[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658324":3},{"organization":4,"outcomesModule":7,"designInfo":59,"detailedDescription":58,"studyPopulation":58,"armGroups":68,"interventions":81,"overallOfficials":58,"centralContacts":94,"locations":58,"responsibleParty":100,"collaborators":58,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":106,"sex":112,"minAge":113,"maxAge":58,"enrollmentInfo":114,"targetDuration":58,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":128,"whyStopped":58,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":58},{"fullName":5,"class":6},"Pusan National University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":58},[9],{"measure":10,"description":11,"timeFrame":12},"Resection speed","Resection speed will be calculated as the resected specimen area (mm²) divided by the submucosal dissection time (min). The resected specimen area will be calculated using the ellipse formula: π × (major axis\u002F2) × (minor axis\u002F2). Submucosal dissection time will be measured from the start of submucosal dissection to complete resection of the lesion. The outcome will be expressed as mm²\u002Fmin.","During the ESD procedure, from the start of submucosal dissection to complete lesion resection",[14,18,22,25,28,32,35,38,41,44,48,52,55],{"measure":15,"description":16,"timeFrame":17},"Total Procedure Time","Total procedure time will be measured from the start of the initial lesion marking to complete resection of the lesion and will be expressed in minutes.","At completion of the ESD procedure",{"measure":19,"description":20,"timeFrame":21},"Submucosal Dissection Time","Submucosal dissection time will be measured from the start of submucosal dissection to complete resection of the lesion and will be expressed in minutes.","During the ESD procedure",{"measure":23,"description":24,"timeFrame":21},"Traction Application Time","Time during which the traction device is applied during the ESD procedure in participants assigned to the traction-assisted ESD group, expressed in minutes.",{"measure":26,"description":27,"timeFrame":17},"En Bloc Resection Rate","The proportion of participants in whom the target lesion is resected in a single piece.",{"measure":29,"description":30,"timeFrame":31},"R0 Resection Rate","The proportion of participants with histologically complete resection, defined as both negative horizontal and negative vertical resection margins.","Postprocedurally, generally within 1 month after ESD",{"measure":33,"description":34,"timeFrame":31},"Horizontal Resection Margin Status","The proportion of participants with a histologically negative horizontal resection margin.",{"measure":36,"description":37,"timeFrame":31},"Vertical Resection Margin Status","The proportion of participants with a histologically negative vertical resection margin.",{"measure":39,"description":40,"timeFrame":31},"Horizontal Resection Margin Distance","The shortest histopathologic distance from the lateral tumor edge to the horizontal resection margin will be measured in millimeters on the resected specimen.",{"measure":42,"description":43,"timeFrame":31},"Vertical Resection Margin Distance","The shortest histopathologic distance from the deepest tumor edge to the vertical resection margin will be measured in millimeters on the resected specimen.",{"measure":45,"description":46,"timeFrame":47},"Procedure-Related Adverse Events","The incidence of procedure-related adverse events, including intraprocedural bleeding, delayed bleeding, intraprocedural perforation, delayed perforation, muscularis propria injury, post-ESD coagulation syndrome, and the need for additional endoscopic or surgical treatment.","From the start of ESD through 1 month after the procedure",{"measure":49,"description":50,"timeFrame":51},"Length of Hospital Stay","Length of hospital stay after the ESD procedure, measured in days.","Periprocedural",{"measure":53,"description":54,"timeFrame":51},"Time to Diet Resumption","Time from completion of the ESD procedure to resumption of oral diet.",{"measure":56,"description":57,"timeFrame":47},"Unplanned Emergency Department Visit or Readmission","The proportion of participants who experience an unplanned emergency department visit or hospital readmission after the ESD procedure.",null,{"allocation":60,"interventionModel":61,"interventionModelDescription":58,"primaryPurpose":62,"observationalModel":58,"timePerspective":58,"maskingInfo":63},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":64,"maskingDescription":58,"whoMasked":65},"DOUBLE",[66,67],"PARTICIPANT","OUTCOMES_ASSESSOR",[69,75],{"label":70,"type":71,"description":72,"interventionNames":73},"Traction-Assisted Endoscopic Submucosal Dissection","EXPERIMENTAL","Participants assigned to this arm will undergo traction-assisted endoscopic submucosal dissection (T-ESD).",[74],"Procedure: Traction-Assisted Endoscopic Submucosal Dissection",{"label":76,"type":77,"description":78,"interventionNames":79},"Conventional Endoscopic Submucosal Dissection","ACTIVE_COMPARATOR","Participants assigned to this arm will undergo conventional endoscopic submucosal dissection (C-ESD).",[80],"Procedure: Conventional Endoscopic Submucosal Dissection",[82,89],{"type":83,"name":70,"description":84,"armGroupLabels":85,"otherNames":86},"PROCEDURE","After submucosal injection and mucosal incision, a standardized traction device will be applied to the lesion to provide traction and improve visualization of the submucosal layer.",[70],[87,88],"T-ESD","TA-ESD",{"type":83,"name":76,"description":90,"armGroupLabels":91,"otherNames":92},"After submucosal injection, mucosal incision and submucosal dissection will be performed using conventional endoscopic submucosal dissection techniques without use of a traction device",[76],[93],"C-ESD",[95],{"name":96,"role":97,"phone":98,"phoneExt":58,"email":99},"Seung Min Hong, M.D., Ph.D.","CONTACT","+82-51-240-7869","lucky77i@naver.com",{"type":101,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":58,"oldOrganization":58},"PRINCIPAL_INVESTIGATOR","Seung Min Hong","Assistant professor","100658324","traction-assisted-versus-conventional-endoscopic-submucosal-dissection-for-rectal-neuroendocrine-tumors-100658324",false,"NCT07848360","Traction-Assisted Versus Conventional Endoscopic Submucosal Dissection for Rectal Neuroendocrine Tumors","Traction-assisted Versus Conventional Endoscopic Submucosal Dissection for Rectal Neuroendocrine Tumors: A Prospective Randomized Study","TRACE-NET","Inclusion Criteria:\n\n* Adults aged 19 years or older.\n* Patients diagnosed with or strongly suspected of having a rectal neuroendocrine tumor on colonoscopy.\n* Lesion size generally 15 mm or less, without suspected muscularis propria invasion on endoscopy and, when clinically indicated, endoscopic ultrasonography.\n* No suspected lymph node metastasis or distant metastasis based on abdominal\u002Fpelvic imaging or clinical assessment.\n* Lesions considered appropriate for endoscopic resection.\n* Ability to understand the purpose and procedures of the study and provide written informed consent.\n\nExclusion Criteria:\n\n* Suspected muscularis propria invasion, lymph node metastasis, or distant metastasis on endoscopy, endoscopic ultrasonography, imaging studies, or clinical assessment.\n* Lesion size greater than 15 mm, or a lesion considered by the investigator to require surgical treatment rather than endoscopic resection.\n* Conditions that make safe endoscopic submucosal dissection difficult, including inadequate bowel preparation.\n* Uncontrolled bleeding tendency, severe thrombocytopenia, or uncorrectable coagulation disorder.\n* Use of antiplatelet or anticoagulant therapy that cannot be appropriately discontinued or adjusted before the procedure.\n* Severe cardiopulmonary disease, hepatic failure, renal failure, or other conditions considered to make sedation or endoscopic submucosal dissection unsafe.\n* Pregnancy or breastfeeding.\n* Inability to provide informed consent or impaired decision-making capacity.\n* Altered anatomy of the rectum due to previous rectal surgery, radiotherapy, or other conditions that may interfere with standardization of the study procedure.\n* Any other condition considered by the principal investigator or study investigator to make participation inappropriate.","ALL","19 Years",{"count":115,"type":116},66,"ESTIMATED","INTERVENTIONAL",[119],"NA","This prospective, randomized pilot study will compare traction-assisted endoscopic submucosal dissection (T-ESD) with conventional endoscopic submucosal dissection (C-ESD) for the treatment of rectal neuroendocrine tumors. Patients with rectal neuroendocrine tumors generally measuring 15 mm or less, without suspected muscularis propria invasion, lymph node metastasis, or distant metastasis, who are considered suitable for endoscopic resection will be eligible for enrollment.\n\nParticipants will be randomly assigned in a 1:1 ratio to undergo either T-ESD or C-ESD. In the T-ESD group, a traction device will be used during submucosal dissection to improve visualization of the submucosal layer, whereas conventional ESD will be performed without routine use of a traction device.\n\nThe primary outcome is resection speed, calculated as the resected specimen area divided by the submucosal dissection time. Secondary outcomes include total procedure time, submucosal dissection time, en bloc and R0 resection rates, resection margin status, procedure-related adverse events, length of hospital stay, time to diet resumption, and unplanned emergency department visits or readmissions. The study is designed as an exploratory pilot trial to estimate the efficacy, safety, and variability of traction-assisted ESD and to provide preliminary data for the design of a future larger multicenter randomized trial.",[122],"Rectal Neuroendocrine Tumor",[124,125,126,127],"Rectal neuroendocrine tumor","Endoscopic submucosal dissection","Traction-assisted endoscopic submucosal dissection","Conventional endoscopic submucosal dissection","NOT_YET_RECRUITING","2026-09-25",{"date":131,"type":132},"2026-09-30","ACTUAL",{"date":134,"type":116},"2026-10-01",{"date":136,"type":116},"2027-12-31",{"name":5,"class":6}]