[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519329":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":39,"responsibleParty":150,"collaborators":153,"id":165,"slug":166,"hasResults":167,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":26,"eligibilityCriteria":171,"healthyVolunteers":167,"sex":172,"minAge":173,"maxAge":174,"enrollmentInfo":175,"targetDuration":26,"studyType":178,"phases":179,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":79,"whyStopped":26,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":197},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Per-oral endoscopic myotomy with fundoplication","EXPERIMENTAL","The detail of the procedure has been reported in the literature. After completion of myotomy as per conventional anterior POEM, a serosal incision would be made at the level of the GE junction below the diaphragmatic crus. The peritoneal cavity would then be entered and the anterior gastric wall could be identified. A detachable endoloop would be introduced alongside the endoscope with the guidance of endoscopic clip. Three to four clips would be applied to the anterior gastric fundus while additional 3-4 clips would be applied to the edge of the submucosal tunnel, all anchoring to the endoloop. Upon tightening of the endoloop the anterior fundus would be approximated to the esophagogastric junction and thus completing the partial anterior fundoplication. Abdominal paracentesis to treat capnoperitoneum would be performed as required based on patient's clinical condition.",[13],"Procedure: POEM-F",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional POEM","ACTIVE_COMPARATOR","Conventional per-oral endoscopic myotomy An anterior POEM would be performed per usual manner described in the literature. The procedure would be performed under general anaesthesia by expert endoscopists with at least 50 case experience of conventional POEM and 5 cases experience of POEM-F. The requirement of POEM experience is based on a recent multicenter study of learning curve by Fujiyoshi Y, et al. The procedure would follow the current recommendations from expert panel in reducing GER, including avoidance of excessive gastric myotomy and preservation of the sling fibers are the gastric cardia. The length of the esophageal and gastric myotomy is standardized at 5cm and 2cm respectively",[19],"Procedure: Conventional POEM",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","POEM-F","POEM-F would be performed as described in the arms section",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Anterior POEM performed as described in the arms section",[15],[31],{"name":32,"affiliation":5,"role":33},"Hon Chi Yip, FRCSEd","PRINCIPAL_INVESTIGATOR",[35],{"name":32,"role":36,"phone":37,"phoneExt":26,"email":38},"CONTACT","35052627","hcyip@surgery.cuhk.edu.hk",[40,62,77,90,105,120,137],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Johns Hopkins Hospital","NOT_YET_RECRUITING","Baltimore","Maryland","21287","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-76.61219,39.29038,{"lat":52,"lon":51},[55,58,61],{"name":56,"role":36,"phone":26,"phoneExt":26,"email":57},"Mouen Khashab","mkhasha1@jhmi.edu",{"name":59,"role":60,"phone":26,"phoneExt":26,"email":26},"Farimah Fayyaz","SUB_INVESTIGATOR",{"name":56,"role":33,"phone":26,"phoneExt":26,"email":26},{"facility":63,"status":42,"city":64,"state":26,"zip":26,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Nanfang Hospital, Southern Medical University","Guangzhou","China","CN",{"type":49,"coordinates":68},[69,70],113.25,23.11667,{"lat":70,"lon":69},[73,76],{"name":74,"role":36,"phone":26,"phoneExt":26,"email":75},"Xiaobei Luo","luoxiaobei63@126.com",{"name":74,"role":33,"phone":26,"phoneExt":26,"email":26},{"facility":78,"status":79,"city":80,"state":26,"zip":26,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"The Chinese University of Hong Kong","RECRUITING","Hong Kong","HK",{"type":49,"coordinates":83},[84,85],114.17469,22.27832,{"lat":85,"lon":84},[88],{"name":32,"role":36,"phone":89,"phoneExt":26,"email":38},"+85235052627",{"facility":91,"status":42,"city":92,"state":26,"zip":26,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Post Graduate Institute of Medical Education and Research","Chandigarh","India","IN",{"type":49,"coordinates":96},[97,98],76.7884,30.73629,{"lat":98,"lon":97},[101,104],{"name":102,"role":36,"phone":26,"phoneExt":26,"email":103},"Jayanta Samanta","dj_samanta@yahoo.co.in",{"name":102,"role":33,"phone":26,"phoneExt":26,"email":26},{"facility":106,"status":42,"city":107,"state":26,"zip":26,"country":93,"countryCode":94,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Asian Institute of Gastroenterology","Hyderabad",{"type":49,"coordinates":109},[110,111],78.45636,17.38405,{"lat":111,"lon":110},[114,117,118],{"name":115,"role":36,"phone":26,"phoneExt":26,"email":116},"Mohan Ramchandani","ramchandanimohan@gmail.com",{"name":115,"role":33,"phone":26,"phoneExt":26,"email":26},{"name":119,"role":60,"phone":26,"phoneExt":26,"email":26},"Nabi Zaheer",{"facility":121,"status":42,"city":122,"state":26,"zip":26,"country":93,"countryCode":94,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Baldota Institute of Digestive Sciences","Mumbai",{"type":49,"coordinates":124},[125,126],72.88261,19.07283,{"lat":126,"lon":125},[129,132,133,135],{"name":130,"role":36,"phone":26,"phoneExt":26,"email":131},"Amit Maydeo","amitmaydeo@gmail.com",{"name":130,"role":33,"phone":26,"phoneExt":26,"email":26},{"name":134,"role":60,"phone":26,"phoneExt":26,"email":26},"Gaurav Patil",{"name":136,"role":60,"phone":26,"phoneExt":26,"email":26},"Amat Nagesh",{"facility":138,"status":42,"city":139,"state":26,"zip":26,"country":93,"countryCode":94,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Deenanath Mangeshkar Hospital & Research Center","Pune",{"type":49,"coordinates":141},[142,143],73.85535,18.51957,{"lat":143,"lon":142},[146,149],{"name":147,"role":36,"phone":26,"phoneExt":26,"email":148},"Amol Bapaye","amolbapaye@gmail.com",{"name":147,"role":33,"phone":26,"phoneExt":26,"email":26},{"type":33,"investigatorFullName":151,"investigatorTitle":152,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Hon Chi Yip","Assistant Professor",[154,156,158,160,161,163],{"name":155,"class":6},"Deenanath Mangeshkar Hospital and Research Centre",{"name":157,"class":6},"Johns Hopkins University",{"name":159,"class":6},"Northwestern University",{"name":63,"class":6},{"name":162,"class":6},"Asian Institute of Gastroenterology, India",{"name":164,"class":6},"Post Graduate Institute of Medical Education and Research, Chandigarh","100519329","poem-f-for-achalasia-international-study-100519329",false,"NCT06042127","POEM-F for Achalasia International Study","Per-oral Endoscopic Myotomy With Fundoplication for Achalasia - an International Multicenter Randomized Controlled Trial","Inclusion criteria:\n\n1. Adult patient (age ≥18 and ≤65 years-old) and with symptomatic achalasia type I or II.\n2. Capability of understanding and complying with the study requirements, including filling the Eckardt Score, GERD-HRQL and RSI questionnaire and signing the informed consent form.\n3. Patients with achalasia type I, II or III who are one of the following:\n\n   * Treatment naïve, or\n   * Failed prior through-the-scope balloon dilation, Savary or pneumatic dilation\n\nExclusion criteria:\n\n1. Patients unable or unwilling to provide consent.\n2. Previous esophageal or gastric surgery.\n3. Prior achalasia treatment including Heller myotomy, POEM.\n4. Sigmoid achalasia, or significant esophageal dilatation \\>6cm in lower esophagus\n5. Disrupted mucosal integrity at the distal esophagus, eg. Ulcer, fibrotic scars etc\n6. Patients with large hiatal hernias (axial length \\> 2 cm and Hill grade \\>2).\n7. Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake general anesthesia for the procedure, including ASA grade III or above.\n8. Patients with obesity (Body Mass Index (BMI) ≥ 30).\n9. Pregnant women or those planning pregnancy or breastfeeding women.\n10. Uncorrectable coagulopathy defined by international normalized ratio (INR) \\> 1.5 or platelet count \\\u003C 50000\u002Fµl.","ALL","18 Years","65 Years",{"count":176,"type":177},81,"ESTIMATED","INTERVENTIONAL",[180],"NA","Per-oral endoscopic myotomy (POEM) has emerged as the endoscopic treatment of choice for achalasia, offering comparable symptom relief with laparoscopic Heller's cardiomyotomy. The main concern with POEM is the higher incidence of post-procedure gastroesophageal reflux disease (GERD), occurring in up to 50-60% of patients. In order to reduce the risk of GERD, endoscopic fundoplication has been developed as a novel procedure mimicking surgical anterior partial fundoplication that can be performed in the same session as POEM (POEM-F). Case series of POEM-F in patients with achalasia reported encouraging outcomes of low GERD rate of \\~12% at 1 year. Prospective comparative data between POEM-F and conventional POEM on post-procedure GERD is current lacking. The investigators therefore designed an international multicenter prospective randomized study to investigate the efficacy of POEM-F. The investigators postulate that POEM-F could reduce the incidence of post-procedure GERD when compared with conventional POEM.\n\nThis is an international multicenter randomized controlled trial conducted between high volume expert centers from Hong Kong SAR, China, India and United States of America. Adult patients with manometry confirmed achalasia would be randomised to undergo POEM-F or POEM. The procedure would be performed by experts with vast experience in POEM. The primary outcome is the incidence of post-procedure GERD at 1 year, defined by the updated Lyon consensus. Secondary outcomes include technical and clinical success rates, adverse events, post-POEM endoscopic and manometry findings as well as patients' symptom scores.\n\nSample size calculation Based on existing pilot comparative data on POEM-F and POEM, it is estimated that 84 patients would be required to demonstrate a difference in post-procedure GERD of 47.6% to 18.2%, with 80% power and false positive rate of 0.05, accounting for 10% loss to follow-up.\n\nPurpose and potential The current study proposal could demonstrate the superiority of POEM-F over POEM in reducing post-procedural GERD. It would also demonstrate the safety and reproducibility of the technique in expert centers across the globe. It could potentially replace conventional POEM as the preferred minimally invasive endoscopic treatment for achalasia.",[183],"Achalasia",[185,186,187],"POEM","Fundoplication","GERD","2024-11-29",{"date":190,"type":191},"2024-12-03","ACTUAL",{"date":193,"type":191},"2023-12-01",{"date":195,"type":177},"2026-10-31",{"name":5,"class":6},7]