Efficacy An Safety Of Sodium Carboxymethyl Starch Solution As Endoscopic Submucosal Injection Solution

Aim:Submucosal injection is usually required to improve the efficacy and safety of endoscopic mucosal therapy.Up to now,the best submucosal injection solution has not been determined.This study aimed to evaluate efficacy and safety of 3.3%sodium carboxymethyl starch(Endoclot(?)SIS),a novel submucosal injection solution,for endoscopic submuosal dissection(ESD).Materials and Methods:This experiment consists of three parts.In the first part,biosafety evaluation,including examinations of in vitro cytotoxicity,in vitro hemolysis,intracutaneous reactivity,acute systemic toxicity,subacute systemic toxicity,genetic toxicity,and pyrogens,was conducted according to ISO10993 biological evaluation of medical devices.In the second part,3.3%Na-CMS,normal saline(NS)solution,and two marketed agents(sigMAViscTM and EleviewTM)were initially injected into the submucosa of the esophagus in Panama pigs.The submucosal elevation was examined by endoscopic ultrasonography.In the third part,ESD procedures using 3.3%Na-CMS or EleviewTM as submucosal injections were performed at different regions of the gastrointestinal(GI)tract of Panama pigs,and the efficacy and adverse events were examined and compared between groups.Results:No significant abnormality was found in the biosafety evaluation of 3.3%Na-CMS.The submucosal elevation was significantly higher and more sustained in the 3.3%Na-CMS group than the NS group,EleviewTM,and sigMAViscTM groups.The volume required for ESD was significantly lower at the GI tract in the 3.3%Na-CMS group compared with that in the EleviewTM group.The ESD resection time was significantly shorter in the 3.3%Na-CMS group versus the EleviewTM group.The ESD in the 3.3%Na-CMS had higher en bloc resection rate and less severe hemorrhage compared to the EleviewTM group.There were no significant differences in the perforation,solution biodegradation,laboratory examination or histologic evaluation between groups.Conclusions:The findings demonstrate that 3.3%Na-CMS has good biological safety,and is an effective and safe submucosal injection solution with higher efficacy and less severe hemorrhage in porcine models.Thus,3.3%Na-CMS holds promise as preferable agent for submucosal injection in endoscopic therapy.