[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542865":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":51,"collaborators":55,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":18,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Qilu Hospital of Shandong University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ARMV (intervention group)","EXPERIMENTAL","Under general anesthesia, patients are positioned in the left lateral decubitus position and undergo endoscopic examination of the esophagus and stomach. The surgery utilizes a single-channel gastroscope (EG29-i10, Pentax, Japan, or GIF-H290T, Olympus, Japan) and a high-frequency generator (VIO300D, Erbe, Germany). A transparent cap (D-201, Olympus, Japan) is attached to the gastroscope to improve visualization and aid in manipulating the flap valve. The DualKnife (Olympus, Japan) is selected for dissection due to its maneuverability in a retroflexed fashion. For patients with esophageal strictures obstructing scope passage, esophageal dilation is performed using Savary-Gilliard dilators (Cook Medical, USA) just before ARMV.",[13],"Procedure: anti-reflux mucosal valvuloplasty (ARMV)",{"label":15,"type":16,"description":17,"interventionNames":18},"PPI (control group)","NO_INTERVENTION","Patients randomized to the PPI group will follow the PPI treatment scheme. If GERD symptoms are effectively controlled with their current PPI dosage for at least one month, the regimen is decreased by one step. Conversely, if symptoms are poorly controlled, the dosage is increased by one step based on the PPI algorithm, which aligns with best clinical practices. The use of PPI will be recorded in medication diaries using generic names listed in the table below and classified according to the daily dose and frequency. Dosage will be categorized as \"double dose\" = ≥30 or 40 mg per day, \"full dose\" = 30 or 40 mg per day, \"half dose\" = 15 or 20 mg per day, \"occasional\" or \"on demand\" = \\\u003C \"full dose\" taken for \\\u003C 50% of days in the follow-up period. Common medications include Nexium 20mg、Prevacid 30mg、Prilosec 20mg、Protonix 20mg、Aciphex20mg.The frequency of medication use is once a day.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","anti-reflux mucosal valvuloplasty (ARMV)","During the ARMV procedure, a segment of the mucosa at the esophagogastric junction (EGJ) is released and reconstructed to form a mucosal flap. Cautery markings are made on 3\u002F4-4\u002F5 of the mucosa along the lesser curvature, approximately 2 cm below the dentate line. After submucosal injection of saline with indigocarmine, the premarked mucosa is dissected from the caudal to cranial side using an endoscopic submucosal dissection technique. The cranial edge of the released mucosa is left in place, and the semi-free mucosa naturally curls to form a double-layer flap. Metal clips are then used to anchor the free edge of the mucosa to the exposed submucosa\u002Fsmooth muscle to prevent flattening of the mucosal flap. Any visible bleeding on the exposed submucosa is coagulated using electric forceps.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"jiaoyang j lu","CONTACT","18560089069","lujiaoyang@sdu.edu.cn",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Qilu Hospital of Shandong University, Department of Gastroenterology and Endoscopy Center","RECRUITING","Jinan","Shandong","250000","China","CN",{"type":41,"coordinates":42},"Point",[43,44],116.99722,36.66833,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":49,"phoneExt":18,"email":50},"xiaofen lv","15670188361","lxf202215602@163.com",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Lu Jiaoyang","professor",[56],{"name":57,"class":6},"Shandong University","100542865","anti-reflux-mucosal-valvuloplasty-versus-ppis-for-gerd-treatment-100542865",false,"NCT06348420","Anti-reflux Mucosal Valvuloplasty Versus PPIs for GERD Treatment","Anti-reflux Mucosal Valvuloplasty Versus Proton Pump Inhibitors for the Treatment of Patients With Gastroesophageal Reflux Disease in a Tertiary Healthcare Center in China: Study Protocol for a Randomized Controlled Trial","ARMV","Inclusion Criteria:\n\n* 18-60 years of age;\n* Hiatal hernia ≤ 2 cm;\n* Sliding hernia ≤ 2 cm;\n* Recurrence of GERD symptoms after cessation of PPIs;\n* On daily PPI for ≥1 year or twice daily PPI for at least 8 weeks;\n* Esophagitis (Los Angeles Classification) Grade B, C, or D;\n* Hill's flap valve grade ≤ III;\n* Observation of distal esophageal pH \\\u003C 4 on at least 1-2 days within a 7-day period, with a percentage exceeding 5.3%;\n* Normal or near-normal esophageal motility;\n* Lower esophageal sphincter pressure (LESP) ranging between 5-15 mmHg;\n* DeMeester score ≥ 14.7 or total reflux episodes exceeding 73;\n* Completion of a signed informed consent form.\n\nExclusion Criteria:\n\n* BMI \\> 35 kg\u002Fm2;\n* ASA \\> II;\n* Barrett's esophagus;\n* Hiatal hernia \\> 2 cm;\n* Esophagitis (Los Angeles Classification) Grade A or No esophagitis；\n* Hill's flap valve grade \\> III；\n* Peptic ulcer disease;\n* Primary esophageal motility disorders such as achalasia;\n* Severe gastroparesis;\n* History of previous esophageal or gastric surgery, including ARMS or ARMA;\n* Uncontrolled systemic diseases;\n* Gastric outlet obstruction;\n* Pregnancy or planning to become pregnant.","ALL","18 Years","60 Years",{"count":70,"type":71},74,"ESTIMATED","INTERVENTIONAL",[74],"NA","The study objective is to evaluate the relative merits, safety and effectiveness of Anti-reflux mucosal valvuloplasty (ARMV) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs).",[77],"Gastroesophageal Reflux Disease",[79,80,81,82],"Endoscopic anti-reflux","Proton pump inhibitor","Randomized controlled trial","Gastroesophageal reflux disease","2024-11-14",{"date":85,"type":86},"2024-11-18","ACTUAL",{"date":88,"type":86},"2024-09-10",{"date":90,"type":71},"2028-12-30",{"name":5,"class":6},1]