Thoracoscopic Sympathectomy (ETS)NCT07047859
Clinical Investigation of Sympathetic Nerve Width Measurement in Thoracoscopic Sympathectomy
An observational study of Thoracoscopic Sympathectomy (ETS), run by Tongji University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Thoracoscopic Sympathectomy (ETS)
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2025to 31 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai General Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Hongkou Distri 200080
About this study
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.
- Conditions
- Thoracoscopic Sympathectomy (ETS)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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"
Measured: 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.
Measured: 1/3/6/12 months post-op.
Compensatory Hyperhidrosis Rate
Incidence (%) of clinically significant compensatory sweating (patient-reported or physician-confirmed).
Measured: 1/3/6/12 months post-op.
Secondary outcomes (12)
Operative Time
Duration of surgery measured from skin incision to final skin closure, recorded in minutes.
Measured: Intraoperative (Day 0).
Intraoperative Blood Loss
Volume of blood lost during surgery, measured using suction canister collection and gauze weight difference.
Measured: 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).
Measured: 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).
Measured: Baseline (pre-op), 1/3/6/12 months post-op.
Plasma Catecholamine Levels
Quantification of dopamine, epinephrine, and norepinephrine levels in plasma.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-op), 1/3/6/12 months post-op.
Liver Function Tests
Measurement of liver enzymes (ALT, AST) to assess potential organ toxicity.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-op), 1/3/6/12 months post-op.
Platelet Count
Measurement of platelet count to evaluate clotting potential and risk of thrombocytopenia.
Measured: Baseline (pre-op), 1/3/6/12 months post-op.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracoscopic Sympathectomy (ETS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiang Fan, Tongji University
- Investigators
- Xiao Zhou, Doctor, Principal investigator, Shanghai General Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, Hongkou Distri 200080
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047859
- Sponsor's protocol ID
- 20250228033833606
- Status last verified
- Jun 2025
- First submitted
- 8 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of Sympathetic Nerve Width Measurement in Thoracoscopic Sympathectomy
- ClinicalTrials.gov ID
- NCT07047859
- Acronym / sponsor ID
- 20250228033833606
- Conditions
- Thoracoscopic Sympathectomy (ETS)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intraoperative Sympathetic Nerve Width
Time frame: Intraoperative (Day 0)
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.
Predictive Value of Nerve Width for Surgical Success
Time frame: through study completion, an average of 1 year
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.
Predictive Value of Nerve Width for Compensatory Hyperhidrosis
Time frame: through study completion, an average of 1 year
Assess whether intraoperative sympathetic nerve width (mm) predicts the incidence of clinically significant compensatory hyperhidrosis requiring intervention. Analysis Method: ROC curve analysis.
Symptom Recurrence Rate
Time frame: 6/12 months post-op vs. 1-month baseline.
Proportion of patients reporting recurrence of primary symptoms (palmar hyperhidrosis, craniofacial hyperhidrosis, or facial blushing) at follow-up.
Sustained Quality of Life Improvement
Time frame: 6/12 months post-op vs. 1-month baseline.
Improvement in patient-reported quality of life scores, measured by validated questionnaires, compared to 1-month postoperative baseline.
Palmar/Forehead Temperature Change
Time frame: Baseline (pre-op), 1/3/6/12 months post-op.
∆ Temperature (°C) pre- vs. post-surgery measured by standardized infrared thermometer. Reflects sympathetic denervation effect on peripheral circulation.
Patient Satisfaction
Time frame: 1/3/6/12 months post-op.
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"
Hyperhidrosis Disease Severity Scale (HDSS) Score
Time frame: 1/3/6/12 months post-op.
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.
Compensatory Hyperhidrosis Rate
Time frame: 1/3/6/12 months post-op.
Incidence (%) of clinically significant compensatory sweating (patient-reported or physician-confirmed).
12 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiao Zhou, Doctor principal investigator
Shanghai General Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, Hongkou Distri 200080
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracoscopic Sympathectomy (ETS), run by Tongji University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qiongliang Liu, Doctor (+8618117496385, qiongliang.liu@shgh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Sympathetic Nerve Width (time frame: Intraoperative (Day 0)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.