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Набор скоро начнётся NCT07047859

Clinical Investigation of Sympathetic Nerve Width Measurement in Thoracoscopic Sympathectomy

— Наблюдательное Thoracoscopic Sympathectomy (ETS)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Thoracoscopic Sympathectomy (ETS). Базовые параметры: 18 лет — 55 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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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)

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