[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100363145":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":31,"centralContacts":32,"locations":38,"responsibleParty":58,"collaborators":31,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":31,"enrollmentInfo":72,"targetDuration":31,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":31,"overallStatus":41,"whyStopped":31,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Western Sydney Local Health District","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ESD","ACTIVE_COMPARATOR","Lesion with overt stigmata of SMIC or those with high risk (=\\> 10%) for covert SMIC.",[13],"Procedure: Endoscopic Submucosal Dissection",{"label":15,"type":10,"description":16,"interventionNames":17},"EMR","Lesion with no overt or a low risk for (\\\u003C10%) for covert SMIC",[18],"Procedure: Endoscopic Mucosal Resection",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Endoscopic Submucosal Dissection","Endoscopic Submucosal Dissection (ESD) results in en-bloc resection of LSL, regardless of lesion size. This allows for accurate histopathological assessment of SMIC, R0\u002FR1 resection and depth of invasion. ESD is considered a potentially curative for superficial cancers (T1a).",[9],[9],{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Endoscopic Mucosal Resection","EMR is the current standard for treating colonic LSL and has been validated to be safe and efficacious. LSLs =\\> 20mm are frequently resected piecemeal. Recent research show that resection margin soft coagulation reduces recurrence rates to those similar to en-bloc resections.",[15],[15],null,[33],{"name":34,"role":35,"phone":36,"phoneExt":31,"email":37},"Michael J Bourke, MBBS","CONTACT","+61288905555","endoscopyresearch.westmead@gmail.com",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Westmead Endoscopy Unit","RECRUITING","Westmead","New South Wales","2145","Australia","AU",{"type":48,"coordinates":49},"Point",[50,51],150.98768,-33.80383,{"lat":51,"lon":50},[54],{"name":55,"role":35,"phone":56,"phoneExt":31,"email":57},"Clarence Kerrison, MBBS","88905555","clarence.kerrison@health.nsw.gov.au",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Professor Michael Bourke","Director of Endoscopy","100363145","esd-for-colorectal-lsl-using-a-selective-strategy---a-prospective-cohort-study-100363145",false,"NCT04008407","ESD for Colorectal LSL Using a Selective Strategy - a Prospective Cohort Study","Endoscopic Submucosal Dissection for Sessile Polyps and Laterally Spreading Lesions of the Colorectum Using a Selective Strategy - a Prospective Cohort Study","COVERT","Inclusion Criteria:\n\n* All patients referred for colorectal resection of large laterally spreading lesions in colon.\n* Can give informed consent to trial participation\n\nExclusion Criteria:\n\n* Previous resection or attempted resection of target adenoma lesion\n* Endoscopic appearance of invasive malignancy\n* Age less than 18 years\n* Pregnancy\n* Active Inflammatory colonic conditions (e.g. inflammatory bowel disease)\n* Use of anticoagulant or antiplatelet agents other than aspirin outside of internationally recognised guidelines\n* American Society of Anesthesiology (ASA) Grade IV-V","ALL","18 Years",{"count":73,"type":74},391,"ESTIMATED","INTERVENTIONAL",[77],"NA","Colonic Laterally spreading lesions (LSL) =\\> 20mm are at high risk to progress to cancer. Overt stigmata of submucosal invasive cancer (SMIC) has been well characterized and includes ulceration and surface pit pattern changes as per the Kudo classification of type V.\n\nIn a recent report, risk factors for LSL with SMIC and no overt stigmata (i.e. covert SMIC) were described. Resection of these lesions 'en-bloc' can allow for better histological staging and potentially reduce the need for surgical resection.",[80,27],"Colorectal Neoplasm","2025-03-25",{"date":83,"type":84},"2025-03-27","ACTUAL",{"date":86,"type":84},"2017-08-14",{"date":88,"type":74},"2028-02",{"name":5,"class":6},1]