[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555319":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":232,"collaborators":25,"id":235,"slug":236,"hasResults":237,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":237,"sex":243,"minAge":244,"maxAge":245,"enrollmentInfo":246,"targetDuration":25,"studyType":249,"phases":250,"briefSummary":252,"conditions":253,"keywords":255,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":271},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Goal-directed enteral nutritional therapy","EXPERIMENTAL","The participants will be administered a supervised goal-directed nutritional therapy. The enteral nutrition (EN) regimens include homemade meals with or without ORAL IMPACT® according to the daily goal.",[13],"Dietary Supplement: Goal-directed EN therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional enteral nutritional therapy","ACTIVE_COMPARATOR","The participants will be administered with an unsupervised and liberal nutritional support. The EN regimens will not include ORAL IMPACT®.",[19],"Dietary Supplement: Conventional EN therapy",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Goal-directed EN therapy",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Conventional EN therapy","The participants will be administered the conventional nutritional therapy according to the Chinese expert consensus on perioperative nutritional support in enhanced recovery after surgery (2019 edition).",[15],[31],{"name":32,"affiliation":5,"role":33},"Yin Li, M.D.","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Xiaozheng Kang, M.D.","CONTACT","+86 13910052790","kangxz@cicams.ac.cn",[41,59,71,83,95,106,114,126,137,145,157,165,177,185,197,208,220],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Cancer Hospital Chinese Academy of Medical Sciences","RECRUITING","Beijing","Beijing Municipality","100021","China","CN",{"type":50,"coordinates":51},"Point",[52,53],116.39723,39.9075,{"lat":53,"lon":52},[56],{"name":32,"role":37,"phone":57,"phoneExt":25,"email":58},"+86 (010) 87788052","liyin@cicams.ac.cn",{"facility":60,"status":43,"city":61,"state":62,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Daping Hospital, Third Affiliated Hospital of Third Military Medical University","Chongqing","Chongqing Municipality",{"type":50,"coordinates":64},[65,66],106.55771,29.56026,{"lat":66,"lon":65},[69],{"name":70,"role":37,"phone":25,"phoneExt":25,"email":25},"Wei Guo, M.D.",{"facility":72,"status":43,"city":73,"state":74,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Fujian Cancer Hospital","Fuzhou","Fujian",{"type":50,"coordinates":76},[77,78],119.30611,26.06139,{"lat":78,"lon":77},[81],{"name":82,"role":37,"phone":25,"phoneExt":25,"email":25},"Shuoyan Liu, M.D.",{"facility":84,"status":43,"city":85,"state":86,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Anyang Cancer Hospital","Anyang","Henan",{"type":50,"coordinates":88},[89,90],114.38278,36.096,{"lat":90,"lon":89},[93],{"name":94,"role":37,"phone":25,"phoneExt":25,"email":25},"Anlin Hao, M.D.",{"facility":96,"status":43,"city":97,"state":86,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"First Affiliated Hospital of Zhengzhou University","Zhengzhou",{"type":50,"coordinates":99},[100,101],113.64861,34.75778,{"lat":101,"lon":100},[104],{"name":105,"role":37,"phone":25,"phoneExt":25,"email":25},"Xiangnan Li, M.D.",{"facility":107,"status":43,"city":97,"state":86,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":108,"geoPoint":110,"contacts":111},"Henan Cancer Hospital",{"type":50,"coordinates":109},[100,101],{"lat":101,"lon":100},[112],{"name":113,"role":37,"phone":25,"phoneExt":25,"email":25},"Yan Zheng, M.D.",{"facility":115,"status":43,"city":116,"state":117,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Huai'an First People's Hospital","Huai'an","Jiangsu",{"type":50,"coordinates":119},[120,121],119.01917,33.58861,{"lat":121,"lon":120},[124],{"name":125,"role":37,"phone":25,"phoneExt":25,"email":25},"Jianqiang Zhao, M.D.",{"facility":127,"status":43,"city":128,"state":117,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Jiangsu Cancer Hospital","Nanjing",{"type":50,"coordinates":130},[131,132],118.77778,32.06167,{"lat":132,"lon":131},[135],{"name":136,"role":37,"phone":25,"phoneExt":25,"email":25},"Feng Jiang, M.D.",{"facility":138,"status":43,"city":128,"state":117,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":139,"geoPoint":141,"contacts":142},"Jiangsu Provincial People's Hospital",{"type":50,"coordinates":140},[131,132],{"lat":132,"lon":131},[143],{"name":144,"role":37,"phone":25,"phoneExt":25,"email":25},"Jinhua Luo, M.D.",{"facility":146,"status":43,"city":147,"state":148,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Qilu Hospital of Shandong University","Jinan","Shandong",{"type":50,"coordinates":150},[151,152],116.99722,36.66833,{"lat":152,"lon":151},[155],{"name":156,"role":37,"phone":25,"phoneExt":25,"email":25},"Lin Li, M.D.",{"facility":158,"status":43,"city":147,"state":148,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":159,"geoPoint":161,"contacts":162},"Shandong Provincial Hospital",{"type":50,"coordinates":160},[151,152],{"lat":152,"lon":151},[163],{"name":164,"role":37,"phone":25,"phoneExt":25,"email":25},"Lin Zhang, M.D.",{"facility":166,"status":43,"city":167,"state":168,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Shanghai Chest Hospital","Shanghai","Shanghai Municipality",{"type":50,"coordinates":170},[171,172],121.45806,31.22222,{"lat":172,"lon":171},[175],{"name":176,"role":37,"phone":25,"phoneExt":25,"email":25},"Zhigang Li, M.D.",{"facility":178,"status":43,"city":167,"state":168,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":179,"geoPoint":181,"contacts":182},"Zhongshan Hospital Affiliated to Fudan University",{"type":50,"coordinates":180},[171,172],{"lat":172,"lon":171},[183],{"name":184,"role":37,"phone":25,"phoneExt":25,"email":25},"Lijie Tan, M.D.",{"facility":186,"status":43,"city":187,"state":188,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Changzhi People's Hospital","Changzhi","Shanxi",{"type":50,"coordinates":190},[191,192],113.10528,36.18389,{"lat":192,"lon":191},[195],{"name":196,"role":37,"phone":25,"phoneExt":25,"email":25},"Changhong Lian, M.D.",{"facility":198,"status":43,"city":199,"state":188,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"Shanxi Cancer Hospital, Chinese Academy of Medical Sciences","Taiyuan",{"type":50,"coordinates":201},[202,203],112.56028,37.86944,{"lat":203,"lon":202},[206],{"name":207,"role":37,"phone":25,"phoneExt":25,"email":25},"Jianhong Lian, M.D.",{"facility":209,"status":43,"city":210,"state":211,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Tianjin Medical University Cancer Institute & Hospital","Tianjin","Tianjin Municipality",{"type":50,"coordinates":213},[214,215],117.17667,39.14222,{"lat":215,"lon":214},[218],{"name":219,"role":37,"phone":25,"phoneExt":25,"email":25},"Peng Tang, M.D.",{"facility":221,"status":43,"city":222,"state":223,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"Yunnan Cancer Hospital","Kunming","Yunnan",{"type":50,"coordinates":225},[226,227],102.71833,25.03889,{"lat":227,"lon":226},[230],{"name":231,"role":37,"phone":25,"phoneExt":25,"email":25},"Guangqiang Zhao, M.D.",{"type":33,"investigatorFullName":233,"investigatorTitle":234,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"YIN LI","Principal Investigator","100555319","goal-directed-enteral-nutritional-perioperative-management-100555319",false,"NCT06510543","Goal-directed Enteral Nutritional Perioperative Management","Goal-directed Enteral Nutritional Therapy for Malnourished Esophageal Cancer Patients During Perioperative Management","GENTLEMAN","Inclusion Criteria:\n\n1. Aged 18-80 years old;\n2. ECOG PS 0\\~1;\n3. NRS 2002 score ≥3;\n4. Malnutrition diagnosed according to the GLIM criteria;\n5. Histopathologically confirmed as esophageal squamous cell carcinoma;\n6. Primary tumors located in thoracic esophagus;\n7. Resectable locally advanced disease with clinical stage II to IVA (8th edition UICC\u002FAJCC) evaluated by a multidisciplinary team;\n8. Neoadjuvant therapy will be administered, which may entail preoperative chemo-radiotherapy, chemotherapy only, or a combination of immunotherapy such as anti-PD-1\u002FPD-L1;\n9. Informed consent for random assignment and completion of the protocol.\n\nExclusion Criteria:\n\n1. NRS 2002 score \\\u003C 3;\n2. Upfront surgery without neoadjuvant treatment;\n3. Any comorbidity interferes with the digestion and absorption of ORAL IMPACT®;\n4. Receiving any other nutritional support during the study;\n5. Unable to consume nutrition orally or receive it through tube feeding before surgery;\n6. History of other malignancies in the past 5 years, except successfully treated basal-cell skin carcinoma and cervical tumors in situ;\n7. Severe abnormalities of liver and kidney functions (ALT≥2 times the upper limit of normal; Total bilirubin Tbil≥2 upper limit of normal; Creatinine Cr≥2 upper limit of normal);\n8. Metabolic disorders, including uncontrolled diabetes mellitus or fasting blood glucose ≥10mmol\u002FL, hypothyroidism, or hyperthyroidism;\n9. Receiving fat emulsion containing Omega-3 fatty acids, glutamine, thymosin, glucocorticoid, thyroxine, growth hormone, and anti-tumor necrosis factor biologic agents\n10. History of known allergy to any component of ORAL IMPACT®;\n11. Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test at baseline or not using a reliable and appropriate contraceptive method;\n12. Refuse to sign the consent or unable to follow the study protocol;\n13. Inappropriate to participate in this study judged by investigators.","ALL","18 Years","80 Years",{"count":247,"type":248},400,"ESTIMATED","INTERVENTIONAL",[251],"NA","This clinical trial aims to determine whether perioperative goal-directed nutritional therapy can prevent postoperative pulmonary and other major complications in malnourished esophageal squamous cell cancer patients. Its main question is whether individualized nutritional therapy can improve short-term surgical outcomes and long-term prognosis. Researchers will compare goal-directed and conventional nutritional therapy to identify differences in morbidities and survival.",[254],"Esophagus Cancer",[256,257,258,259,260,261],"Esophageal Cancer","Esophagectomy","Nutritional Therapy","Morbidity","Survival","Malnourished","2024-07-14",{"date":264,"type":265},"2024-07-19","ACTUAL",{"date":267,"type":265},"2024-03-30",{"date":269,"type":248},"2031-05-30",{"name":5,"class":6},17]