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Not yet recruiting NCT07047859

Clinical Investigation of Sympathetic Nerve Width Measurement in Thoracoscopic Sympathectomy

— Observational Thoracoscopic Sympathectomy (ETS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Thoracoscopic Sympathectomy (ETS). Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Primary outcome measures

  • Intraoperative Sympathetic Nerve Width [Time frame: Intraoperative (Day 0)]
  • Predictive Value of Nerve Width for Surgical Success [Time frame: through study completion, an average of 1 year]
  • Predictive Value of Nerve Width for Compensatory Hyperhidrosis [Time frame: through study completion, an average of 1 year]
  • Symptom Recurrence Rate [Time frame: 6/12 months post-op vs. 1-month baseline.]
  • Sustained Quality of Life Improvement [Time frame: 6/12 months post-op vs. 1-month baseline.]
  • Palmar/Forehead Temperature Change [Time frame: Baseline (pre-op), 1/3/6/12 months post-op.]
  • Patient Satisfaction [Time frame: 1/3/6/12 months post-op.]
  • Hyperhidrosis Disease Severity Scale (HDSS) Score [Time frame: 1/3/6/12 months post-op.]
  • Compensatory Hyperhidrosis Rate [Time frame: 1/3/6/12 months post-op.]
Secondary outcome measures (12)
  • Operative Time [Time frame: Intraoperative (Day 0).]
  • Intraoperative Blood Loss [Time frame: Intraoperative (Day 0).]
  • Resting Heart Rate [Time frame: Baseline (pre-op), 1/3/6/12 months post-op.]
  • Resting Blood Pressure [Time frame: Baseline (pre-op), 1/3/6/12 months post-op.]
  • Plasma Catecholamine Levels [Time frame: Baseline (pre-op), 1/3/6/12 months post-op.]
  • Blood Flow Velocity [Time frame: Baseline (pre-op), 1/3/6/12 months post-op.]
  • Serum Electrolyte Levels [Time frame: Baseline (pre-op), 1/3/6/12 months post-op.]
  • Liver Function Tests [Time frame: Baseline (pre-op), 1/3/6/12 months post-op.]
  • Kidney Function Tests [Time frame: Baseline (pre-op), 1/3/6/12 months post-op.]
  • White Blood Cell (WBC) Count [Time frame: Baseline (pre-op), 1/3/6/12 months post-op.]
  • Red Blood Cell (RBC) Count [Time frame: Baseline (pre-op), 1/3/6/12 months post-op.]
  • Platelet Count [Time frame: Baseline (pre-op), 1/3/6/12 months post-op.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Shanghai General Hospital Shanghai Jiao Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT07047859 · 20250228033833606

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗