The Efficacy And Safety Study Of A New Submucosal Injection(EndoClot~?SIS Polysaccharide Injection) In The ESD Operation

Objective:Endoscopic submucosal dissection(ESD)is the preferred treatment for early cancers of the digestive tract.ESD has a series of complications,including digestive tract perforation and bleeding.In order to reduce the incidence of complications,submucosal injection has been widely used in ESD.The existing injections are not effective due to some problems,therefore,this research intends to use a new type of submucosal injection-EndoClot(?)SIS polysaccharide injection,compared with traditional submucosal injection research,to evaluate its efficacy and safety in ESD and provide the basis for further clinical application.Materials and methods:In vitro study:4 excised pig stomachs were used.1ml of each solution(EndoClot(?)SIS polysaccharide injection,EleviewTM injection and sigMAViscTM injection,0.95%NaCl)was injected to submucosa of the stomach to observe the submucous uplift effect and the maintain time;histopathological sections were taken to observe the separation of mucosa and muscularis propria.In vivo study:18 experimental pigs were used,they were randomly divided into three groups(each n=6),(EleviewTM injection group,the sigMAViscTM injection group and the EndoClot(?)SIS polysaccharide injection group).3ml of each solution was injected into the submucosa of the esophagus to observe the submucosal uplift effect and the maintain time.Then gastric ESD was performed and the operation time and complications were recorded.Results:1.Submucosal elevation test in vitro studyThe height of mucosal uplift was measured by ultrasonic probe within 60 minutes.The 0 minute heights of mucosal uplift after injected by EleviewTM injection,sigMAVisc TM injection,0.9%NaCl and EndoClot(?)SIS polysaccharide injection were 0.524±0.026mm,0.495±0.128mm,0.269±0.045,0.673±0.049mm.The lifting height of the(normal)saline group after 20 minutes basically disappeared.After 60 minutes,the retention rates by injection of EndoClot(?)SIS polysaccharide injection,the EleviewTM injection,the sigMAViscTM injection were 81%,72%and 55%.For the EndoClot(?)SIS polysaccharide injection group,the mucosal lifting height was always greater than other two groups,and the downtrend of the mucosal lifting height was slower.The difference of retention rate at each time point was statistically significant(P<0.05).2.Submucosal elevation test in vivo studyThe height of esophageal submucosal uplift was measured by a nini probe ultrasonography.The uplift boundary was legible in the EndoClot(?)SIS polysaccharide injection group.The uplift height and maintaining time of the EndoClot(?)SIS polysaccharide injection group were significantly better than Eleview-rM injection group and the sigMAViscTM injection group,the difference of retention rate at each time point was statistically significant(P<0.05).3.The ESD test3.1 Comparison of operation time in ESD.The operation time of the stomach ESD among the three groups(EleviewTM injection group,sigMAViscTM injection group,EndoClot(?)SIS polysaccharide injection group was 47.3±19.4min,38.7±21.2min,and 37.7±17.2min,respectively.There was no significant difference in operation time among the three groups(P>0.05).3.2 Comparison of injection volume in ESD.The injection volume of the stomach ESD among the three groups(Eleview TM injection group,sigMAViscTM injection group,EndoClot(?)SIS polysaccharide injection group was 32.3±17.5ml,32.8±8.9ml,23.5±7.lml,respectively.There was no significant difference in the injection volume among the three groups(P>0.05).3.3 Observation of ESD complicationsThere was no perforation in all ESD cases,all operations were completed successfully.The bleeding was more in the EleviewTM injection group,compared with the other groups.3.4.Hb content changes before and after operationThere was no significant difference between the preoperative Hb content and that measured one week/two weeks after operation(P>0.05).3.5 Histopathological changesIn vitro experiments the mucosa and muscularis propria were well separated after injection of the EndoClot(?)SIS polysaccharide injection.In vivo experiments,there were no changes in tissue structure,at the injection site of esophageal mucosa.1 week and 2 weeks after the operation,no injection residue was found in the artificial ulcer,and large amounts of inflammatory cell infiltration and fibrous proliferation were observed.No tissue necrosis was observed.Conclusion:Compared with the traditional submucosal injections,EndoClot(?)SIS polysaccharide injection can obtain better submucosal lift,longer maintain time.EndoClot(?)SIS polysaccharide injection is helpful to reduce the complications such as perforation and bleeding,and improve the safety of ESD.EndoClot(?)SIS polysaccharide injection is safe and effective.