[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sellar-tumor\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sellar-tumor":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"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":20,"type":21},126,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Sellar Tumor","Endonasal Surgery","Csf Leakage",[27,31,32,33],"Extended Endoscopic Endonasal Transsphenoidal Surgery","Cerebrospinal Fluid Rhinorrhea","Skull Base Reconstruction","RECRUITING","2026-04-13",{"date":37,"type":38},"2026-04-20","ACTUAL",{"date":40,"type":38},"2026-04-01",{"date":42,"type":21},"2030-02-28",{"name":44,"class":45},"Nanfang Hospital, Southern Medical University","OTHER",8,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100554168","optic-nerve-stimulation-to-prevent-visual-deficits-after-endoscopic-cranial-approaches-100554168","NCT06495580","Optic Nerve Stimulation To Prevent Visual Deficits After Endoscopic Cranial Approaches","Optimizing Visual Outcomes: Use of Optic Nerve Stimulation in Endoscopic Cranial Approaches","Inclusion Criteria:\n\n* Patients diagnosed with suprasellar tumors including meningiomas, craniopharyngiomas and pituitary adenomas.\n* Must not present with any permanent or temporal visual deficit.\n* Must receive an open or endoscopic endonasal procedure as part of their care.\n\nExclusion Criteria:\n\n* Preexisting visual impairments unrelated to the tumor.\n* History of prior cranial surgeries or radiation therapy.\n* Significant cognitive impairment or inability to provide informed consent\n* Contraindications to microstimulation procedures such as uncontrolled coagulopathy or active infection.\n* Patients with tumors located outside the sellar region or those requiring emergent or urgent surgery due to life-threatening complications.\n* Additionally, individuals with systemic conditions or comorbidities that may significantly impact visual function or surgical outcomes, such as uncontrolled diabetes mellitus or severe cardiovascular disease.","18 Years",{"count":56,"type":21},20,[58],"NA","Assessing the function of the optic nerve is paramount during various neurosurgical procedures. Effective optic nerve monitoring has remained elusive as Visual Evoked Potentials (the current existing tool) provides only diffuse and delayed assessment of nerve function. Here, the investigators propose a prospective study involving adult patients (aged 18 years and older) undergoing endonasal or open cranial approaches around the optic nerves, who will receive pre- and post-operative visual evaluations. During surgery, the optic nerve and chiasm will be stimulated, and the response will be recorded in both eyes and the occipital cortex via skin electrodes. The investigators aim to utilize anterograde optic nerve microstimulation to assess the nerve's integrity during open and endoscopic cranial approaches. Electrophysiological readings will be acquired, as is routine in the operating room, by our team of experts, and intraoperative findings will be correlated with post- surgical clinical outcomes. Our objective is to utilize existing technology in the operating room to safely and effectively monitor optic nerve function during surgery.",[61,27,62],"Optic Nerve Injuries","Skull Base Neoplasms","NOT_YET_RECRUITING","2024-07-10",{"date":66,"type":38},"2024-07-12",{"date":68,"type":21},"2024-08",{"date":70,"type":21},"2026-12",{"name":72,"class":45},"University of California, San Francisco",1]