[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555401":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":61,"studyPopulation":54,"armGroups":62,"interventions":74,"overallOfficials":80,"centralContacts":85,"locations":54,"responsibleParty":91,"collaborators":54,"id":93,"slug":54,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":54,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":54,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":54,"overallStatus":111,"whyStopped":54,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":54},{"fullName":5,"class":6},"Changzhi People's Hospital Affiliated to Changzhi Medical College","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":54},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of patients with reflux esophagitis","The percentage (%) of patients developing postoperative reflux esophagitis after surgery in the two group.","Within 12 months after surgery",[14,17,21,24,27,30,33,36,39,42,45,48,51],{"measure":15,"description":16,"timeFrame":12},"Postoperative complications","Evaluated using the Clavien-Dindo classification to assess the severity of postoperative complications.",{"measure":18,"description":19,"timeFrame":20},"Operation time","From the beginning of surgery to the end of surgery","Perioperative period",{"measure":22,"description":23,"timeFrame":20},"Kamikawa anastomosis time","The time of making the seromuscular flap and the time of esophagogastrostomy were included",{"measure":25,"description":26,"timeFrame":20},"intraoperative blood loss","The operation begins to end the amount of bleeding.",{"measure":28,"description":29,"timeFrame":12},"Weight change","Calculated in kilograms",{"measure":31,"description":32,"timeFrame":12},"Body Mass Index (BMI)","weight and height will be combined to report BMI in kg\u002Fm\\^2",{"measure":34,"description":35,"timeFrame":12},"Albumin value","The concentration of albumin in the blood, expressed in g\u002FL.",{"measure":37,"description":38,"timeFrame":12},"Pre albumin value","The concentration of pre albumin in the blood, expressed in g\u002FL.",{"measure":40,"description":41,"timeFrame":12},"Hemoglobin value","The concentration of Hemoglobin in the blood, expressed in g\u002FL.",{"measure":43,"description":44,"timeFrame":12},"Folic acid value","The concentration of Folic acid value in the blood, expressed in ng\u002FmL.",{"measure":46,"description":47,"timeFrame":12},"Vitamin B12 value","The concentration of Vitamin B12 value in the blood, expressed in uug\u002FL.",{"measure":49,"description":50,"timeFrame":12},"Ferritin value","The concentration of Vitamin B12 value in the blood, expressed in ug\u002FL.",{"measure":52,"description":53,"timeFrame":12},"Nutritional risk screening 2002","The nutritional status is assessed using the Nutrition Risk Screening 2002 (NRS-2002) scale, with a scoring range of 0 to 7 points. A higher score indicates a worse nutritional status.",null,{"allocation":56,"interventionModel":57,"interventionModelDescription":54,"primaryPurpose":58,"observationalModel":54,"timePerspective":54,"maskingInfo":59},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":60,"maskingDescription":54,"whoMasked":54},"NONE","This study will enroll patients with proximal gastric cancer scheduled to undergo laparoscopic proximal gastrectomy. The patients will be randomly divided into two groups. One group will undergo laparoscopic proximal gastrectomy with double-flap technique (DFT) anastomosis, while the other group will undergo laparoscopic proximal gastrectomy with double-tract reconstruction (DTR). The primary endpoint is the proportion of patients who develop reflux esophagitis within 12 months after surgery. The secondary endpoints include postoperative complications, surgery-related indicators, and postoperative nutritional status.",[63,69],{"label":64,"type":65,"description":66,"interventionNames":67},"double-flap technique（DFT）","EXPERIMENTAL","Laparoscopic proximal gastrectomy with double flap anastomosis group",[68],"Procedure: double-flap technique（DFT）; double-tract reconstruction(DTR),",{"label":70,"type":71,"description":72,"interventionNames":73},"double-tract reconstruction（DTR）","ACTIVE_COMPARATOR","Laparoscopic proximal gastrectomy with double-tract anastomosis group",[68],[75],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":54},"PROCEDURE","double-flap technique（DFT）; double-tract reconstruction(DTR),","DFT (experiment group). Patients receive double flap technique after laparoscopic proximal gastrectomy. DTR (control group). Patients receive double-tract reconstruction after laparoscopic proximal gastrectomy.",[64,70],[81],{"name":82,"affiliation":83,"role":84},"WenQing Hu","502 Changxing Middle Road, Luzhou District, Changzhi City, Shanxi Province, China","STUDY_CHAIR",[86],{"name":87,"role":88,"phone":89,"phoneExt":54,"email":90},"WenQing Hu, Dr.","CONTACT","03552066898","beibeihejiyy@163.com",{"type":92,"investigatorFullName":54,"investigatorTitle":54,"investigatorAffiliation":54,"oldNameTitle":54,"oldOrganization":54},"SPONSOR","100555401",false,"NCT06511609","The Anti-reflux Effect of Double-flap Technique in Laparoscopic Proximal Gastrectomy.","Comparison of Anti-reflux Effects of Laparoscopic Proximal Gastrectomy With Double-flap Technique (Kamikawa Anastomosis) Versus Double-tract Reconstruction: A Prospective, Multicenter, Randomized Controlled Trial.","Inclusion Criteria:\n\n1. Age between 20 and 80 years, regardless of gender;\n2. Patients diagnosed with gastric cancer through tissue biopsy;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n4. American Society of Anesthesiologists (ASA) classification of I to III;\n5. Acceptable for laparoscopic proximal gastrectomy with preoperative examinations (based on endoscopic ultrasound and\u002For contrast-enhanced computed tomography of the thorax and abdomen) confirming the following oncological features:\n\n   Primary tumor located in the upper part of the stomach (proximal 1\u002F3 of the stomach) or gastroesophageal junction; Length of esophageal invasion ≤ 1 cm, tumor maximum diameter ≤ 4 cm; Preoperative staging T1-3N0M0 (based on AJCC 8th edition TNM clinical staging);\n6. Voluntary signing of informed consent.\n\nExclusion Criteria:\n\n1. Received preoperative chemotherapy, radiotherapy, targeted therapy, or immunotherapy;\n2. Presence of contraindications to surgery;\n3. Multiple malignant lesions in the stomach;\n4. Presence of other malignancies that may affect the preservation of stomach function;\n5. Previous upper abdominal surgery (excluding cholecystectomy);\n6. Preoperative examination reveals active peptic ulcer;\n7. Patients who have received or are currently receiving treatment for systemic inflammatory diseases;\n8. Pregnant or breastfeeding women;\n9. Conditions deemed unsuitable for participation in this study by the investigator.","ALL","20 Years","80 Years",{"count":103,"type":104},244,"ESTIMATED","INTERVENTIONAL",[107],"NA","This study is a multicenter, open-label, prospective, randomized parallel-controlled trial. The purpose is to explore whether the incidence rate of reflux esophagitis (RE) within 12 months after surgery is non-inferior for the DFT group compared to the DTR group.",[110],"Proximal Early Gastric Cancer","NOT_YET_RECRUITING","2024-07-15",{"date":114,"type":115},"2024-07-22","ACTUAL",{"date":117,"type":104},"2024-08-01",{"date":119,"type":104},"2027-07-31",{"name":5,"class":6}]