lipiodol

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 28, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: July 1, 2020
• Last Updated: October 8, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)