Usefulness and safety of 0.4% sodium hyaluronate solution as a submucosal fluid “cushion” in endoscopic resection for gastric neoplasms: a prospective multicenter trial
Background Sodium hyaluronate (SH) solution has been used for submucosal injection in endoscopic resection to create a long-lasting submucosal fluid “cushion.” Objectives Our purpose was to assess the usefulness and safety of 0.4% SH solution in endoscopic resection. Design A prospective multicenter...
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| creator | Yamamoto, Hironori, MD Yahagi, Naohisa, MD Oyama, Tsuneo, MD Gotoda, Takuji, MD Doi, Toshihiko, MD Hirasaki, Shoji, MD Shimoda, Tadakazu, MD Sugano, Kentaro, MD Tajiri, Hisao, MD Takekoshi, Takao, MD Saito, Daizo, MD |
| description | Background Sodium hyaluronate (SH) solution has been used for submucosal injection in endoscopic resection to create a long-lasting submucosal fluid “cushion.” Objectives Our purpose was to assess the usefulness and safety of 0.4% SH solution in endoscopic resection. Design A prospective multicenter randomized controlled trial. Setting Six referral hospitals in Japan. Patients One hundred forty patients with 5- to 20-mm gastric intramucosal neoplastic lesions. Interventions Patients were randomized into 0.4% SH and control groups. Endoscopic resection was performed with 0.4% SH or normal saline solution for submucosal injection. Main Outcome Measurements Primary outcome measure: The usefulness of 0.4% SH solution was assessed by en bloc complete resection and the formation and maintenance of mucosal lesion-lifting during endoscopic resection. Secondary outcome measures: (1) steepness of mucosal lesion lifting, (2) complications, (3) time required for mucosal resection, (4) volume of submucosal injection solution, and (5) ease of mucosal resection. Safety was assessed by analyzing adverse events during the study period. Results The usefulness rate was significantly higher for the 0.4% SH group (88.4%, 61/69) than for the control group (58.6%, 41/70). As secondary outcome measures, significant intergroup differences ( P < .001) were noted for (1) steepness of mucosal lesion lifting, (2) volume of submucosal injection solution, and (3) ease of mucosal resection. No serious adverse events were encountered in either group. Limitations Lack of blinding. Safety was not a powered outcome measure. Conclusions Using 0.4% SH as a submucosal injection solution in endoscopic resection enabled the formation and maintenance of sufficient mucosal lesion lifting for gastric intramucosal lesions, reducing the need for additional injections and simplifying mucosal resection. Use of 0.4% SH thus simplifies the complicated procedures involved in endoscopic resection. |
| doi_str_mv | 10.1016/j.gie.2007.07.039 |
| format | Article |
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Design A prospective multicenter randomized controlled trial. Setting Six referral hospitals in Japan. Patients One hundred forty patients with 5- to 20-mm gastric intramucosal neoplastic lesions. Interventions Patients were randomized into 0.4% SH and control groups. Endoscopic resection was performed with 0.4% SH or normal saline solution for submucosal injection. Main Outcome Measurements Primary outcome measure: The usefulness of 0.4% SH solution was assessed by en bloc complete resection and the formation and maintenance of mucosal lesion-lifting during endoscopic resection. Secondary outcome measures: (1) steepness of mucosal lesion lifting, (2) complications, (3) time required for mucosal resection, (4) volume of submucosal injection solution, and (5) ease of mucosal resection. Safety was assessed by analyzing adverse events during the study period. Results The usefulness rate was significantly higher for the 0.4% SH group (88.4%, 61/69) than for the control group (58.6%, 41/70). As secondary outcome measures, significant intergroup differences ( P < .001) were noted for (1) steepness of mucosal lesion lifting, (2) volume of submucosal injection solution, and (3) ease of mucosal resection. No serious adverse events were encountered in either group. Limitations Lack of blinding. Safety was not a powered outcome measure. Conclusions Using 0.4% SH as a submucosal injection solution in endoscopic resection enabled the formation and maintenance of sufficient mucosal lesion lifting for gastric intramucosal lesions, reducing the need for additional injections and simplifying mucosal resection. Use of 0.4% SH thus simplifies the complicated procedures involved in endoscopic resection.</description><identifier>ISSN: 0016-5107</identifier><identifier>EISSN: 1097-6779</identifier><identifier>DOI: 10.1016/j.gie.2007.07.039</identifier><identifier>PMID: 18155216</identifier><identifier>CODEN: GAENBQ</identifier><language>eng</language><publisher>New York, NY: Mosby, Inc</publisher><subject>Adjuvants, Immunologic - administration & dosage ; Aged ; Biological and medical sciences ; Digestive system. Abdomen ; Endoscopy ; Endoscopy, Gastrointestinal - methods ; Female ; Follow-Up Studies ; Gastrectomy - methods ; Gastric Mucosa ; Gastroenterology and Hepatology ; Gastroenterology. Liver. Pancreas. Abdomen ; Humans ; Hyaluronic Acid - administration & dosage ; Injections, Intralesional ; Investigative techniques, diagnostic techniques (general aspects) ; Male ; Medical sciences ; Middle Aged ; Neoplasm Staging ; Prospective Studies ; Stomach Neoplasms - drug therapy ; Stomach Neoplasms - pathology ; Stomach Neoplasms - surgery ; Treatment Outcome</subject><ispartof>Gastrointestinal endoscopy, 2008-05, Vol.67 (6), p.830-839</ispartof><rights>American Society for Gastrointestinal Endoscopy</rights><rights>2008 American Society for Gastrointestinal Endoscopy</rights><rights>2008 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c502t-a32012db39e8180a08ba3133ddf825d4c38fbb9535891602e8743c9a9c47fd343</citedby><cites>FETCH-LOGICAL-c502t-a32012db39e8180a08ba3133ddf825d4c38fbb9535891602e8743c9a9c47fd343</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S001651070702439X$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20316173$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18155216$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yamamoto, Hironori, MD</creatorcontrib><creatorcontrib>Yahagi, Naohisa, MD</creatorcontrib><creatorcontrib>Oyama, Tsuneo, MD</creatorcontrib><creatorcontrib>Gotoda, Takuji, MD</creatorcontrib><creatorcontrib>Doi, Toshihiko, MD</creatorcontrib><creatorcontrib>Hirasaki, Shoji, MD</creatorcontrib><creatorcontrib>Shimoda, Tadakazu, MD</creatorcontrib><creatorcontrib>Sugano, Kentaro, MD</creatorcontrib><creatorcontrib>Tajiri, Hisao, MD</creatorcontrib><creatorcontrib>Takekoshi, Takao, MD</creatorcontrib><creatorcontrib>Saito, Daizo, MD</creatorcontrib><title>Usefulness and safety of 0.4% sodium hyaluronate solution as a submucosal fluid “cushion” in endoscopic resection for gastric neoplasms: a prospective multicenter trial</title><title>Gastrointestinal endoscopy</title><addtitle>Gastrointest Endosc</addtitle><description>Background Sodium hyaluronate (SH) solution has been used for submucosal injection in endoscopic resection to create a long-lasting submucosal fluid “cushion.” Objectives Our purpose was to assess the usefulness and safety of 0.4% SH solution in endoscopic resection. Design A prospective multicenter randomized controlled trial. Setting Six referral hospitals in Japan. Patients One hundred forty patients with 5- to 20-mm gastric intramucosal neoplastic lesions. Interventions Patients were randomized into 0.4% SH and control groups. Endoscopic resection was performed with 0.4% SH or normal saline solution for submucosal injection. Main Outcome Measurements Primary outcome measure: The usefulness of 0.4% SH solution was assessed by en bloc complete resection and the formation and maintenance of mucosal lesion-lifting during endoscopic resection. Secondary outcome measures: (1) steepness of mucosal lesion lifting, (2) complications, (3) time required for mucosal resection, (4) volume of submucosal injection solution, and (5) ease of mucosal resection. Safety was assessed by analyzing adverse events during the study period. Results The usefulness rate was significantly higher for the 0.4% SH group (88.4%, 61/69) than for the control group (58.6%, 41/70). As secondary outcome measures, significant intergroup differences ( P < .001) were noted for (1) steepness of mucosal lesion lifting, (2) volume of submucosal injection solution, and (3) ease of mucosal resection. No serious adverse events were encountered in either group. Limitations Lack of blinding. Safety was not a powered outcome measure. Conclusions Using 0.4% SH as a submucosal injection solution in endoscopic resection enabled the formation and maintenance of sufficient mucosal lesion lifting for gastric intramucosal lesions, reducing the need for additional injections and simplifying mucosal resection. Use of 0.4% SH thus simplifies the complicated procedures involved in endoscopic resection.</description><subject>Adjuvants, Immunologic - administration & dosage</subject><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Digestive system. Abdomen</subject><subject>Endoscopy</subject><subject>Endoscopy, Gastrointestinal - methods</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Gastrectomy - methods</subject><subject>Gastric Mucosa</subject><subject>Gastroenterology and Hepatology</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Humans</subject><subject>Hyaluronic Acid - administration & dosage</subject><subject>Injections, Intralesional</subject><subject>Investigative techniques, diagnostic techniques (general aspects)</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Neoplasm Staging</subject><subject>Prospective Studies</subject><subject>Stomach Neoplasms - drug therapy</subject><subject>Stomach Neoplasms - pathology</subject><subject>Stomach Neoplasms - surgery</subject><subject>Treatment Outcome</subject><issn>0016-5107</issn><issn>1097-6779</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kt1qVDEQxw-i2G31AbyR3NS7XfNxvqJQkOIXFLzQgnchm8xps-Yka-aksHd9EPsGPlWfxBx3UfBCMhAYfv-ZPzNTVc8YXTHK2peb1ZWDFae0W80h5INqwajslm3XyYfVghZo2TDaHVXHiBtKac8Fe1wdsZ41DWftovp5iTBkHwCR6GAJ6gGmHYkDoav6lGC0Lo_keqd9TjHoCUrK58nFQHRREMzrMZuI2pPBZ2fJ_e0Pk_G6APe3d8QFAsFGNHHrDEmAYH5rh5jIlcYplWyAuPUaR3xV6m1TxO0M3QAZs5-cgTBBIoXU_kn1aNAe4enhP6ku3739cv5hefHp_cfzNxdL01A-LbXglHG7FhJ61lNN-7UWTAhrh543tjaiH9Zr2Yiml6ylHPquFkZqaepusKIWJ9WLfd3i5nsGnNTo0ID3unjNqFrJ6p5zUUC2B02xjQkGtU1u1GmnGFXzitRGlRWpeUVqDiGL5vmheBkd2L-Kw04KcHoANBrth6SDcfiH41SwlnVz89d7DsoobhwkhcZBMGBdKhNUNrr_2jj7R228C640_AY7wE3MKZQZK6aQK6o-z7c0n1J5vBbyq_gFYFzIiA</recordid><startdate>20080501</startdate><enddate>20080501</enddate><creator>Yamamoto, Hironori, MD</creator><creator>Yahagi, Naohisa, MD</creator><creator>Oyama, Tsuneo, MD</creator><creator>Gotoda, Takuji, MD</creator><creator>Doi, Toshihiko, MD</creator><creator>Hirasaki, Shoji, MD</creator><creator>Shimoda, Tadakazu, MD</creator><creator>Sugano, Kentaro, MD</creator><creator>Tajiri, Hisao, MD</creator><creator>Takekoshi, Takao, MD</creator><creator>Saito, Daizo, MD</creator><general>Mosby, Inc</general><general>Elsevier</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20080501</creationdate><title>Usefulness and safety of 0.4% sodium hyaluronate solution as a submucosal fluid “cushion” in endoscopic resection for gastric neoplasms: a prospective multicenter trial</title><author>Yamamoto, Hironori, MD ; Yahagi, Naohisa, MD ; Oyama, Tsuneo, MD ; Gotoda, Takuji, MD ; Doi, Toshihiko, MD ; Hirasaki, Shoji, MD ; Shimoda, Tadakazu, MD ; Sugano, Kentaro, MD ; Tajiri, Hisao, MD ; Takekoshi, Takao, MD ; Saito, Daizo, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c502t-a32012db39e8180a08ba3133ddf825d4c38fbb9535891602e8743c9a9c47fd343</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adjuvants, Immunologic - administration & dosage</topic><topic>Aged</topic><topic>Biological and medical sciences</topic><topic>Digestive system. Abdomen</topic><topic>Endoscopy</topic><topic>Endoscopy, Gastrointestinal - methods</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Gastrectomy - methods</topic><topic>Gastric Mucosa</topic><topic>Gastroenterology and Hepatology</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Humans</topic><topic>Hyaluronic Acid - administration & dosage</topic><topic>Injections, Intralesional</topic><topic>Investigative techniques, diagnostic techniques (general aspects)</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Neoplasm Staging</topic><topic>Prospective Studies</topic><topic>Stomach Neoplasms - drug therapy</topic><topic>Stomach Neoplasms - pathology</topic><topic>Stomach Neoplasms - surgery</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yamamoto, Hironori, MD</creatorcontrib><creatorcontrib>Yahagi, Naohisa, MD</creatorcontrib><creatorcontrib>Oyama, Tsuneo, MD</creatorcontrib><creatorcontrib>Gotoda, Takuji, MD</creatorcontrib><creatorcontrib>Doi, Toshihiko, MD</creatorcontrib><creatorcontrib>Hirasaki, Shoji, MD</creatorcontrib><creatorcontrib>Shimoda, Tadakazu, MD</creatorcontrib><creatorcontrib>Sugano, Kentaro, MD</creatorcontrib><creatorcontrib>Tajiri, Hisao, MD</creatorcontrib><creatorcontrib>Takekoshi, Takao, MD</creatorcontrib><creatorcontrib>Saito, Daizo, MD</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Gastrointestinal endoscopy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yamamoto, Hironori, MD</au><au>Yahagi, Naohisa, MD</au><au>Oyama, Tsuneo, MD</au><au>Gotoda, Takuji, MD</au><au>Doi, Toshihiko, MD</au><au>Hirasaki, Shoji, MD</au><au>Shimoda, Tadakazu, MD</au><au>Sugano, Kentaro, MD</au><au>Tajiri, Hisao, MD</au><au>Takekoshi, Takao, MD</au><au>Saito, Daizo, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Usefulness and safety of 0.4% sodium hyaluronate solution as a submucosal fluid “cushion” in endoscopic resection for gastric neoplasms: a prospective multicenter trial</atitle><jtitle>Gastrointestinal endoscopy</jtitle><addtitle>Gastrointest Endosc</addtitle><date>2008-05-01</date><risdate>2008</risdate><volume>67</volume><issue>6</issue><spage>830</spage><epage>839</epage><pages>830-839</pages><issn>0016-5107</issn><eissn>1097-6779</eissn><coden>GAENBQ</coden><abstract>Background Sodium hyaluronate (SH) solution has been used for submucosal injection in endoscopic resection to create a long-lasting submucosal fluid “cushion.” Objectives Our purpose was to assess the usefulness and safety of 0.4% SH solution in endoscopic resection. Design A prospective multicenter randomized controlled trial. Setting Six referral hospitals in Japan. Patients One hundred forty patients with 5- to 20-mm gastric intramucosal neoplastic lesions. Interventions Patients were randomized into 0.4% SH and control groups. Endoscopic resection was performed with 0.4% SH or normal saline solution for submucosal injection. Main Outcome Measurements Primary outcome measure: The usefulness of 0.4% SH solution was assessed by en bloc complete resection and the formation and maintenance of mucosal lesion-lifting during endoscopic resection. Secondary outcome measures: (1) steepness of mucosal lesion lifting, (2) complications, (3) time required for mucosal resection, (4) volume of submucosal injection solution, and (5) ease of mucosal resection. Safety was assessed by analyzing adverse events during the study period. Results The usefulness rate was significantly higher for the 0.4% SH group (88.4%, 61/69) than for the control group (58.6%, 41/70). As secondary outcome measures, significant intergroup differences ( P < .001) were noted for (1) steepness of mucosal lesion lifting, (2) volume of submucosal injection solution, and (3) ease of mucosal resection. No serious adverse events were encountered in either group. Limitations Lack of blinding. Safety was not a powered outcome measure. Conclusions Using 0.4% SH as a submucosal injection solution in endoscopic resection enabled the formation and maintenance of sufficient mucosal lesion lifting for gastric intramucosal lesions, reducing the need for additional injections and simplifying mucosal resection. Use of 0.4% SH thus simplifies the complicated procedures involved in endoscopic resection.</abstract><cop>New York, NY</cop><pub>Mosby, Inc</pub><pmid>18155216</pmid><doi>10.1016/j.gie.2007.07.039</doi><tpages>10</tpages></addata></record> |
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| subjects | Adjuvants, Immunologic - administration & dosage Aged Biological and medical sciences Digestive system. Abdomen Endoscopy Endoscopy, Gastrointestinal - methods Female Follow-Up Studies Gastrectomy - methods Gastric Mucosa Gastroenterology and Hepatology Gastroenterology. Liver. Pancreas. Abdomen Humans Hyaluronic Acid - administration & dosage Injections, Intralesional Investigative techniques, diagnostic techniques (general aspects) Male Medical sciences Middle Aged Neoplasm Staging Prospective Studies Stomach Neoplasms - drug therapy Stomach Neoplasms - pathology Stomach Neoplasms - surgery Treatment Outcome |
| title | Usefulness and safety of 0.4% sodium hyaluronate solution as a submucosal fluid “cushion” in endoscopic resection for gastric neoplasms: a prospective multicenter trial |
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