Thoracoscopic Sympathectomy (ETS)
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Tongji University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis : Confirmed autonomic nervous dysfunction (including palmar hyperhidrosis, craniofacial hyperhidrosis, or facial blushing). 2. Age : ≥18 years and ≤55 years. 3. Cardiopulmonary Function : Normal preoperative chest CT scan and electrocardiogram (ECG). 4. Performance Status : ECOG score (see Attachment 1) of 0-1, indicating good clinical fitness and ability to perform daily activities independently. 5. 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.
Exclusion criteria
1\. Abnormal Preoperative ECG : 1. Severe arrhythmias: 1. Type II second-degree or higher atrioventricular block. 2. Symptomatic ventricular arrhythmias. 3. Uncontrolled supraventricular arrhythmias (resting heart rate \>100 bpm). These may cause inadequate cardiac output, hypoperfusion of vital organs, and increased surgical risk. 2. Myocardial ischemia or infarction: 1. ECG showing ST-segment elevation/depression, T-wave inversion. 2. Pathological Q-waves indicating myocardial infarction. 2. Abnormal Chest CT : 1\) 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. 2\) Pneumothorax or tension pneumothorax: 1. Significant lung collapse causing dyspnea. 2. Tension pneumothorax requiring immediate chest tube drainage. 3) Pleural effusion (moderate/large volume): Causes dyspnea or mediastinal shift; surgery may worsen respiratory function. 3\. Hyperthyroidism-induced facial blushing or generalized hyperhidrosis. 4. Anesthesia Contraindications : Allergy to anesthetics or high-risk conditions (severe pulmonary/cardiac dysfunction). 5\. Cognitive/Psychiatric Impairment : Inability to provide informed consent or understand study risks. 6\. Non-Compliance with Follow-up : Inability to adhere to postoperative visits. 7\. Immunodeficiency Disorders : Severe immunodeficiency, AIDS, or organ transplant history. 8\. Frailty/Advanced Age : Elderly patients with comorbidities or functional decline unfit for surgery. 9\. Severe Organ Dysfunction : Cirrhosis, renal failure, or inability to tolerate surgery/recovery. 10\. Active Infections : Under antibiotic treatment for pneumonia, tuberculosis, or bacterial infections. 11\. Uncontrolled Diabetes : Poor glycemic control with complications (retinopathy, diabetic foot). 12\. Concurrent Clinical Trials : Participation in other interventional studies affecting results. 13\. Severe Malnutrition : Significant weight loss or nutritional deficiency increasing anesthesia/surgical risks. 14\. Hematologic Disorders : Anemia, thrombocytopenia, or coagulopathies affecting hemostasis/recovery. 15\. Severe Chronic Respiratory Failure : Long-term ventilator dependence or tracheostomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Sympathetic Nerve Width | 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 | 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 | 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. |
| Symptom Recurrence Rate | 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. |
| Sustained Quality of Life Improvement | 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. |
| Palmar/Forehead Temperature Change | 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. |
| Patient Satisfaction | 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 | 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 | 1/3/6/12 months post-op. | Incidence (%) of clinically significant compensatory sweating (patient-reported or physician-confirmed). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| White Blood Cell (WBC) Count | Baseline (pre-op), 1/3/6/12 months post-op. | Measurement of white blood cell count to monitor for infection, inflammation. |
| Operative Time | Intraoperative (Day 0). | Duration of surgery measured from skin incision to final skin closure, recorded in minutes. |
| Platelet Count | Baseline (pre-op), 1/3/6/12 months post-op. | Measurement of platelet count to evaluate clotting potential and risk of thrombocytopenia. |
| Red Blood Cell (RBC) Count | Baseline (pre-op), 1/3/6/12 months post-op. | Measurement of red blood cell count to assess anemia risk. |
| Intraoperative Blood Loss | Intraoperative (Day 0). | Volume of blood lost during surgery, measured using suction canister collection and gauze weight difference. |
| Resting Heart Rate | Baseline (pre-op), 1/3/6/12 months post-op. | Measurement of resting heart rate (beats per minute) at baseline and postoperatively to assess autonomic function changes. Unit of Measure: Beats per minute (bpm). |
| Resting Blood Pressure | Baseline (pre-op), 1/3/6/12 months post-op. | Measurement of systolic and diastolic blood pressure (mmHg) at rest to evaluate hemodynamic changes. Unit of Measure: Millimeters of mercury (mmHg). |
| Plasma Catecholamine Levels | Baseline (pre-op), 1/3/6/12 months post-op. | Quantification of dopamine, epinephrine, and norepinephrine levels in plasma. |
| Blood Flow Velocity | Baseline (pre-op), 1/3/6/12 months post-op. | Doppler ultrasound-derived flow velocity (cm/s) in hands/forehead: Vm (Mean Velocity) = \[Peak Systolic (Vs) + 2×End-Diastolic (Vd)\] / 3. |
| Serum Electrolyte Levels | Baseline (pre-op), 1/3/6/12 months post-op. | Measurement of sodium (Na⁺), potassium (K⁺), and chloride (Cl-) levels in serum to monitor electrolyte balance. |
| Liver Function Tests | Baseline (pre-op), 1/3/6/12 months post-op. | Measurement of liver enzymes (ALT, AST) to assess potential organ toxicity. |
| Kidney Function Tests | Baseline (pre-op), 1/3/6/12 months post-op. | Measurement of kidney function markers (creatinine, BUN) to assess potential organ toxicity. |
Countries
China
Contacts
Primary ContactQiongliang Liu, Doctor
Outcome results
None listed