An observational study in Thoracoscopic Sympathectomy (ETS), sponsored by Tongji University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-07-02.
Sponsored by Tongji University · Observational
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.
Tongji University is the lead sponsor of 40 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Cardiopulmonary Function :
Normal preoperative chest CT scan and (ECG).
Exclusion Criteria:
1. Abnormal Preoperative :
Severe arrhythmias:
Myocardial ischemia or infarction:
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:
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 : Allergy to anesthetics or high-risk conditions (severe pulmonary/cardiac dysfunction).
5. Cognitive/Psychiatric Impairment : Inability to provide 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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"
Time frame: 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.
Time frame: 1/3/6/12 months post-op.
Compensatory Hyperhidrosis Rate
Incidence (%) of clinically significant compensatory sweating (patient-reported or physician-confirmed).
Time frame: 1/3/6/12 months post-op.
Operative Time
Duration of surgery measured from skin incision to final skin closure, recorded in minutes.
Time frame: Intraoperative (Day 0).
Intraoperative Blood Loss
Volume of blood lost during surgery, measured using suction canister collection and gauze weight difference.
Time frame: 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).
Time frame: 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).
Time frame: Baseline (pre-op), 1/3/6/12 months post-op.
Plasma Catecholamine Levels
Quantification of dopamine, epinephrine, and norepinephrine levels in plasma.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (pre-op), 1/3/6/12 months post-op.
Liver Function Tests
Measurement of liver enzymes (ALT, AST) to assess potential organ toxicity.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (pre-op), 1/3/6/12 months post-op.
Platelet Count
Measurement of platelet count to evaluate clotting potential and risk of thrombocytopenia.
Time frame: Baseline (pre-op), 1/3/6/12 months post-op.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jul 2025; primary completion for May 2029, 46 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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