Clinical Investigation of Sympathetic Nerve Width Measurement in Thoracoscopic Sympathectomy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Thoracoscopic Sympathectomy (ETS)

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Qiongliang Liu, Doctor; Phone Number: +8618117496385; Email: qiongliang.liu@shgh.cn

Study Locations

• China
  • Shanghai, China, Hongkou Distri 200080
    • Shanghai General Hospital shanghai jiao tong university school of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Target Cohort : Adults (18-55 years) diagnosed with primary autonomic dysfunction disorders eligible for thoracoscopic sympathectomy (ETS):

Palmar Hyperhidrosis (PH) : Excessive sweating of the hands. Craniofacial Hyperhidrosis (CH) : Excessive sweating of the head/face. Facial Blushing (FF) : Uncontrolled facial erythema.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Sympathetic Nerve Width	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.	Intraoperative (Day 0)
Predictive Value of Nerve Width for Surgical Success	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.	through study completion, an average of 1 year
Predictive Value of Nerve Width for Compensatory Hyperhidrosis	Assess whether intraoperative sympathetic nerve width (mm) predicts the incidence of clinically significant compensatory hyperhidrosis requiring intervention. Analysis Method: ROC curve analysis.	through study completion, an average of 1 year
Symptom Recurrence Rate	Proportion of patients reporting recurrence of primary symptoms (palmar hyperhidrosis, craniofacial hyperhidrosis, or facial blushing) at follow-up.	6/12 months post-op vs. 1-month baseline.
Sustained Quality of Life Improvement	Improvement in patient-reported quality of life scores, measured by validated questionnaires, compared to 1-month postoperative baseline.	6/12 months post-op vs. 1-month baseline.
Palmar/Forehead Temperature Change	∆ Temperature (°C) pre- vs. post-surgery measured by standardized infrared thermometer. Reflects sympathetic denervation effect on peripheral circulation.	Baseline (pre-op), 1/3/6/12 months post-op.
Patient Satisfaction	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"	1/3/6/12 months post-op.
Hyperhidrosis Disease Severity Scale (HDSS) Score	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.	1/3/6/12 months post-op.
Compensatory Hyperhidrosis Rate	Incidence (%) of clinically significant compensatory sweating (patient-reported or physician-confirmed).	1/3/6/12 months post-op.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Time	Duration of surgery measured from skin incision to final skin closure, recorded in minutes.	Intraoperative (Day 0).
Intraoperative Blood Loss	Volume of blood lost during surgery, measured using suction canister collection and gauze weight difference.	Intraoperative (Day 0).
Resting Heart Rate	Measurement of resting heart rate (beats per minute) at baseline and postoperatively to assess autonomic function changes. Unit of Measure: Beats per minute (bpm).	Baseline (pre-op), 1/3/6/12 months post-op.
Resting Blood Pressure	Measurement of systolic and diastolic blood pressure (mmHg) at rest to evaluate hemodynamic changes. Unit of Measure: Millimeters of mercury (mmHg).	Baseline (pre-op), 1/3/6/12 months post-op.
Plasma Catecholamine Levels	Quantification of dopamine, epinephrine, and norepinephrine levels in plasma.	Baseline (pre-op), 1/3/6/12 months post-op.
Blood Flow Velocity	Doppler ultrasound-derived flow velocity (cm/s) in hands/forehead: Vm (Mean Velocity) = [Peak Systolic (Vs) + 2×End-Diastolic (Vd)] / 3.	Baseline (pre-op), 1/3/6/12 months post-op.
Serum Electrolyte Levels	Measurement of sodium (Na⁺), potassium (K⁺), and chloride (Cl-) levels in serum to monitor electrolyte balance.	Baseline (pre-op), 1/3/6/12 months post-op.
Liver Function Tests	Measurement of liver enzymes (ALT, AST) to assess potential organ toxicity.	Baseline (pre-op), 1/3/6/12 months post-op.
Kidney Function Tests	Measurement of kidney function markers (creatinine, BUN) to assess potential organ toxicity.	Baseline (pre-op), 1/3/6/12 months post-op.
White Blood Cell (WBC) Count	Measurement of white blood cell count to monitor for infection, inflammation.	Baseline (pre-op), 1/3/6/12 months post-op.
Red Blood Cell (RBC) Count	Measurement of red blood cell count to assess anemia risk.	Baseline (pre-op), 1/3/6/12 months post-op.
Platelet Count	Measurement of platelet count to evaluate clotting potential and risk of thrombocytopenia.	Baseline (pre-op), 1/3/6/12 months post-op.

Collaborators and Investigators

• Sponsor: Tongji University
• Investigators: Principal Investigator: Xiao Zhou, Doctor, Shanghai General Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, Hongkou Distri 200080

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029

Study Registration Dates

• First Submitted: June 8, 2025
• First Submitted That Met QC Criteria: June 30, 2025
• First Posted (Actual): July 2, 2025

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 20250228033833606

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No