[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634446":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":158,"collaborators":160,"id":174,"slug":175,"hasResults":176,"nctId":177,"briefTitle":178,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":176,"sex":181,"minAge":182,"maxAge":183,"enrollmentInfo":184,"targetDuration":18,"studyType":187,"phases":188,"briefSummary":190,"conditions":191,"keywords":195,"overallStatus":85,"whyStopped":18,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":208},{"fullName":5,"class":6},"Nanfang Hospital, Southern Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard skull base reconstruction plus the absorbable and moldable skull base support plate","EXPERIMENTAL","The intervention is performed during the skull base repair phase of the surgery. The sellar floor repair and reconstruction technique used in this study generally follows the multi-layer reconstruction and repair technique widely adopted in the classic endoscopic endonasal transsphenoidal approach :\n\nAssess the intraoperative grade of cerebrospinal fluid (CSF) leakage (Esposito classification).\n\nObliterate the tumor cavity: After tumor resection, the subarachnoid space and sellar cavity are usually packed with gelatin sponge (or autologous fat in a minority of patients, etc.).\n\nRepair the dura mater: Perform routine inlay repair with an impermeable artificial biomembrane to restore the dural layer.\n\nTrimming, shaping, and placement of the skull base support plate. Covering with mucosa: Cover the outer surface of the support plate with a pedicled or free nasal septal mucosal flap, and pack and stabilize it with gelatin sponge",[13],"Device: Absorbable and moldable skull base support plate",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard skull base reconstruction protocol","NO_INTERVENTION","No intervention is performed during the skull base repair phase of the surgery. The sellar floor repair and reconstruction technique used in this study generally follows the multi-layer reconstruction and repair technique widely adopted in the classic endoscopic endonasal transsphenoidal approach : Assess the intraoperative grade of cerebrospinal fluid (CSF) leakage (Esposito classification). Obliterate the tumor cavity: After tumor resection, the subarachnoid space and sellar cavity are usually packed with gelatin sponge (or autologous fat in a minority of patients, etc.). Repair the dura mater: Perform routine inlay repair with an impermeable artificial biomembrane to restore the dural layer. Cover with mucosa: Cover the outer surface of the dural layer with a pedicled or free nasal septal mucosal flap, and pack and stabilize it with gelatin sponge",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Absorbable and moldable skull base support plate","The sbsorbable and moldable skull base support plate is used during the skull base repair phase of the surgery.\n\nTrimming: Measure the size of the skull base defect bone window (from the tuberculum sellae to the clival bone edge). Cut the malleable support plate slightly longer than this dimension.\n\nShaping: Shape the plate according to the morphological changes of the sellar floor bone resulting from the lesion. In cases with no obvious sellar floor bone destruction (e.g., suprasellar craniopharyngioma), the support plate is shaped into a slight \"S\" curve to ensure tight apposition to the dural window and the inlay artificial dura, preventing the formation of intervening gaps.\n\nPlacement: Since the support plate requires tight embedding under the anterior and posterior bone edges, bone edges at the tuberculum sellae and clivus should be preserved during sellar floor drilling according to surgical exposure and plate embedding requirements to facilitate secure fixation.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Jun Pan MD, Ph.D","CONTACT","+86-13076878155","1448875873@qq.com",[32,52,67,83,104,115,129,143],{"facility":33,"status":34,"city":35,"state":36,"zip":18,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"The First People's Hospital Of Foshan","NOT_YET_RECRUITING","Foshan","Guangdong","China","CN",{"type":40,"coordinates":41},"Point",[42,43],113.13148,23.02677,{"lat":43,"lon":42},[46,50],{"name":47,"role":28,"phone":48,"phoneExt":18,"email":49},"Lianxu Cui","+86-18038863001","cuilianxu@qq.com",{"name":47,"role":51,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"facility":53,"status":34,"city":54,"state":36,"zip":18,"country":37,"countryCode":38,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Gaozhou People's Hospital","Gaozhou",{"type":40,"coordinates":56},[57,58],110.85678,21.91965,{"lat":58,"lon":57},[61,64,66],{"name":62,"role":28,"phone":63,"phoneExt":18,"email":18},"Linfan Li","+86-138 2488 0022",{"name":18,"role":28,"phone":18,"phoneExt":18,"email":65},"lmj1006@yeah.net",{"name":62,"role":51,"phone":18,"phoneExt":18,"email":18},{"facility":68,"status":34,"city":69,"state":36,"zip":70,"country":37,"countryCode":38,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Sun Yat-sen University Cancer Center","Guangzhou","510060",{"type":40,"coordinates":72},[73,74],113.25,23.11667,{"lat":74,"lon":73},[77,81],{"name":78,"role":28,"phone":79,"phoneExt":18,"email":80},"Xiaobing Jiang, MD, Ph.D","+86-15201253009","jiangxiaob1@sysucc.org.cn",{"name":82,"role":51,"phone":18,"phoneExt":18,"email":18},"XIaobing Jiang, MD, Ph.D",{"facility":84,"status":85,"city":69,"state":36,"zip":86,"country":37,"countryCode":38,"cosmosGeoPoint":87,"geoPoint":89,"contacts":90},"Southern Medical University, Nanfang Hospital, Department of Neurosurgery","RECRUITING","510515",{"type":40,"coordinates":88},[73,74],{"lat":74,"lon":73},[91,93,96,98,100,102],{"name":92,"role":51,"phone":18,"phoneExt":18,"email":18},"Jun Pan, MD, Ph.D",{"name":94,"role":95,"phone":18,"phoneExt":18,"email":18},"Mingfeng Zhou, Ph.D","SUB_INVESTIGATOR",{"name":97,"role":95,"phone":18,"phoneExt":18,"email":18},"Jing Nie, Ph.D",{"name":99,"role":95,"phone":18,"phoneExt":18,"email":18},"Junxiang Peng, Ph.D",{"name":101,"role":95,"phone":18,"phoneExt":18,"email":18},"Jian Mao, Ph.D",{"name":103,"role":95,"phone":18,"phoneExt":18,"email":18},"Yilamujiang Ainiwan, Ph.D",{"facility":105,"status":34,"city":69,"state":36,"zip":18,"country":37,"countryCode":38,"cosmosGeoPoint":106,"geoPoint":108,"contacts":109},"Guangdong Provincial Hospital of Traditional Chinese Medicine",{"type":40,"coordinates":107},[73,74],{"lat":74,"lon":73},[110,114],{"name":111,"role":28,"phone":112,"phoneExt":18,"email":113},"Tao Huang","+86-18688898958","arteries@163.com",{"name":111,"role":51,"phone":18,"phoneExt":18,"email":18},{"facility":116,"status":34,"city":117,"state":36,"zip":18,"country":37,"countryCode":38,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Huizhou Central People's Hospital","Huizhou",{"type":40,"coordinates":119},[120,121],114.41523,23.11147,{"lat":121,"lon":120},[124,128],{"name":125,"role":28,"phone":126,"phoneExt":18,"email":127},"Honghai Luo, Master of Medical Science","+86-15820717999","luohonghai999@sohu.com",{"name":125,"role":51,"phone":18,"phoneExt":18,"email":18},{"facility":130,"status":34,"city":131,"state":36,"zip":18,"country":37,"countryCode":38,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"The First People's Hospital of Zhaoqing","Zhaoqing",{"type":40,"coordinates":133},[134,135],112.46091,23.04893,{"lat":135,"lon":134},[138,142],{"name":139,"role":28,"phone":140,"phoneExt":18,"email":141},"Haibin Li","+86-13560917978","Lihaibin08@126.com",{"name":139,"role":51,"phone":18,"phoneExt":18,"email":18},{"facility":144,"status":34,"city":145,"state":146,"zip":18,"country":37,"countryCode":38,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Liuzhou people's hospital","Liuzhou","Guangxi",{"type":40,"coordinates":148},[149,150],109.40698,24.32405,{"lat":150,"lon":149},[153,157],{"name":154,"role":28,"phone":155,"phoneExt":18,"email":156},"Yuanliang Ye","+86-13667726163","yeyuanliangy@163.com",{"name":154,"role":51,"phone":18,"phoneExt":18,"email":18},{"type":159,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[161,163,165,166,168,170,172],{"name":162,"class":6},"First People's Hospital of Zhaoqing",{"name":164,"class":6},"Sun Yat-Sen University Cancer Center",{"name":105,"class":6},{"name":167,"class":6},"The People's Hospital of Gaozhou",{"name":169,"class":6},"First People's Hospital of Foshan",{"name":171,"class":6},"Huizhou Municipal Central Hospital",{"name":173,"class":6},"LiuZhou People's Hospital","100634446","phase-2-efficacy-and-safety-evaluation-of-absorbable-and-moldable-skull-base-support-plates-in-extended-endoscopic-endonasal-transsphenoidal-surgery-a-prospective-randomized-controlled-study-100634446",false,"NCT07539792","Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study","EEEA-AMSBP","Inclusion Criteria:\n\n1. Aged 1-80 years, regardless of gender;\n2. Diagnosed with sellar region tumors confirmed by clinical symptoms, endocrine examinations, and imaging data;\n3. Planned to undergo extended endoscopic endonasal transsphenoidal approach surgery as determined by departmental discussion;\n4. Karnofsky Performance Status score ≥ 70, with an expected survival period ≥ 24 months;\n5. Laboratory indicators (such as liver and kidney function, blood routine, etc.) within the normal range or controllable range;\n6. Sign the informed consent form and are willing to participate in the study.\n\nExclusion Criteria:\n\n1. Patients with other concurrent intracranial tumors or severe brain lesions;\n2. Patients scheduled to undergo craniotomy or non-extended endoscopic endonasal transsphenoidal surgery;\n3. Patients with uncontrolled severe heart, lung, kidney, or liver diseases;\n4. Pregnant or lactating women;\n5. Patients who have previously received radiotherapy or chemotherapy;\n6. Patients with active nasal infections, inflammation, or severe nasal diseases;\n7. Patients with a history of severe allergies to drugs or synthetic materials;\n8. Patients with extensive skull base bone destruction evaluated by preoperative imaging, for whom it is estimated that support materials cannot be used during surgery;\n9. Patients with mental illness or cognitive impairment who are unable to complete follow-up or understand the purpose of the study.","ALL","1 Year","80 Years",{"count":185,"type":186},126,"ESTIMATED","INTERVENTIONAL",[189],"PHASE2","Primary objective: To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the incidence of cerebrospinal fluid (CSF) rhinorrhea within 1 month after surgery.\n\nSecondary objectives:\n\n1. To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the incidence of intracranial infection within 1 months after surgery;\n2. To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the duration of the surgery and length of postoperative hospital stay;\n3. To monitor and evaluate the safety of absorbable and moldable skull base support plates, especially the occurrence of nasal complications.",[192,193,194],"Sellar Tumor","Endonasal Surgery","Csf Leakage",[192,196,197,198],"Extended Endoscopic Endonasal Transsphenoidal Surgery","Cerebrospinal Fluid Rhinorrhea","Skull Base Reconstruction","2026-04-13",{"date":201,"type":202},"2026-04-20","ACTUAL",{"date":204,"type":202},"2026-04-01",{"date":206,"type":186},"2030-02-28",{"name":5,"class":6},8]