{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T04:11:11Z","timestamp":1792815071706,"version":"4.5.0"},"reference-count":19,"publisher":"Springer Science and Business Media LLC","issue":"9","license":[{"start":{"date-parts":[[2023,7,20]],"date-time":"2023-07-20T00:00:00Z","timestamp":1689811200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,7,20]],"date-time":"2023-07-20T00:00:00Z","timestamp":1689811200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Astellas Pharma, Inc."}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Surg Endosc"],"published-print":{"date-parts":[[2023,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Intraoperative ureteral injury, a serious complication of abdominopelvic surgeries, can be avoided through ureter visualization. Near-infrared fluorescence imaging offers real-time anatomical visualization of ureters during surgery. Pudexacianinium (ASP5354) chloride is an indocyanine green derivative under investigation for intraoperative ureter visualization during colorectal or gynecologic surgery in adult and pediatric patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this phase 2 study (NCT04238481), adults undergoing laparoscopic colorectal surgery were randomized to receive one intravenous dose of pudexacianinium 0.3\u00a0mg, 1.0\u00a0mg, or 3.0\u00a0mg. The primary endpoint was successful intraoperative ureter visualization, defined as observation of ureter fluorescence 30\u00a0min after pudexacianinium administration and at end of surgery. Safety and pharmacokinetics were also assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Participants received pudexacianinium 0.3\u00a0mg (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20093), 1.0\u00a0mg (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20096), or 3.0\u00a0mg (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20093). Most participants were female (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200910; 83.3%); median age was 54\u00a0years (range 24\u201369) and median BMI was 29.3\u00a0kg\/m\n                      <jats:sup>2<\/jats:sup>\n                      (range 18.7\u201338.1). Successful intraoperative ureter visualization occurred in 2\/3, 5\/6, and 3\/3 participants who received pudexacianinium 0.3\u00a0mg, 1.0\u00a0mg, or 3.0\u00a0mg, respectively. Median intensity values per surgeon assessment were 1 (mild) with the 0.3-mg dose, 2 (moderate) with the 1.0-mg dose, and 3 (strong) with the 3.0-mg dose. A correlation was observed between qualitative (surgeon\u2019s recognition\/identification of the ureter during surgery) and quantitative (video recordings of the surgeries after study completion) assessment of fluorescence intensity. Two participants experienced serious adverse events, none of which were drug-related toxicities. One adverse event (grade 1 proteinuria) was related to pudexacianinium. Plasma pudexacianinium concentrations were dose-dependent and the mean (\u00b1\u2009SD) percent excreted into urine during surgery was 22.3%\u2009\u00b1\u20098.0% (0.3-mg dose), 15.6%\u2009\u00b1\u200910.0% (1.0-mg dose), and 39.5%\u2009\u00b1\u200912.4% (3.0-mg\u00a0dose).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In this study, 1.0 and 3.0\u00a0mg pudexacianinium provided ureteral visualization for the duration of minimally invasive, laparoscopic colorectal procedures and was safe and well tolerated.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00464-023-10193-9","type":"journal-article","created":{"date-parts":[[2023,7,20]],"date-time":"2023-07-20T13:02:10Z","timestamp":1689858130000},"page":"7336-7347","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Pudexacianinium (ASP5354) chloride for ureter visualization in participants undergoing laparoscopic, minimally invasive colorectal surgery"],"prefix":"10.1007","volume":"37","author":[{"given":"Matthew","family":"Albert","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leticia","family":"Delgado-Herrera","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer","family":"Paruch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pauline","family":"Gerritsen-van Schieveen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoyoshi","family":"Kishimoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shin","family":"Takusagawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Na","family":"Cai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Fengler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey","family":"Raizer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,7,20]]},"reference":[{"key":"10193_CR1","doi-asserted-by":"crossref","unstructured":"Yellinek S, Krizzuk D, Nogueras JJ, Wexner SD (2018) Ureteral injury during colorectal surgery: two case reports and a literature review. 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Ms. Leticia Delgado-Herrera and Dr. Shin Takusagawa have a patent pending for pharmaceutical composition for imaging; Mr. John Fengler is an employee\/stockholder and has patents planned, issued, or pending with Stryker; Dr. Jennifer Paruch has no conflicts of interest or financial ties to disclose.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Disclosures"}}]}}