[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566245":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":54,"collaborators":17,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":17,"enrollmentInfo":67,"targetDuration":17,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":87,"overallStatus":41,"whyStopped":17,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Meander Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Organ-sparing surgery","EXPERIMENTAL","Local resection with sentinel lymph node biopsy",[13],"Procedure: Organ-sparing surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care segmental resection","ACTIVE_COMPARATOR",null,[19],"Procedure: Standard of care segmental resection",[21,25],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":17},"PROCEDURE","Endoscopy-assisted laparoscopic\u002Frobotic wedge resection and sentinel lymph node biopsy using submucosal injection of ICG.",[9],{"type":22,"name":15,"description":26,"armGroupLabels":27,"otherNames":17},"Standard of care segmental resection of the affected part of the colon including removal of regional lymph nodes.",[15],[29],{"name":30,"affiliation":5,"role":31},"Frank J Voskens","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":17,"email":37},"Bart CT van de Laar","CONTACT","+31338507137","bct.vande.laar@meandermc.nl",[39],{"facility":40,"status":41,"city":42,"state":17,"zip":17,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Meander Medisch Centrum","RECRUITING","Amersfoort","Netherlands","NL",{"type":46,"coordinates":47},"Point",[48,49],5.3875,52.155,{"lat":49,"lon":48},[52],{"name":53,"role":35,"phone":36,"phoneExt":17,"email":37},"Bart CT van de Laar, MD",{"type":31,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Esther Consten","Prof. dr. Esther Consten","100566245","sentinel-node-and-organ-sparing-surgery-in-stage-i-colon-carcinoma-100566245",false,"NCT06652672","Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma","Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma (SENTRY Trial)","SENTRY","Inclusion Criteria:\n\n* Oral and written informed consent (IC)\n* Aged 18 years and older\n* Fit for both organ-sparing surgery and colectomy\n* Pathologically confirmed T1-2 adenocarcinoma of the colon following R0, R1, or Rx endoscopic resection with an estimated LNM risk \\>15% (Table 5.2.2. in module 5.2 of the Dutch CRC guideline); or a lesion macroscopically suspected to be (deep-invasive) T1 colon cancer, measuring \\\u003C40 mm, for which wedge resection is considered the most suitable local resection technique as recommended by the MDT\n* The resection scar after local excision is expected to be clearly recognized at endoscopy, either by a tattoo or by detecting a scar in the colorectal segment where no other polypectomies were performed\n* Lesion located \\>25cm from the anus based on endoscopic measurement, or above sigmoid take-off\n\nExclusion Criteria:\n\n* Patients who opt for active follow-up instead of surgery following shared decision-making\n* Distant metastasis\n* Lynch syndrome\n* Another active malignancy requiring palliative treatment at the time of colon cancer diagnosis\n* Previous colorectal cancer within the last 5 years\n* Tumours that comprised \\>50% of the colon circumference before resection\n* Tumours involving the ileocaecal valve\n* Pregnancy, lactation or a planned pregnancy during the course of the study\n* Known allergy to any of the compounds used for SLN identification (ICG, Iodine or Sodium iodide)\n* Previous colonic surgery (excluding appendectomy)\n* Contra-indication for laparoscopic or robotic surgery\n* Severe kidney- or liver failure\n* Hyperthyroidism or an autonomously functioning thyroid adenoma","ALL","18 Years",{"count":68,"type":69},341,"ESTIMATED","INTERVENTIONAL",[72],"NA","The aim of this study is to reduce the need for colectomy and its' associated morbidity and mortality in patients with pT1-2 colon carcinoma after endoscopic resection and an estimated lymph node metastasis (LNM) risk of \\>15%, or with macroscopically suspected T1 tumors, by performing an endoscopic-assisted laparoscopic\u002Frobotic wedge resection of the tumor or scar, along with sentinel node (SLN) biopsy using indocyanine green (ICG). This intervention will be compared to the standard-of-care segmental resection using a partially randomized patient preference design. The primary outcome is the 3-year recurrence rate.",[75,76,77,78,79,80,81,82,83,84,85,86],"Colon Cancer","Colon Adenocarcinoma","Sentinel Lymph Node","Sentinel Lymph Node Biopsy","Colon Neoplasms","Colon Neoplasm","Fluorescence","Fluorescence Guided Surgery","Fluorescence Laparoscopy","Fluorescence-guided Resection","Colon Surgery","Indocyanine Green (ICG)",[88,81,89,90,91,92,93],"Colon cancer","Sentinel lymph node","Indocyanine green (ICG)","Organ sparing surgery","Organ preserving surgery","Local resection","2025-11-17",{"date":96,"type":97},"2025-11-20","ACTUAL",{"date":99,"type":97},"2024-12-12",{"date":101,"type":69},"2032-12-12",{"name":5,"class":6},1]