[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05468008":3,"trial-entities:NCT05468008":108,"trial-summary:NCT05468008":112},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":34,"secondary_outcomes":39,"sex":53,"minimum_age":54,"maximum_age":24,"healthy_volunteers":15,"eligibility_criteria":55,"std_ages":63,"locations":66,"central_contacts":82,"overall_officials":84,"references":87,"see_also_links":107},"NCT05468008","1798539","Endoscopic Submucosal Dissection (ESD)","Prospective Evaluation of the Clinical Utility of Endoscopic Submucosal Dissection (ESD) in Western Population","RECRUITING","2027-12","2026-01","2026-02-02","2022-02-04","AdventHealth","OTHER",false,"This registry is to evaluate the procedural and clinical outcomes in patients undergoing endoscopic submucosal dissection. All patients will receive standard of medical care and no experimental interventions will be performed.","The technique of Endoscopic Mucosal Resection (EMR) is currently widely used in the US to remove precancerous or cancerous lesions confined to the mucosa of the GI tract. EMR carries lower morbidity and mortality compare to surgery, at the expense of a higher rate of piecemeal removal, incomplete resection and cancer recurrence. Endoscopic Submucosal Dissection (ESD) is a newer technique developed in Japan that involves en-bloc resection of the entire lesion irrespective of size, allowing for a detailed analysis of the resected margins and depth of invasion and producing a lower local recurrence. Due to the lack of dedicated ESD devices the procedure has not been disseminated in Western countries. Recently the Food and Drug Administration (FDA) approved a number of devices for ESD. The vast majority of studies evaluating the clinical outcomes from ESD are originating in Japan where the technique is mostly applied to patients with early gastric cancer (Japan has the highest incidence of gastric cancer in the word). In the US lesions that are currently treated with EMR are mostly located in the esophagus (Barrett esophagus) and colon (large adenomatous polyps and intramucosal cancer). These esophageal and colonic lesions can be treated with ESD with expected higher rate of en-block resection and lower recurrence rate compare to EMR. With the differences in patient population and disease location one can anticipate some differences in outcomes between ESD performed in Asian and US patients. Therefore, the investigator wants to prospectively record the experience with ESD done as part of routine medical care in United States (US) population. This will be a prospective data recording study. All patients will receive standard medical care and no experimental interventions will be performed.",[19,20,21],"Esophageal Lesion","Barrett Esophagus","Gastrointestinal Lesions",[],"OBSERVATIONAL",null,[],{"count":27,"type":28},1000,"ESTIMATED",[30],{"type":31,"name":32,"description":33},"PROCEDURE","Endoscopic Submucosal Dissection","Endoscopic submucosal dissection (ESD) is an outpatient procedure to remove deep tumors from the gastrointestinal (GI) tract",[35],{"measure":36,"description":37,"timeFrame":38},"Evaluate the utility of ESD for treatment of gastrointestinal lesions","The primary endpoint of this study will be the prospective evaluation of the utility of ESD for the endoscopic treatment of GI lesions.","12 months",[40,44,47,50],{"measure":41,"description":42,"timeFrame":43},"En-Bloc Resection Rate","1)This is the proportion of lesions that are resected en-bloc (in one piece) using ESD","6 months",{"measure":45,"description":46,"timeFrame":43},"Complete Resection Rate","2\\) This is the proportion of lesions that are completely resected (clean lateral and deep resection margins) with ESD.",{"measure":48,"description":49,"timeFrame":43},"Curative Resection Rate","3\\) This is the proportion of lesions that are considered to have been cured based on endoscopic and histological criteria",{"measure":51,"description":52,"timeFrame":38},"Safety- Adverse Events","4\\) This will be measured based on the rate of adverse events with the procedure","ALL","18 Years",{"inclusion":56,"exclusion":59,"raw_text":62},[57,58],"Age 18 years or older","Scheduled to undergo ESD",[60,61],"Any contraindication to performing endoscopy","Participation in another research protocol that could interfere or influence the outcomes measures of the present study.","Inclusion Criteria:\n\n* Age 18 years or older\n* Scheduled to undergo ESD\n\nExclusion Criteria:\n\n* Any contraindication to performing endoscopy\n* Participation in another research protocol that could interfere or influence the outcomes measures of the present study.",[64,65],"ADULT","OLDER_ADULT",[67],{"facility":68,"status":8,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":79},"AdventHealth Orlando","Orlando","Florida","32803","United States",[74],{"name":75,"role":76,"phone":77,"email":78},"Dennis Yang, MD","CONTACT","407-303-2570","Dennis.Yang.MD@adventhealth.com",{"lat":80,"lon":81},28.53834,-81.37924,[83],{"name":75,"role":76,"phone":77,"email":78},[85],{"name":75,"affiliation":68,"role":86},"PRINCIPAL_INVESTIGATOR",[88,92,95,98,101,104],{"pmid":89,"type":90,"citation":91},"30022521","BACKGROUND","Kotzev AI, Yang D, Draganov PV. How to master endoscopic submucosal dissection in the USA. Dig Endosc. 2019 Jan;31(1):94-100. doi: 10.1111\u002Fden.13240. Epub 2018 Aug 22.",{"pmid":93,"type":90,"citation":94},"32504699","Yang D, Wagh MS, Draganov PV. The status of training in new technologies in advanced endoscopy: from defining competence to credentialing and privileging. Gastrointest Endosc. 2020 Nov;92(5):1016-1025. doi: 10.1016\u002Fj.gie.2020.05.047. Epub 2020 Jun 3.",{"pmid":96,"type":90,"citation":97},"25652022","Tanaka S, Kashida H, Saito Y, Yahagi N, Yamano H, Saito S, Hisabe T, Yao T, Watanabe M, Yoshida M, Kudo SE, Tsuruta O, Sugihara KI, Watanabe T, Saitoh Y, Igarashi M, Toyonaga T, Ajioka Y, Ichinose M, Matsui T, Sugita A, Sugano K, Fujimoto K, Tajiri H. JGES guidelines for colorectal endoscopic submucosal dissection\u002Fendoscopic mucosal resection. Dig Endosc. 2015 May;27(4):417-434. doi: 10.1111\u002Fden.12456. Epub 2015 Mar 5.",{"pmid":99,"type":90,"citation":100},"30267866","Yang D, Othman M, Draganov PV. Endoscopic Mucosal Resection vs Endoscopic Submucosal Dissection For Barrett's Esophagus and Colorectal Neoplasia. Clin Gastroenterol Hepatol. 2019 May;17(6):1019-1028. doi: 10.1016\u002Fj.cgh.2018.09.030. Epub 2018 Sep 26.",{"pmid":102,"type":90,"citation":103},"29435819","Yang D, Draganov PV. Expanding Role of Third Space Endoscopy in the Management of Esophageal Diseases. Curr Treat Options Gastroenterol. 2018 Mar;16(1):41-57. doi: 10.1007\u002Fs11938-018-0169-z.",{"pmid":105,"type":90,"citation":106},"28254526","Fuccio L, Hassan C, Ponchon T, Mandolesi D, Farioli A, Cucchetti A, Frazzoni L, Bhandari P, Bellisario C, Bazzoli F, Repici A. Clinical outcomes after endoscopic submucosal dissection for colorectal neoplasia: a systematic review and meta-analysis. Gastrointest Endosc. 2017 Jul;86(1):74-86.e17. doi: 10.1016\u002Fj.gie.2017.02.024. Epub 2017 Feb 28.",[],{"nct_id":4,"conditions":109,"biomarkers":111},[20,19,110],"Gastrointestinal sensation",[],{"nct_id":4,"found":113,"summary":114,"prompt_version":124},true,{"design":115,"status":116,"heading":117,"summary":118,"follow_up":119,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"This is an observational study, meaning researchers will watch and collect information about patients undergoing a standard medical procedure. There is no specified phase for this study, and it plans to enroll 1000 participants.","completed","Observational Study of Endoscopic Submucosal Dissection (ESD)","This study is looking at a procedure called Endoscopic Submucosal Dissection (ESD). ESD is a way to remove deep growths or lesions from your gastrointestinal (GI) tract, which includes areas like your esophagus (food pipe). This procedure is done as an outpatient, meaning you don't stay overnight in the hospital. The study aims to see how well ESD works for treating lesions in the GI tract, including those related to Barrett Esophagus. You can join if you are 18 or older and are already scheduled to have an ESD procedure. The study will follow your progress for 12 months to see the results. This is an observational study, meaning you will receive standard medical care, and no experimental treatments are involved. The study is currently unclear about its recruitment status and plans to enroll 1000 participants.","The study will evaluate the utility of ESD for treatment of gastrointestinal lesions at 12 months.",136,"You would be participating if you are already scheduled to undergo Endoscopic Submucosal Dissection (ESD). All patients will receive standard medical care.","Not stated in the trial record.",[32],"v2"]