Application of indocyanine green-human serum albumin complex in fluorescence image-guided laparoscopic anatomical liver resection: study protocol for a randomized controlled trial
Indocyanine green (ICG) is a near-infrared fluorescent dye widely used for intraoperative navigation during liver surgeries because of its non-radioactive nature, high safety, and minimal impact on liver function. However, variability in its dosage and concentration and its low imaging success rates...
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| Veröffentlicht in: | Current controlled trials in cardiovascular medicine 2024-12, Vol.25 (1), p.847-13 |
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| creator | Xie, Qingyun Gao, Fengwei Ran, Xiaoyun Zhao, Xin Yang, Manyu Jiang, Kangyi Mao, Tianyang Yang, Jiayin Li, Kun Wu, Hong |
| description | Indocyanine green (ICG) is a near-infrared fluorescent dye widely used for intraoperative navigation during liver surgeries because of its non-radioactive nature, high safety, and minimal impact on liver function. However, variability in its dosage and concentration and its low imaging success rates have limited its widespread application. To address these issues, we developed a novel ICG-human serum albumin (ICG-HSA) complex to enhance fluorescence visualization during laparoscopic anatomical liver resection.
This prospective, double-blind, single-center, randomized controlled trial will compare the fluorescence navigation effects of the novel ICG-HSA complex with the guideline-recommended ICG administration scheme. The study will involve patients aged 18 to 75 years with malignant liver tumors. The participants will undergo evaluations at specified time points, and data will be collected using an internet-based electronic data capture system. The primary outcome will be the effectiveness of intraoperative fluorescence imaging, assessed by three independent experts. The secondary outcomes will be conversion to open surgery, the total operative time, intraoperative blood loss, and long-term survival rates.
The aim of using this novel ICG-HSA complex will be to improve the success rate of fluorescence navigation in liver resection by ensuring better stability and a longer liver retention time compared with free ICG. This study seeks to validate the clinical value of ICG-HSA in enhancing surgical precision and outcomes, ultimately promoting its broader clinical application. The results are expected to provide high-level evidence supporting the safety and efficacy of this new fluorescence imaging agent.
ClinicalTrial.gov NCT06219096. Registered on 1 December 2024. |
| doi_str_mv | 10.1186/s13063-024-08695-5 |
| format | Article |
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This prospective, double-blind, single-center, randomized controlled trial will compare the fluorescence navigation effects of the novel ICG-HSA complex with the guideline-recommended ICG administration scheme. The study will involve patients aged 18 to 75 years with malignant liver tumors. The participants will undergo evaluations at specified time points, and data will be collected using an internet-based electronic data capture system. The primary outcome will be the effectiveness of intraoperative fluorescence imaging, assessed by three independent experts. The secondary outcomes will be conversion to open surgery, the total operative time, intraoperative blood loss, and long-term survival rates.
The aim of using this novel ICG-HSA complex will be to improve the success rate of fluorescence navigation in liver resection by ensuring better stability and a longer liver retention time compared with free ICG. This study seeks to validate the clinical value of ICG-HSA in enhancing surgical precision and outcomes, ultimately promoting its broader clinical application. The results are expected to provide high-level evidence supporting the safety and efficacy of this new fluorescence imaging agent.
ClinicalTrial.gov NCT06219096. Registered on 1 December 2024.</description><identifier>ISSN: 1745-6215</identifier><identifier>EISSN: 1745-6215</identifier><identifier>DOI: 10.1186/s13063-024-08695-5</identifier><identifier>PMID: 39710697</identifier><language>eng</language><publisher>England: BioMed Central Ltd</publisher><subject>Adolescent ; Adult ; Aged ; Albumin ; Clinical trials ; Double-Blind Method ; Female ; Fluorescence ; Fluorescence navigation ; Fluorescent Dyes - administration & dosage ; Hepatectomy - adverse effects ; Hepatectomy - methods ; Humans ; ICG-HSA complex ; Indocyanine green ; Indocyanine Green - administration & dosage ; Laparoscopic liver resection ; Laparoscopic surgery ; Laparoscopy ; Laparoscopy - adverse effects ; Laparoscopy - methods ; Liver ; Liver - diagnostic imaging ; Liver - surgery ; Liver Neoplasms - diagnostic imaging ; Liver Neoplasms - surgery ; Male ; Medical research ; Medicine, Experimental ; Middle Aged ; Optical Imaging - methods ; Performance evaluation ; Prospective Studies ; Proteins ; Randomized controlled trial ; Randomized Controlled Trials as Topic ; Retention ; Serum Albumin, Human ; Study Protocol ; Surgery ; Surgery, Computer-Assisted - methods ; Surgical outcomes ; Time Factors ; Treatment Outcome ; Tumors ; Veins & arteries ; Visualization ; Young Adult</subject><ispartof>Current controlled trials in cardiovascular medicine, 2024-12, Vol.25 (1), p.847-13</ispartof><rights>2024. The Author(s).</rights><rights>COPYRIGHT 2024 BioMed Central Ltd.</rights><rights>Copyright BioMed Central Dec 2024</rights><rights>The Author(s) 2024 2024</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC11664937/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC11664937/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39710697$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Xie, Qingyun</creatorcontrib><creatorcontrib>Gao, Fengwei</creatorcontrib><creatorcontrib>Ran, Xiaoyun</creatorcontrib><creatorcontrib>Zhao, Xin</creatorcontrib><creatorcontrib>Yang, Manyu</creatorcontrib><creatorcontrib>Jiang, Kangyi</creatorcontrib><creatorcontrib>Mao, Tianyang</creatorcontrib><creatorcontrib>Yang, Jiayin</creatorcontrib><creatorcontrib>Li, Kun</creatorcontrib><creatorcontrib>Wu, Hong</creatorcontrib><title>Application of indocyanine green-human serum albumin complex in fluorescence image-guided laparoscopic anatomical liver resection: study protocol for a randomized controlled trial</title><title>Current controlled trials in cardiovascular medicine</title><addtitle>Trials</addtitle><description>Indocyanine green (ICG) is a near-infrared fluorescent dye widely used for intraoperative navigation during liver surgeries because of its non-radioactive nature, high safety, and minimal impact on liver function. However, variability in its dosage and concentration and its low imaging success rates have limited its widespread application. To address these issues, we developed a novel ICG-human serum albumin (ICG-HSA) complex to enhance fluorescence visualization during laparoscopic anatomical liver resection.
This prospective, double-blind, single-center, randomized controlled trial will compare the fluorescence navigation effects of the novel ICG-HSA complex with the guideline-recommended ICG administration scheme. The study will involve patients aged 18 to 75 years with malignant liver tumors. The participants will undergo evaluations at specified time points, and data will be collected using an internet-based electronic data capture system. The primary outcome will be the effectiveness of intraoperative fluorescence imaging, assessed by three independent experts. The secondary outcomes will be conversion to open surgery, the total operative time, intraoperative blood loss, and long-term survival rates.
The aim of using this novel ICG-HSA complex will be to improve the success rate of fluorescence navigation in liver resection by ensuring better stability and a longer liver retention time compared with free ICG. This study seeks to validate the clinical value of ICG-HSA in enhancing surgical precision and outcomes, ultimately promoting its broader clinical application. The results are expected to provide high-level evidence supporting the safety and efficacy of this new fluorescence imaging agent.
ClinicalTrial.gov NCT06219096. Registered on 1 December 2024.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Albumin</subject><subject>Clinical trials</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Fluorescence</subject><subject>Fluorescence navigation</subject><subject>Fluorescent Dyes - administration & dosage</subject><subject>Hepatectomy - adverse effects</subject><subject>Hepatectomy - methods</subject><subject>Humans</subject><subject>ICG-HSA complex</subject><subject>Indocyanine green</subject><subject>Indocyanine Green - administration & dosage</subject><subject>Laparoscopic liver resection</subject><subject>Laparoscopic surgery</subject><subject>Laparoscopy</subject><subject>Laparoscopy - adverse effects</subject><subject>Laparoscopy - methods</subject><subject>Liver</subject><subject>Liver - diagnostic imaging</subject><subject>Liver - surgery</subject><subject>Liver Neoplasms - diagnostic imaging</subject><subject>Liver Neoplasms - surgery</subject><subject>Male</subject><subject>Medical research</subject><subject>Medicine, Experimental</subject><subject>Middle Aged</subject><subject>Optical Imaging - methods</subject><subject>Performance evaluation</subject><subject>Prospective Studies</subject><subject>Proteins</subject><subject>Randomized controlled trial</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Retention</subject><subject>Serum Albumin, Human</subject><subject>Study Protocol</subject><subject>Surgery</subject><subject>Surgery, Computer-Assisted - methods</subject><subject>Surgical outcomes</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><subject>Veins & arteries</subject><subject>Visualization</subject><subject>Young Adult</subject><issn>1745-6215</issn><issn>1745-6215</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>DOA</sourceid><recordid>eNptkstu1TAQhiMEoqXwAiyQJTZsUnyLnbBBRxWXSpXYwDqa2ONTV44dnKTq4bV4QXzaUvUgZMke2f9843_sqnrN6CljrXo_M0GVqCmXNW1V19TNk-qYadnUirPm6aP4qHoxz1eUStEJ-bw6Ep1mVHX6uPq9mabgDSw-RZIc8dEms4PoI5JtRoz15TpCJDPmdSQQhnX0kZg0TgFvipq4sKaMs8FokPgRtlhvV2_RkgAT5DSbNHlDIMKSxlIokOCvMZOSg2Zf9QOZl9XuyJTTkkwKxKVMgGQoNxn9rwIyKS45hVDCJXsIL6tnDsKMr-7Xk-rH50_fz77WF9--nJ9tLmrLtdC1pIJzwbUdwDk9DJK3gNR0xmhtTUfBts1gjNWmzAaclkp1rOXasdYZ5OKkOr_j2gRX_ZSLu7zrE_j-diPlbQ958SZgz5VoAVzDqbBSSD0oBk1rwdiBIjpWWB_vWNM6jGhLu5YM4QB6eBL9Zb9N1z1jSslO6EJ4d0_I6eeK89KPvrQ9BIiY1rkXTLayUw1vi_TtP9KrtOZYenWroorKgnxQbaE48NGlUtjsof2m5YzKfeWiOv2PqgyL5TlTROfL_kHCm8dOHyz-_XPiDzL43n4</recordid><startdate>20241223</startdate><enddate>20241223</enddate><creator>Xie, Qingyun</creator><creator>Gao, Fengwei</creator><creator>Ran, Xiaoyun</creator><creator>Zhao, Xin</creator><creator>Yang, Manyu</creator><creator>Jiang, Kangyi</creator><creator>Mao, Tianyang</creator><creator>Yang, Jiayin</creator><creator>Li, Kun</creator><creator>Wu, Hong</creator><general>BioMed Central Ltd</general><general>BioMed Central</general><general>BMC</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20241223</creationdate><title>Application of indocyanine green-human serum albumin complex in fluorescence image-guided laparoscopic anatomical liver resection: study protocol for a randomized controlled trial</title><author>Xie, Qingyun ; Gao, Fengwei ; Ran, Xiaoyun ; Zhao, Xin ; Yang, Manyu ; Jiang, Kangyi ; Mao, Tianyang ; Yang, Jiayin ; Li, Kun ; Wu, Hong</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-d2737-40322327dbaff7bb428ae0c9cc77dc90ad85bccd7cbcccaf746691827f18fce23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Albumin</topic><topic>Clinical trials</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Fluorescence</topic><topic>Fluorescence navigation</topic><topic>Fluorescent Dyes - administration & dosage</topic><topic>Hepatectomy - adverse effects</topic><topic>Hepatectomy - methods</topic><topic>Humans</topic><topic>ICG-HSA complex</topic><topic>Indocyanine green</topic><topic>Indocyanine Green - administration & dosage</topic><topic>Laparoscopic liver resection</topic><topic>Laparoscopic surgery</topic><topic>Laparoscopy</topic><topic>Laparoscopy - adverse effects</topic><topic>Laparoscopy - methods</topic><topic>Liver</topic><topic>Liver - diagnostic imaging</topic><topic>Liver - surgery</topic><topic>Liver Neoplasms - diagnostic imaging</topic><topic>Liver Neoplasms - surgery</topic><topic>Male</topic><topic>Medical research</topic><topic>Medicine, Experimental</topic><topic>Middle Aged</topic><topic>Optical Imaging - methods</topic><topic>Performance evaluation</topic><topic>Prospective Studies</topic><topic>Proteins</topic><topic>Randomized controlled trial</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Retention</topic><topic>Serum Albumin, Human</topic><topic>Study Protocol</topic><topic>Surgery</topic><topic>Surgery, Computer-Assisted - methods</topic><topic>Surgical outcomes</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><topic>Veins & arteries</topic><topic>Visualization</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Xie, Qingyun</creatorcontrib><creatorcontrib>Gao, Fengwei</creatorcontrib><creatorcontrib>Ran, Xiaoyun</creatorcontrib><creatorcontrib>Zhao, Xin</creatorcontrib><creatorcontrib>Yang, Manyu</creatorcontrib><creatorcontrib>Jiang, Kangyi</creatorcontrib><creatorcontrib>Mao, Tianyang</creatorcontrib><creatorcontrib>Yang, Jiayin</creatorcontrib><creatorcontrib>Li, Kun</creatorcontrib><creatorcontrib>Wu, Hong</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>Current controlled trials in cardiovascular medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Xie, Qingyun</au><au>Gao, Fengwei</au><au>Ran, Xiaoyun</au><au>Zhao, Xin</au><au>Yang, Manyu</au><au>Jiang, Kangyi</au><au>Mao, Tianyang</au><au>Yang, Jiayin</au><au>Li, Kun</au><au>Wu, Hong</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Application of indocyanine green-human serum albumin complex in fluorescence image-guided laparoscopic anatomical liver resection: study protocol for a randomized controlled trial</atitle><jtitle>Current controlled trials in cardiovascular medicine</jtitle><addtitle>Trials</addtitle><date>2024-12-23</date><risdate>2024</risdate><volume>25</volume><issue>1</issue><spage>847</spage><epage>13</epage><pages>847-13</pages><issn>1745-6215</issn><eissn>1745-6215</eissn><abstract>Indocyanine green (ICG) is a near-infrared fluorescent dye widely used for intraoperative navigation during liver surgeries because of its non-radioactive nature, high safety, and minimal impact on liver function. However, variability in its dosage and concentration and its low imaging success rates have limited its widespread application. To address these issues, we developed a novel ICG-human serum albumin (ICG-HSA) complex to enhance fluorescence visualization during laparoscopic anatomical liver resection.
This prospective, double-blind, single-center, randomized controlled trial will compare the fluorescence navigation effects of the novel ICG-HSA complex with the guideline-recommended ICG administration scheme. The study will involve patients aged 18 to 75 years with malignant liver tumors. The participants will undergo evaluations at specified time points, and data will be collected using an internet-based electronic data capture system. The primary outcome will be the effectiveness of intraoperative fluorescence imaging, assessed by three independent experts. The secondary outcomes will be conversion to open surgery, the total operative time, intraoperative blood loss, and long-term survival rates.
The aim of using this novel ICG-HSA complex will be to improve the success rate of fluorescence navigation in liver resection by ensuring better stability and a longer liver retention time compared with free ICG. This study seeks to validate the clinical value of ICG-HSA in enhancing surgical precision and outcomes, ultimately promoting its broader clinical application. The results are expected to provide high-level evidence supporting the safety and efficacy of this new fluorescence imaging agent.
ClinicalTrial.gov NCT06219096. Registered on 1 December 2024.</abstract><cop>England</cop><pub>BioMed Central Ltd</pub><pmid>39710697</pmid><doi>10.1186/s13063-024-08695-5</doi><tpages>13</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adolescent Adult Aged Albumin Clinical trials Double-Blind Method Female Fluorescence Fluorescence navigation Fluorescent Dyes - administration & dosage Hepatectomy - adverse effects Hepatectomy - methods Humans ICG-HSA complex Indocyanine green Indocyanine Green - administration & dosage Laparoscopic liver resection Laparoscopic surgery Laparoscopy Laparoscopy - adverse effects Laparoscopy - methods Liver Liver - diagnostic imaging Liver - surgery Liver Neoplasms - diagnostic imaging Liver Neoplasms - surgery Male Medical research Medicine, Experimental Middle Aged Optical Imaging - methods Performance evaluation Prospective Studies Proteins Randomized controlled trial Randomized Controlled Trials as Topic Retention Serum Albumin, Human Study Protocol Surgery Surgery, Computer-Assisted - methods Surgical outcomes Time Factors Treatment Outcome Tumors Veins & arteries Visualization Young Adult |
| title | Application of indocyanine green-human serum albumin complex in fluorescence image-guided laparoscopic anatomical liver resection: study protocol for a randomized controlled trial |
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