Clinical Investigation of Sympathetic Nerve Width Measurement in Thoracoscopic Sympathectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Intraoperative Sympathetic Nerve Width
研究概览
简要总结
This prospective, single-center observational study evaluates the clinical utility of intraoperative sympathetic nerve width measurement during thoracoscopic sympathectomy (ETS) for palmar/craniofacial hyperhidrosis (PH/CH) 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.
Approximately 1,000 patients (aged 18-55) will undergo standardized ETS at Shanghai First People's Hospital (2025-2029). Objective metrics include thermographic (palmar/forehead temperature), hemodynamic (HR/BP), biochemical (catecholamines), and Doppler flow measurements. Patient-reported outcomes use diagnosis-specific binary questionnaires and the Hyperhidrosis Disease Severity Scale (HDSS).
Statistical 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis : Confirmed autonomic nervous dysfunction (including palmar hyperhidrosis, craniofacial hyperhidrosis, or facial blushing).
- •Age : ≥18 years and ≤55 years.
- •Cardiopulmonary Function :
- •Normal preoperative chest CT scan and electrocardiogram (ECG).
- •Performance Status : ECOG score (see Attachment 1) of 0-1, indicating good clinical fitness and ability to perform daily activities independently.
- •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.
排除标准
- •Abnormal Preoperative ECG :
- •Severe arrhythmias:
- •Type II second-degree or higher atrioventricular block.
- •Symptomatic ventricular arrhythmias.
- •Uncontrolled supraventricular arrhythmias (resting heart rate >100 bpm). These may cause inadequate cardiac output, hypoperfusion of vital organs, and increased surgical risk.
- •Myocardial ischemia or infarction:
- •ECG showing ST-segment elevation/depression, T-wave inversion.
- •Pathological Q-waves indicating myocardial infarction.
- •Abnormal Chest CT :
- •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.
- •Pneumothorax or tension pneumothorax:
- •Significant lung collapse causing dyspnea.
- •Tension pneumothorax requiring immediate chest tube drainage. 3) Pleural effusion (moderate/large volume): Causes dyspnea or mediastinal shift; surgery may worsen respiratory function.
- •Hyperthyroidism-induced facial blushing or generalized hyperhidrosis.
- •Anesthesia Contraindications : Allergy to anesthetics or high-risk conditions (severe pulmonary/cardiac dysfunction).
- •Cognitive/Psychiatric Impairment : Inability to provide informed consent or understand study risks.
- •Non-Compliance with Follow-up : Inability to adhere to postoperative visits.
- •Immunodeficiency Disorders : Severe immunodeficiency, AIDS, or organ transplant history.
- •Frailty/Advanced Age : Elderly patients with comorbidities or functional decline unfit for surgery.
- •Severe Organ Dysfunction : Cirrhosis, renal failure, or inability to tolerate surgery/recovery.
- •Active Infections : Under antibiotic treatment for pneumonia, tuberculosis, or bacterial infections.
- •Uncontrolled Diabetes : Poor glycemic control with complications (retinopathy, diabetic foot).
- •Concurrent Clinical Trials : Participation in other interventional studies affecting results.
- •Severe Malnutrition : Significant weight loss or nutritional deficiency increasing anesthesia/surgical risks.
- •Hematologic Disorders : Anemia, thrombocytopenia, or coagulopathies affecting hemostasis/recovery.
- •Severe Chronic Respiratory Failure : Long-term ventilator dependence or tracheostomy.
结局指标
主要结局
Intraoperative Sympathetic Nerve Width
时间窗: Intraoperative (Day 0)
Quantitative measurement (mm) of thoracic sympathetic nerve trunks (T2 for craniofacial hyperhidrosis/facial 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.
Predictive Value of Nerve Width for Surgical Success
时间窗: through study completion, an average of 1 year
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.
Predictive Value of Nerve Width for Compensatory Hyperhidrosis
时间窗: through study completion, an average of 1 year
Assess whether intraoperative sympathetic nerve width (mm) predicts the incidence of clinically significant compensatory hyperhidrosis requiring intervention. Analysis Method: ROC curve analysis.
Sustained Quality of Life Improvement
时间窗: 6/12 months post-op vs. 1-month baseline.
Improvement in patient-reported quality of life scores, measured by validated questionnaires, compared to 1-month postoperative baseline.
Patient Satisfaction
时间窗: 1/3/6/12 months post-op.
Proportion of patients reporting improvement in social confidence, daily functioning, and symptom burden using binary (yes/no) responses from diagnosis-specific questionnaires. Unit of Measure: Percentage of patients responding "Yes"
Hyperhidrosis Disease Severity Scale (HDSS) Score
时间窗: 1/3/6/12 months post-op.
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.
Compensatory Hyperhidrosis Rate
时间窗: 1/3/6/12 months post-op.
Incidence (%) of clinically significant compensatory sweating (patient-reported or physician-confirmed).
Symptom Recurrence Rate
时间窗: 6/12 months post-op vs. 1-month baseline.
Proportion of patients reporting recurrence of primary symptoms (palmar hyperhidrosis, craniofacial hyperhidrosis, or facial blushing) at follow-up.
Palmar/Forehead Temperature Change
时间窗: Baseline (pre-op), 1/3/6/12 months post-op.
∆ Temperature (°C) pre- vs. post-surgery measured by standardized infrared thermometer. Reflects sympathetic denervation effect on peripheral circulation.
次要结局
- Blood Flow Velocity(Baseline (pre-op), 1/3/6/12 months post-op.)
- Resting Heart Rate(Baseline (pre-op), 1/3/6/12 months post-op.)
- Liver Function Tests(Baseline (pre-op), 1/3/6/12 months post-op.)
- Kidney Function Tests(Baseline (pre-op), 1/3/6/12 months post-op.)
- Operative Time(Intraoperative (Day 0).)
- Plasma Catecholamine Levels(Baseline (pre-op), 1/3/6/12 months post-op.)
- Serum Electrolyte Levels(Baseline (pre-op), 1/3/6/12 months post-op.)
- Intraoperative Blood Loss(Intraoperative (Day 0).)
- Resting Blood Pressure(Baseline (pre-op), 1/3/6/12 months post-op.)
- White Blood Cell (WBC) Count(Baseline (pre-op), 1/3/6/12 months post-op.)
- Red Blood Cell (RBC) Count(Baseline (pre-op), 1/3/6/12 months post-op.)
- Platelet Count(Baseline (pre-op), 1/3/6/12 months post-op.)
研究者
Jiang Fan
Professor
Tongji University