Clinical Investigation of Sympathetic Nerve Width Measurement in Thoracoscopic Sympathectomy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-55
SponsorTongji University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis : Confirmed autonomic nervous dysfunction (including palmar hyperhidrosis, craniofacial hyperhidrosis, or facial blushing).

Age : ≥18 years and ≤55 years.

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.

Disqualifiers

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.

ECG showing ST-segment elevation/depression, T-wave inversion.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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)
2

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
3

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
4

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.

Secondary outcomes

1

Operative Time

Duration of surgery measured from skin incision to final skin closure, recorded in minutes.

Time frame
Intraoperative (Day 0).
2

Intraoperative Blood Loss

Volume of blood lost during surgery, measured using suction canister collection and gauze weight difference.

Time frame
Intraoperative (Day 0).
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: