Lipiodol-TACE With Idarubicin Based On a Specific Emulsion Ratio for Hepatocellular Carcinoma
NCT ID: NCT05631613
Last Updated: 2022-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2022-12-28
2023-04-30
Brief Summary
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Detailed Description
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In recent years, foreign scholars have conducted a series of explorations in the treatment of hepatocellular carcinoma with lipiodol-idarubicin emulsion, and have obtained positive results.
However, in China, idarbicin has just been applied to TACE.Many interventional physicians are accustomed to directly use contrast agents to dissolve anthracyclines in order to improve tracer performance of chemotherapeutic agent-lipiodol emulsion under X-ray and reduce intraoperative reflux and misembolization. Meanwhile, due to the high density of the nonionic contrast media, the lipiodol emulsion can be deposited in the lesion for a long time. The Clinical Practice Guidelines for transcatheter arterial chemoembolization (TACE) Treatment of hepatocellular carcinoma in China (2021 edition) also recommended to prepare the chemotherapeutic drug-lipiodol emulsion according to the standard of " dissolving drug in nonionic contrast agent then mixed with lipiodol to make an emulsion with a ratio of 1:2".
At present, there is a lack of detailed objective data on the complete physical properties of the lipiodol-idarubicin emulsion, and some physicians and centers even make the emulsion based only on their habits and preferences.These all may affect the physical properties of the lipiodol emulsion, including intraoperative stability and viscosity of the emulsion, then eventually affect the operation of surgeon and the release behavior of chemotherapeutic drugs, and ultimately influence the efficacy of TACE.Therefore, the purpose of this prospective, observational study is to evaluate properties of lipiodol-idarubicin emulsion mixed with the best regimen obtained in vitro study, including stability, viscosity，visibility under X-ray and deposition, in order to maximize the efficacy of idarubicin-cTACE for HCC.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Water for Injection -Idarubicin -Lipiodol
Idarubicin is first dissolved in water for injection to make a solvent of
1mg/ml, which is then mixed with lipiodol to make an emulsion with a ratio of 1:2. Lipiodol-idarubicin emulsion is slowly injected, followed by embolization with embolic agents.
cTACE(conventional transarterial chemoembolization)
transarterial chemoembolization with lipiodol-idarubicin emulsion
Nonionic Contrast Agent -Idarubicin -Lipiodol
Idarubicin is first dissolved in nonionic contrast agent to make a solvent of
1mg/ml, which is then mixed with lipiodol to make an emulsion with a ratio of 1:2. Lipiodol-idarubicin emulsion is slowly injected, followed by embolization with embolic agents.
cTACE(conventional transarterial chemoembolization)
transarterial chemoembolization with lipiodol-idarubicin emulsion
Interventions
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cTACE(conventional transarterial chemoembolization)
transarterial chemoembolization with lipiodol-idarubicin emulsion
Eligibility Criteria
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Inclusion Criteria
2. One of the following cases:
1）CNLC stage IIb-IIIa, part of stage IIIb, and CNLC stage Ib and IIa patient who is unable or unwilling to receive surgical treatment due to other reasons (such as advanced age, severe liver cirrhosis, etc.); 2).Child-Pugh class A or B; 3).ECOG PS of 0 - 2; 4)The main portal vein has not been completely obstructed, with abundant collateral vessels, or restore the blood flow by portal vein stent placement 3.At least one measurable lesion (enable to assess lipiodol deposition); 4.Be willing to participate in this study.
Exclusion Criteria
2. Incomplete clinical and imaging data
3. Poor image quality or other difficulties in assessing intratumoral lipiodol deposition, including:
1\) A large amount of lipiodol was deposited around the lesion 2) Diffuse tumor distribution 3) Intratumoral lipiodol deposition from previous TACE 4) Metal artifacts from previous operations
18 Years
80 Years
ALL
No
Sponsors
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Zhongda Hospital
OTHER
Responsible Party
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Gao-jun Teng
President
Principal Investigators
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Hai-Dong Zhu, MD
Role: PRINCIPAL_INVESTIGATOR
Zhongda hospital, Southeast university, Nanjing, China
Locations
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Zhongda Hospital, Southeast University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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References
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Other Identifiers
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Idarubicin-cTACE
Identifier Type: -
Identifier Source: org_study_id