Clinical Investigation of Sympathetic Nerve Width Measurement in Thoracoscopic Sympathectomy

Обзор

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.

Первичные конечные точки

• Intraoperative Sympathetic Nerve Width [Срок оценки: Intraoperative (Day 0)]
• Predictive Value of Nerve Width for Surgical Success [Срок оценки: through study completion, an average of 1 year]
• Predictive Value of Nerve Width for Compensatory Hyperhidrosis [Срок оценки: through study completion, an average of 1 year]
• Symptom Recurrence Rate [Срок оценки: 6/12 months post-op vs. 1-month baseline.]
• Sustained Quality of Life Improvement [Срок оценки: 6/12 months post-op vs. 1-month baseline.]
• Palmar/Forehead Temperature Change [Срок оценки: Baseline (pre-op), 1/3/6/12 months post-op.]
• Patient Satisfaction [Срок оценки: 1/3/6/12 months post-op.]
• Hyperhidrosis Disease Severity Scale (HDSS) Score [Срок оценки: 1/3/6/12 months post-op.]
• Compensatory Hyperhidrosis Rate [Срок оценки: 1/3/6/12 months post-op.]

Вторичные конечные точки (12)

• Operative Time [Срок оценки: Intraoperative (Day 0).]
• Intraoperative Blood Loss [Срок оценки: Intraoperative (Day 0).]
• Resting Heart Rate [Срок оценки: Baseline (pre-op), 1/3/6/12 months post-op.]
• Resting Blood Pressure [Срок оценки: Baseline (pre-op), 1/3/6/12 months post-op.]
• Plasma Catecholamine Levels [Срок оценки: Baseline (pre-op), 1/3/6/12 months post-op.]
• Blood Flow Velocity [Срок оценки: Baseline (pre-op), 1/3/6/12 months post-op.]
• Serum Electrolyte Levels [Срок оценки: Baseline (pre-op), 1/3/6/12 months post-op.]
• Liver Function Tests [Срок оценки: Baseline (pre-op), 1/3/6/12 months post-op.]
• Kidney Function Tests [Срок оценки: Baseline (pre-op), 1/3/6/12 months post-op.]
• White Blood Cell (WBC) Count [Срок оценки: Baseline (pre-op), 1/3/6/12 months post-op.]
• Red Blood Cell (RBC) Count [Срок оценки: Baseline (pre-op), 1/3/6/12 months post-op.]
• Platelet Count [Срок оценки: Baseline (pre-op), 1/3/6/12 months post-op.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

1\. 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. 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:

• 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.

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Shanghai General Hospital Shanghai Jiao Tong University School of Medicine — Шанхай

Идентификаторы

NCT: NCT07047859 · 20250228033833606

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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