[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621120":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":23,"locations":18,"responsibleParty":29,"collaborators":31,"id":36,"slug":18,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":41,"eligibilityCriteria":42,"healthyVolunteers":37,"sex":43,"minAge":44,"maxAge":18,"enrollmentInfo":45,"targetDuration":18,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":58,"whyStopped":18,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":18},{"fullName":5,"class":6},"Sixth Affiliated Hospital, Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"RDI group","EXPERIMENTAL","Throughout the entire ESD dissection, the RDI mode is used continuously for submucosal dissection (while white-light endoscopy may be employed for observation and marking).",[13],"Other: RDI",{"label":15,"type":16,"description":17,"interventionNames":18},"WLE group","NO_INTERVENTION","The WLE group completes the entire ESD procedure using only WLE, without switching to RDI.",null,[20],{"type":6,"name":21,"description":11,"armGroupLabels":22,"otherNames":18},"RDI",[9],[24],{"name":25,"role":26,"phone":27,"phoneExt":18,"email":28},"Jia C Sun, MM","CONTACT","86-20-38379764","sunjch8@mail.sysu.edu.cn",{"type":30,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[32,34],{"name":33,"class":6},"Guangdong Provincial Hospital of Traditional Chinese Medicine",{"name":35,"class":6},"Guangdong Second Provincial General Hospital","100621120",false,"NCT07366489","Efficacy and Safety of the RDI Mode in Endoscopic Submucosal Dissection","Efficacy and Safety of the RDI Mode in Endoscopic Submucosal Dissection: a Multicenter, Randomized Controlled Study","RM-ESD","Inclusion Criteria:\n\n* Age ≥ 18 years.\n\n  * Early gastric cancer or precancerous lesions, early esophageal cancer or precancerous lesions, or early colorectal cancer\u002Fpolyps that meet ESD indications.\n\n    * ESD procedure to be performed at a participating center.\n\n      * Lesion diameter 20-60 mm. ⑤ Written informed consent provided voluntarily.\n\nExclusion Criteria:\n\n① Foreigners.\n\n② Severe coagulopathy (platelet count \\\u003C50×10⁹\u002FL or INR \\>1.5), significant cardiopulmonary disease, or any other contraindication to endoscopic therapy.\n\n③ Imaging evidence of distant metastasis or lymph-node metastasis.","ALL","18 Years",{"count":46,"type":47},158,"ESTIMATED","INTERVENTIONAL",[50],"NA","Conventional white-light endoscopy (WLE) is hampered by insufficient contrast when attempting to identify deep vessels and active bleeding sites; visibility drops further when blood pools or spurts obscure the field, resulting in significantly lower hemostatic efficiency. Red dichromatic imaging (RDI), a novel image-enhanced endoscopic modality, has recently been shown to improve the visualization of deep-lying vessels and bleeding points, shorten hemostasis time and potentially increase overall procedural efficiency.\n\nAlthough retrospective series have suggested that RDI may facilitate intra-operative bleeding control and better delineation of the submucosal plane during endoscopic submucosal dissection (ESD), high-level evidence from multicenter, randomized, controlled trials (RCTs) is lacking. No study has yet demonstrated superiority over WLE with respect to critical endpoints such as en-bloc resection rate, procedure time, complication rate and operator mental workload.\n\nThe investigators therefore designed a multicenter RCT to systematically compare the efficacy and safety of full-procedural RDI with conventional WLE during ESD.\n\nThe primary outcome parameter is the mean resection speed (mm²\u002Fmin) achieved with RDI versus conventional white-light endoscopy during ESD.\n\nThe secondary outcome parameters are: complete resection (R0) rate, en-bloc resection rate, resection margin, number of intra-procedural bleeding episodes, intra-procedural blood loss, intra-procedural hemostasis time, other intra-procedural adverse events, and post-procedural adverse events.",[53],"Endoscopic Submucosal Dissection (ESD)",[55,21,56,57],"ESD","early cancer","polyp","NOT_YET_RECRUITING","2026-01-16",{"date":61,"type":62},"2026-01-26","ACTUAL",{"date":64,"type":47},"2026-01-01",{"date":66,"type":47},"2027-12-31",{"name":5,"class":6}]