[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574592":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":35,"centralContacts":45,"locations":55,"responsibleParty":73,"collaborators":35,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":35,"enrollmentInfo":86,"targetDuration":35,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":58,"whyStopped":35,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Centre Hospitalier Universitaire Saint Pierre","OTHER",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Complete clinical response","EXPERIMENTAL","Defined as the presence of residual clear scar seen on endoscopic examination, without evidence of invasive disease (\\>T2) or locoregional invasion on magnetic resonance imaging and without any signs of metastatic disease on a computerized tomography scan.",[13],"Procedure: Endoscopic resection",{"label":15,"type":10,"description":16,"interventionNames":17},"Near complete clinical response","Defined as the presence of irregular mucosa or small mucosal nodules or superficial ulceration or persisting erythema of the scar seen on endoscopic examination, without evidence of invasive disease (\\>T2) or locoregional invasion on magnetic resonance imaging and without any signs of metastatic disease on a computerized tomography scan.",[13,18,19],"Behavioral: Short interval restaging","Procedure: Total mesorectal excision",{"label":21,"type":10,"description":22,"interventionNames":23},"Incomplete response with presence of superficial residual tissue","Defined as the presence of superficial residual tissue without features of deep invasion seen on endoscopic examination, without evidence of invasive disease (\\>T2) or locoregional invasion on magnetic resonance imaging and without any signs of metastatic disease on a computerized tomography scan.",[13,18,19],{"label":25,"type":26,"description":27,"interventionNames":28},"No significant response","ACTIVE_COMPARATOR","Persistant local signs of malignancy",[19],[30,36,41],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"PROCEDURE","Endoscopic resection","Eligible patients will undergo endoscopic submucosal dissection (ESD) or endoscopic intermuscular dissection (EID) after two to eight weeks of nCRT completion, depending on the used neo-adjuvant regimen. Procedures will be performed using the GIF EZ-1500 endoscope (Olympus America, Center Valley, PA, USA) and an electrosurgical unit (VIO 300 D; Erbe, Germany) to power the electrosurgical knife (1.5-mm DualKnife J, Olympus America). For mucosal incision, Endocut or Drycut mode will be used, while Precise, Swift or Spray Coagulation modes will support submucosal dissection and hemostasis. An initial submucosal lift will be created by Glycéol Gel injection. The ERBE Flushing Pump (Erbe, Germany) will supply further submucosal lift during dissection through foot pedal-controlled, pressurized injections of methylene blue and saline solution delivered via the DualKnife J's ceramic-tipped tubing.",[9,21,15],null,{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":35},"BEHAVIORAL","Short interval restaging","Close follow-up and endoscopic re-evaluation four to eight weeks after the initial evaluation\\*.\n\n\\*Defined as the first endoscopic evaluation after completion of the neoadjuvant treatment",[21,15],{"type":31,"name":42,"description":43,"armGroupLabels":44,"otherNames":35},"Total mesorectal excision","This technique consists of the surgical complete removal of the rectum, together with the surrounding mesorectum lymphovascular fatty tissue (mesorectum).",[21,15,25],[46,51],{"name":47,"role":48,"phone":49,"phoneExt":35,"email":50},"Mariana Figueiredo","CONTACT","+32 23533332","mariana.figueiredo@stpierre-bru.be",{"name":52,"role":48,"phone":53,"phoneExt":35,"email":54},"Amélie Deleporte","+32 25354144","amelie.deleporte@stpierre-bru.be",[56],{"facility":57,"status":58,"city":59,"state":35,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"CHU Saint Pierre","RECRUITING","Brussels","1000","Belgium","BE",{"type":64,"coordinates":65},"Point",[66,67],4.34878,50.85045,{"lat":67,"lon":66},[70],{"name":71,"role":48,"phone":72,"phoneExt":35,"email":50},"Mariana Figueiredo, Medical doctor","+32 25353332",{"type":74,"investigatorFullName":47,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"PRINCIPAL_INVESTIGATOR","Medical Doctor (Gastroenterology, Therapeutic Endoscopy and Digestive Oncology)","100574592","optimizing-patient-selection-for-surgery-using-pathologic-analysis-following-neoadjuvant-therapy-in-locally-advanced-rectal-cancer-100574592",false,"NCT06761287","Optimizing Patient Selection for Surgery Using Pathologic Analysis Following Neoadjuvant Therapy in Locally Advanced Rectal Cancer","Role of Local Endoscopic Excision After Neoadjuvant Therapy in Locally Advanced Rectal Cancer: A Prospective Study","OPAL","Inclusion Criteria:\n\n* Age \\> 18 years old\n* Signed informed consent\n* Patients diagnosed with locally advanced rectal cancer showing complete or near-complete clinical response after neoadjuvant therapy without evidence of invasive disease (\\>T2) or locoregional invasion on magnetic resonance imaging and without any signs of metastatic disease on a computerized tomography scan.\n* Patients diagnosed with locally advanced rectal cancer showing incomplete response with presence of superficial residual lesions, without invasive features on endoscopic evaluation, without evidence of invasive disease (\\>T2) or locoregional invasion on magnetic resonance imaging and without any signs of metastatic disease on a computerized tomography scan.\n* Without previous medical history of rectal cancer or rectal surgery\n\nExclusion Criteria:\n\n* Previous medical history of rectal cancer\n* Previous rectal surgery","ALL","18 Years",{"count":87,"type":88},20,"ESTIMATED","INTERVENTIONAL",[91],"NA","This interventional, non-randomized, prospective trial aims to evaluate the role of endoscopic resection following neoadjuvant treatment in patients with locally advanced rectal cancer.\n\nPhase I focuses on assessing the feasibility, safety and efficacy of endoscopic resection of residual scar or superficial residual neoplastic tissue following neoadjuvant treatment.\n\nPhase II explores the potential of this approach to guide patient selection for total mesorectal excision and to serve as a definitive treatment option for those with limited residual disease.",[94],"Locally Advanced Rectal Cancer (LARC)",[96,97,98,99,100,101,102],"locally advanced rectal cancer","neoadjuvant","endoscopic resection","endoscopic submucosal dissection","endoscopic intermuscular dissection","feasibility","safety","2025-05-25",{"date":105,"type":106},"2025-05-30","ACTUAL",{"date":108,"type":106},"2025-03-28",{"date":110,"type":88},"2030-12",{"name":5,"class":6},1]