[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596622":3},{"organization":4,"outcomesModule":7,"designInfo":80,"detailedDescription":79,"studyPopulation":83,"armGroups":79,"interventions":79,"overallOfficials":84,"centralContacts":89,"locations":95,"responsibleParty":108,"collaborators":79,"id":111,"slug":79,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":79,"eligibilityCriteria":115,"healthyVolunteers":112,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":79,"studyType":122,"phases":79,"briefSummary":123,"conditions":124,"keywords":79,"overallStatus":126,"whyStopped":79,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Tongji University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":41,"otherOutcomes":79},[9,13,17,20,24,27,31,35,38],{"measure":10,"description":11,"timeFrame":12},"Intraoperative Sympathetic Nerve Width","Quantitative measurement (mm) of thoracic sympathetic nerve trunks (T2 for craniofacial hyperhidrosis\u002Ffacial blushing; T4 for facial blushing), using the Rapid Measurement System (RMSNW-OS). Measurement based on thoracoscopic image pixel ratios. Method: Calibrated electrosurgical hook with 5 mm reference; width calculated from still-frame images. Precision: ±0.2 mm.","Intraoperative (Day 0)",{"measure":14,"description":15,"timeFrame":16},"Predictive Value of Nerve Width for Surgical Success","Assess whether intraoperative sympathetic nerve width (mm) predicts surgical success, defined as ≥50% symptom reduction based on the Hyperhidrosis Disease Severity Scale (HDSS). Analysis Method: ROC curve analysis.","through study completion, an average of 1 year",{"measure":18,"description":19,"timeFrame":16},"Predictive Value of Nerve Width for Compensatory Hyperhidrosis","Assess whether intraoperative sympathetic nerve width (mm) predicts the incidence of clinically significant compensatory hyperhidrosis requiring intervention. Analysis Method: ROC curve analysis.",{"measure":21,"description":22,"timeFrame":23},"Symptom Recurrence Rate","Proportion of patients reporting recurrence of primary symptoms (palmar hyperhidrosis, craniofacial hyperhidrosis, or facial blushing) at follow-up.","6\u002F12 months post-op vs. 1-month baseline.",{"measure":25,"description":26,"timeFrame":23},"Sustained Quality of Life Improvement","Improvement in patient-reported quality of life scores, measured by validated questionnaires, compared to 1-month postoperative baseline.",{"measure":28,"description":29,"timeFrame":30},"Palmar\u002FForehead Temperature Change","∆ Temperature (°C) pre- vs. post-surgery measured by standardized infrared thermometer. Reflects sympathetic denervation effect on peripheral circulation.","Baseline (pre-op), 1\u002F3\u002F6\u002F12 months post-op.",{"measure":32,"description":33,"timeFrame":34},"Patient Satisfaction","Proportion of patients reporting improvement in social confidence, daily functioning, and symptom burden using binary (yes\u002Fno) responses from diagnosis-specific questionnaires. Unit of Measure: Percentage of patients responding \"Yes\"","1\u002F3\u002F6\u002F12 months post-op.",{"measure":36,"description":37,"timeFrame":34},"Hyperhidrosis Disease Severity Scale (HDSS) Score","Change in HDSS score (scale 1-4) to assess severity of hyperhidrosis and its impact on daily life. Unit of Measure: Units on a 4-point scale.",{"measure":39,"description":40,"timeFrame":34},"Compensatory Hyperhidrosis Rate","Incidence (%) of clinically significant compensatory sweating (patient-reported or physician-confirmed).",[42,46,49,52,55,58,61,64,67,70,73,76],{"measure":43,"description":44,"timeFrame":45},"Operative Time","Duration of surgery measured from skin incision to final skin closure, recorded in minutes.","Intraoperative (Day 0).",{"measure":47,"description":48,"timeFrame":45},"Intraoperative Blood Loss","Volume of blood lost during surgery, measured using suction canister collection and gauze weight difference.",{"measure":50,"description":51,"timeFrame":30},"Resting Heart Rate","Measurement of resting heart rate (beats per minute) at baseline and postoperatively to assess autonomic function changes. Unit of Measure: Beats per minute (bpm).",{"measure":53,"description":54,"timeFrame":30},"Resting Blood Pressure","Measurement of systolic and diastolic blood pressure (mmHg) at rest to evaluate hemodynamic changes. Unit of Measure: Millimeters of mercury (mmHg).",{"measure":56,"description":57,"timeFrame":30},"Plasma Catecholamine Levels","Quantification of dopamine, epinephrine, and norepinephrine levels in plasma.",{"measure":59,"description":60,"timeFrame":30},"Blood Flow Velocity","Doppler ultrasound-derived flow velocity (cm\u002Fs) in hands\u002Fforehead:\n\nVm (Mean Velocity) = \\[Peak Systolic (Vs) + 2×End-Diastolic (Vd)\\] \u002F 3.",{"measure":62,"description":63,"timeFrame":30},"Serum Electrolyte Levels","Measurement of sodium (Na⁺), potassium (K⁺), and chloride (Cl-) levels in serum to monitor electrolyte balance.",{"measure":65,"description":66,"timeFrame":30},"Liver Function Tests","Measurement of liver enzymes (ALT, AST) to assess potential organ toxicity.",{"measure":68,"description":69,"timeFrame":30},"Kidney Function Tests","Measurement of kidney function markers (creatinine, BUN) to assess potential organ toxicity.",{"measure":71,"description":72,"timeFrame":30},"White Blood Cell (WBC) Count","Measurement of white blood cell count to monitor for infection, inflammation.",{"measure":74,"description":75,"timeFrame":30},"Red Blood Cell (RBC) Count","Measurement of red blood cell count to assess anemia risk.",{"measure":77,"description":78,"timeFrame":30},"Platelet Count","Measurement of platelet count to evaluate clotting potential and risk of thrombocytopenia.",null,{"allocation":79,"interventionModel":79,"interventionModelDescription":79,"primaryPurpose":79,"observationalModel":81,"timePerspective":82,"maskingInfo":79},"COHORT","PROSPECTIVE","Target Cohort : Adults (18-55 years) diagnosed with primary autonomic dysfunction disorders eligible for thoracoscopic sympathectomy (ETS):\n\nPalmar Hyperhidrosis (PH) : Excessive sweating of the hands. Craniofacial Hyperhidrosis (CH) : Excessive sweating of the head\u002Fface. Facial Blushing (FF) : Uncontrolled facial erythema.",[85],{"name":86,"affiliation":87,"role":88},"Xiao Zhou, Doctor","Shanghai General Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, Hongkou Distri 200080","PRINCIPAL_INVESTIGATOR",[90],{"name":91,"role":92,"phone":93,"phoneExt":79,"email":94},"Qiongliang Liu, Doctor","CONTACT","+8618117496385","qiongliang.liu@shgh.cn",[96],{"facility":97,"status":79,"city":98,"state":79,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":107,"contacts":79},"Shanghai General Hospital Shanghai Jiao Tong University School of Medicine","Shanghai","Hongkou Distri 200080","China","CN",{"type":103,"coordinates":104},"Point",[105,106],121.45806,31.22222,{"lat":106,"lon":105},{"type":88,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":79,"oldOrganization":79},"Jiang Fan","Professor","100596622",false,"NCT07047859","Clinical Investigation of Sympathetic Nerve Width Measurement in Thoracoscopic Sympathectomy","Inclusion Criteria:\n\n1. Diagnosis : Confirmed autonomic nervous dysfunction (including palmar hyperhidrosis, craniofacial hyperhidrosis, or facial blushing).\n2. Age : ≥18 years and ≤55 years.\n3. Cardiopulmonary Function :\n\n   Normal preoperative chest CT scan and electrocardiogram (ECG).\n4. Performance Status : ECOG score (see Attachment 1) of 0-1, indicating good clinical fitness and ability to perform daily activities independently.\n5. Informed Consent : Patients and their families fully understand the study's purpose, procedures, risks, and potential benefits, voluntarily sign the Informed Consent Form, and agree to participate.\n\nExclusion Criteria:\n\n1\\. Abnormal Preoperative ECG :\n\n1. Severe arrhythmias:\n\n   1. Type II second-degree or higher atrioventricular block.\n   2. Symptomatic ventricular arrhythmias.\n   3. Uncontrolled supraventricular arrhythmias (resting heart rate \\>100 bpm). These may cause inadequate cardiac output, hypoperfusion of vital organs, and increased surgical risk.\n2. Myocardial ischemia or infarction:\n\n   1. ECG showing ST-segment elevation\u002Fdepression, T-wave inversion.\n   2. Pathological Q-waves indicating myocardial infarction. 2. Abnormal Chest CT :\n\n1\\) Severe pulmonary infections (e.g., lobar pneumonia, empyema) with symptoms like fever, cough, dyspnea. Surgery increases infection risk and may lead to atelectasis or respiratory failure.\n\n2\\) Pneumothorax or tension pneumothorax:\n\n1. Significant lung collapse causing dyspnea.\n2. Tension pneumothorax requiring immediate chest tube drainage. 3) Pleural effusion (moderate\u002Flarge volume): Causes dyspnea or mediastinal shift; surgery may worsen respiratory function.\n\n   3\\. Hyperthyroidism-induced facial blushing or generalized hyperhidrosis. 4. Anesthesia Contraindications : Allergy to anesthetics or high-risk conditions (severe pulmonary\u002Fcardiac dysfunction).\n\n   5\\. Cognitive\u002FPsychiatric Impairment : Inability to provide informed consent or understand study risks.\n\n   6\\. Non-Compliance with Follow-up : Inability to adhere to postoperative visits.\n\n   7\\. Immunodeficiency Disorders : Severe immunodeficiency, AIDS, or organ transplant history.\n\n   8\\. Frailty\u002FAdvanced Age : Elderly patients with comorbidities or functional decline unfit for surgery.\n\n   9\\. Severe Organ Dysfunction : Cirrhosis, renal failure, or inability to tolerate surgery\u002Frecovery.\n\n   10\\. Active Infections : Under antibiotic treatment for pneumonia, tuberculosis, or bacterial infections.\n\n   11\\. Uncontrolled Diabetes : Poor glycemic control with complications (retinopathy, diabetic foot).\n\n   12\\. Concurrent Clinical Trials : Participation in other interventional studies affecting results.\n\n   13\\. Severe Malnutrition : Significant weight loss or nutritional deficiency increasing anesthesia\u002Fsurgical risks.\n\n   14\\. Hematologic Disorders : Anemia, thrombocytopenia, or coagulopathies affecting hemostasis\u002Frecovery.\n\n   15\\. Severe Chronic Respiratory Failure : Long-term ventilator dependence or tracheostomy.","ALL","18 Years","55 Years",{"count":120,"type":121},1000,"ESTIMATED","OBSERVATIONAL","This prospective, single-center observational study evaluates the clinical utility of intraoperative sympathetic nerve width measurement during thoracoscopic sympathectomy (ETS) for palmar\u002Fcraniofacial hyperhidrosis (PH\u002FCH) and facial blushing (FF). The study aims to correlate nerve width-measured using a novel Rapid Intraoperative Sympathetic Nerve Width System (RMSNW-OS) (±0.2mm precision)-with surgical outcomes, compensatory sweating rates, patient satisfaction, and 12-month efficacy.\n\nApproximately 1,000 patients (aged 18-55) will undergo standardized ETS at Shanghai First People's Hospital (2025-2029). Objective metrics include thermographic (palmar\u002Fforehead temperature), hemodynamic (HR\u002FBP), biochemical (catecholamines), and Doppler flow measurements. Patient-reported outcomes use diagnosis-specific binary questionnaires and the Hyperhidrosis Disease Severity Scale (HDSS).\n\nStatistical analysis will determine if nerve width predicts treatment response. Innovations include RMSNW-OS standardization and a multidimensional assessment framework to optimize ETS precision and patient quality of life.",[125],"Thoracoscopic Sympathectomy (ETS)","NOT_YET_RECRUITING","2025-06-30",{"date":129,"type":130},"2025-07-02","ACTUAL",{"date":132,"type":121},"2025-07-15",{"date":134,"type":121},"2029-05-31",{"name":5,"class":6},1]