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      Development of a Novel Endovascular Brachytherapy Stent: A Proof-of-concept Study

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          Abstract

          Background and Aims

          Endovascular implantation of iodine-125 ( 125I) seeds strand combined with stent is an effective method of treatment for portal vein tumor thrombosis. The aim of this study was to develop a novel endovascular brachytherapy stent (EVB-Stent) and to evaluate its feasibility of use.

          Methods

          An EVB-Stent was implanted into the main portal vein (MPV) in a live porcine model via the percutaneous transhepatic route. Blood samples were collected and tested before and after operation, as well as before euthanasia. Single-photon emission computed tomography (SPECT) combined with CT (SPECT/CT) scan were performed directly after operation and CT scan was performed 2 months after implantation. After the CT scan was performed, all animals were euthanized and histologically examined.

          Results

          The novel stent was successfully positioned in all six pigs. No deterioration of liver function was observed during the 2-month follow-up period. SPECT/CT revealed the uniform distribution of radiation around the seeds strand, and the hottest spot was near the center of the MPV. The patency of the stented MPV was confirmed using CT scans. The tissue-accumulated absorbed dose was 31,822.11 mGy at 10 mm transversely away from the midpoint of the 125I seeds strand, with a half-life of 59.4 days. Pathological examination results showed no significant atrophy or inflammation of adjunct liver tissue, and no obvious intima thickening or thrombosis were detected in the stented MPV.

          Conclusions

          A liver porcine model was used to demonstrate that the transhepatic placement of a novel endovascular brachytherapy stent, EVB-Stent, is both technically feasible and safe.

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          Most cited references32

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          Global Cancer Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries

          Ahmedin Jemal, Lindsey A Torre, Rebecca Siegel … (2018)
          This article provides a status report on the global burden of cancer worldwide using the GLOBOCAN 2018 estimates of cancer incidence and mortality produced by the International Agency for Research on Cancer, with a focus on geographic variability across 20 world regions. There will be an estimated 18.1 million new cancer cases (17.0 million excluding nonmelanoma skin cancer) and 9.6 million cancer deaths (9.5 million excluding nonmelanoma skin cancer) in 2018. In both sexes combined, lung cancer is the most commonly diagnosed cancer (11.6% of the total cases) and the leading cause of cancer death (18.4% of the total cancer deaths), closely followed by female breast cancer (11.6%), prostate cancer (7.1%), and colorectal cancer (6.1%) for incidence and colorectal cancer (9.2%), stomach cancer (8.2%), and liver cancer (8.2%) for mortality. Lung cancer is the most frequent cancer and the leading cause of cancer death among males, followed by prostate and colorectal cancer (for incidence) and liver and stomach cancer (for mortality). Among females, breast cancer is the most commonly diagnosed cancer and the leading cause of cancer death, followed by colorectal and lung cancer (for incidence), and vice versa (for mortality); cervical cancer ranks fourth for both incidence and mortality. The most frequently diagnosed cancer and the leading cause of cancer death, however, substantially vary across countries and within each country depending on the degree of economic development and associated social and life style factors. It is noteworthy that high-quality cancer registry data, the basis for planning and implementing evidence-based cancer control programs, are not available in most low- and middle-income countries. The Global Initiative for Cancer Registry Development is an international partnership that supports better estimation, as well as the collection and use of local data, to prioritize and evaluate national cancer control efforts. CA: A Cancer Journal for Clinicians 2018;0:1-31. © 2018 American Cancer Society.
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            Sorafenib in advanced hepatocellular carcinoma.

            Josep Llovet, Sergio Ricci, Vincenzo Mazzaferro … (2008)
            No effective systemic therapy exists for patients with advanced hepatocellular carcinoma. A preliminary study suggested that sorafenib, an oral multikinase inhibitor of the vascular endothelial growth factor receptor, the platelet-derived growth factor receptor, and Raf may be effective in hepatocellular carcinoma. In this multicenter, phase 3, double-blind, placebo-controlled trial, we randomly assigned 602 patients with advanced hepatocellular carcinoma who had not received previous systemic treatment to receive either sorafenib (at a dose of 400 mg twice daily) or placebo. Primary outcomes were overall survival and the time to symptomatic progression. Secondary outcomes included the time to radiologic progression and safety. At the second planned interim analysis, 321 deaths had occurred, and the study was stopped. Median overall survival was 10.7 months in the sorafenib group and 7.9 months in the placebo group (hazard ratio in the sorafenib group, 0.69; 95% confidence interval, 0.55 to 0.87; P<0.001). There was no significant difference between the two groups in the median time to symptomatic progression (4.1 months vs. 4.9 months, respectively, P=0.77). The median time to radiologic progression was 5.5 months in the sorafenib group and 2.8 months in the placebo group (P<0.001). Seven patients in the sorafenib group (2%) and two patients in the placebo group (1%) had a partial response; no patients had a complete response. Diarrhea, weight loss, hand-foot skin reaction, and hypophosphatemia were more frequent in the sorafenib group. In patients with advanced hepatocellular carcinoma, median survival and the time to radiologic progression were nearly 3 months longer for patients treated with sorafenib than for those given placebo. (ClinicalTrials.gov number, NCT00105443.) 2008 Massachusetts Medical Society
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              Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomised, double-blind, placebo-controlled trial.

              Ann-Lii Cheng, Yoon-Koo Kang, Zhendong Chen … (2009)
              Most cases of hepatocellular carcinoma occur in the Asia-Pacific region, where chronic hepatitis B infection is an important aetiological factor. Assessing the efficacy and safety of new therapeutic options in an Asia-Pacific population is thus important. We did a multinational phase III, randomised, double-blind, placebo-controlled trial to assess the efficacy and safety of sorafenib in patients from the Asia-Pacific region with advanced (unresectable or metastatic) hepatocellular carcinoma. Between Sept 20, 2005, and Jan 31, 2007, patients with hepatocellular carcinoma who had not received previous systemic therapy and had Child-Pugh liver function class A, were randomly assigned to receive either oral sorafenib (400 mg) or placebo twice daily in 6-week cycles, with efficacy measured at the end of each 6-week period. Eligible patients were stratified by the presence or absence of macroscopic vascular invasion or extrahepatic spread (or both), Eastern Cooperative Oncology Group performance status, and geographical region. Randomisation was done centrally and in a 2:1 ratio by means of an interactive voice-response system. There was no predefined primary endpoint; overall survival, time to progression (TTP), time to symptomatic progression (TTSP), disease control rate (DCR), and safety were assessed. Efficacy analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00492752. 271 patients from 23 centres in China, South Korea, and Taiwan were enrolled in the study. Of these, 226 patients were randomly assigned to the experimental group (n=150) or to the placebo group (n=76). Median overall survival was 6.5 months (95% CI 5.56-7.56) in patients treated with sorafenib, compared with 4.2 months (3.75-5.46) in those who received placebo (hazard ratio [HR] 0.68 [95% CI 0.50-0.93]; p=0.014). Median TTP was 2.8 months (2.63-3.58) in the sorafenib group compared with 1.4 months (1.35-1.55) in the placebo group (HR 0.57 [0.42-0.79]; p=0.0005). The most frequently reported grade 3/4 drug-related adverse events in the 149 assessable patients treated with sorafenib were hand-foot skin reaction (HFSR; 16 patients [10.7%]), diarrhoea (nine patients [6.0%]), and fatigue (five patients [3.4%]). The most common adverse events resulting in dose reductions were HFSR (17 patients [11.4%]) and diarrhoea (11 patients [7.4%]); these adverse events rarely led to discontinuation. Sorafenib is effective for the treatment of advanced hepatocellular carcinoma in patients from the Asia-Pacific region, and is well tolerated. Taken together with data from the Sorafenib Hepatocellular Carcinoma Assessment Randomised Protocol (SHARP) trial, sorafenib seems to be an appropriate option for the treatment of advanced hepatocellular carcinoma.
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                Author and article information

                Journal
                Journal ID (nlm-ta): J Clin Transl Hepatol
                Journal ID (iso-abbrev): J Clin Transl Hepatol
                Journal ID (publisher-id): JCTH
                Title: Journal of Clinical and Translational Hepatology
                Publisher: XIA & HE Publishing Inc.
                ISSN (Print): 2225-0719
                ISSN (Electronic): 2310-8819
                Publication date (Print): 28 October 2021
                Publication date (Electronic): 7 July 2021
                Volume: 9
                Issue: 5
                Pages: 711-718
                Affiliations
                [1 ]Department of Interventional Radiology, Zhongshan Hospital, Fudan University, Shanghai, China
                [2 ]Shanghai Institution of Medical Imaging, Shanghai, China
                Author notes
                [* ] Correspondence to: Zhiping Yan and Jianjun Luo, Department of Interventional Radiology, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Shanghai 200032, China. ORCID: https://orcid.org/0000-0001-7907-435X (ZY), https://orcid.org/0000-0003-4942-0439 (JL). Tel: +86-13681971205, E-mail: yan.zhiping@ 123456zs-hospital.sh.cn (ZY); Tel: +86-13801924777, E-mail: luo.jianjun@ 123456zs-hospital.sh.cn (JL)
                [#]

                These two authors contributed equally to this study.

                This study has received funding by the Shanghai Science Committee (16411968600), Clinical Research Special Fund from Zhongshan Hospital, Fudan University (2013SY060) and National Clinical Research Center for International Medicine.

                The authors have no conflict of interests related to this publication.

                Study concept and design (JL, ZY), acquisition of data (ND, JM, YZ), analysis and interpretation of data (MY, WZ, ZZ), obtained funding (ZY), drafting of the manuscript (ND, JM), critical revision of the manuscript for important intellectual content (MY, WZ), administrative, technical, or material support, study supervision (JL).

                Author information
                https://orcid.org/0000-0001-8881-2625
                https://orcid.org/0000-0002-8755-3411
                https://orcid.org/0000-0003-0957-9701
                https://orcid.org/0000-0001-9578-3922
                https://orcid.org/0000-0002-6491-1300
                https://orcid.org/0000-0002-2301-147X
                https://orcid.org/0000-0003-4942-0439
                https://orcid.org/0000-0001-7907-435X
                Article
                Publisher ID: JCTH.2020.00128
                DOI: 10.14218/JCTH.2020.00128
                PMC ID: 8516836
                SO-VID: d0744657-3221-41d9-b9ed-1e62f557e91b
                Copyright © © 2021 Authors.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-Noncommercial 4.0 International License (CC BY-NC 4.0), permitting all non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 24 November 2020
                Date revision received : 20 March 2021
                Date accepted : 7 April 2021
                Categories
                Subject: Original Article

                Keywords: portal vein tumor,tumor thrombus,brachytherapy,stent,iodine-125 seeds strand
                Data availability:
                Keywords: portal vein tumor, tumor thrombus, brachytherapy, stent, iodine-125 seeds strand

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