Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-01-01 @ 11:26 AM
Study NCT ID:
NCT07047859
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-02
First Post:
2025-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Investigation of Sympathetic Nerve Width Measurement in Thoracoscopic Sympathectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2029-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2025-06-08', 'studyFirstSubmitQcDate': '2025-06-30', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative Sympathetic Nerve Width', 'timeFrame': 'Intraoperative (Day 0)', 'description': '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.'}, {'measure': 'Predictive Value of Nerve Width for Surgical Success', 'timeFrame': 'through study completion, an average of 1 year', 'description': '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.'}, {'measure': 'Predictive Value of Nerve Width for Compensatory Hyperhidrosis', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Assess whether intraoperative sympathetic nerve width (mm) predicts the incidence of clinically significant compensatory hyperhidrosis requiring intervention. Analysis Method: ROC curve analysis.'}, {'measure': 'Symptom Recurrence Rate', 'timeFrame': '6/12 months post-op vs. 1-month baseline.', 'description': 'Proportion of patients reporting recurrence of primary symptoms (palmar hyperhidrosis, craniofacial hyperhidrosis, or facial blushing) at follow-up.'}, {'measure': 'Sustained Quality of Life Improvement', 'timeFrame': '6/12 months post-op vs. 1-month baseline.', 'description': 'Improvement in patient-reported quality of life scores, measured by validated questionnaires, compared to 1-month postoperative baseline.'}, {'measure': 'Palmar/Forehead Temperature Change', 'timeFrame': 'Baseline (pre-op), 1/3/6/12 months post-op.', 'description': '∆ Temperature (°C) pre- vs. post-surgery measured by standardized infrared thermometer. Reflects sympathetic denervation effect on peripheral circulation.'}, {'measure': 'Patient Satisfaction', 'timeFrame': '1/3/6/12 months post-op.', 'description': '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"'}, {'measure': 'Hyperhidrosis Disease Severity Scale (HDSS) Score', 'timeFrame': '1/3/6/12 months post-op.', 'description': '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.'}, {'measure': 'Compensatory Hyperhidrosis Rate', 'timeFrame': '1/3/6/12 months post-op.', 'description': 'Incidence (%) of clinically significant compensatory sweating (patient-reported or physician-confirmed).'}], 'secondaryOutcomes': [{'measure': 'Operative Time', 'timeFrame': 'Intraoperative (Day 0).', 'description': 'Duration of surgery measured from skin incision to final skin closure, recorded in minutes.'}, {'measure': 'Intraoperative Blood Loss', 'timeFrame': 'Intraoperative (Day 0).', 'description': 'Volume of blood lost during surgery, measured using suction canister collection and gauze weight difference.'}, {'measure': 'Resting Heart Rate', 'timeFrame': 'Baseline (pre-op), 1/3/6/12 months post-op.', 'description': 'Measurement of resting heart rate (beats per minute) at baseline and postoperatively to assess autonomic function changes. Unit of Measure: Beats per minute (bpm).'}, {'measure': 'Resting Blood Pressure', 'timeFrame': 'Baseline (pre-op), 1/3/6/12 months post-op.', 'description': 'Measurement of systolic and diastolic blood pressure (mmHg) at rest to evaluate hemodynamic changes. Unit of Measure: Millimeters of mercury (mmHg).'}, {'measure': 'Plasma Catecholamine Levels', 'timeFrame': 'Baseline (pre-op), 1/3/6/12 months post-op.', 'description': 'Quantification of dopamine, epinephrine, and norepinephrine levels in plasma.'}, {'measure': 'Blood Flow Velocity', 'timeFrame': 'Baseline (pre-op), 1/3/6/12 months post-op.', 'description': 'Doppler ultrasound-derived flow velocity (cm/s) in hands/forehead:\n\nVm (Mean Velocity) = \\[Peak Systolic (Vs) + 2×End-Diastolic (Vd)\\] / 3.'}, {'measure': 'Serum Electrolyte Levels', 'timeFrame': 'Baseline (pre-op), 1/3/6/12 months post-op.', 'description': 'Measurement of sodium (Na⁺), potassium (K⁺), and chloride (Cl-) levels in serum to monitor electrolyte balance.'}, {'measure': 'Liver Function Tests', 'timeFrame': 'Baseline (pre-op), 1/3/6/12 months post-op.', 'description': 'Measurement of liver enzymes (ALT, AST) to assess potential organ toxicity.'}, {'measure': 'Kidney Function Tests', 'timeFrame': 'Baseline (pre-op), 1/3/6/12 months post-op.', 'description': 'Measurement of kidney function markers (creatinine, BUN) to assess potential organ toxicity.'}, {'measure': 'White Blood Cell (WBC) Count', 'timeFrame': 'Baseline (pre-op), 1/3/6/12 months post-op.', 'description': 'Measurement of white blood cell count to monitor for infection, inflammation.'}, {'measure': 'Red Blood Cell (RBC) Count', 'timeFrame': 'Baseline (pre-op), 1/3/6/12 months post-op.', 'description': 'Measurement of red blood cell count to assess anemia risk.'}, {'measure': 'Platelet Count', 'timeFrame': 'Baseline (pre-op), 1/3/6/12 months post-op.', 'description': 'Measurement of platelet count to evaluate clotting potential and risk of thrombocytopenia.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thoracoscopic Sympathectomy (ETS)']}, 'descriptionModule': {'briefSummary': "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.\n\nApproximately 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).\n\nStatistical 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Target Cohort : Adults (18-55 years) diagnosed with primary autonomic dysfunction disorders eligible for thoracoscopic sympathectomy (ETS):\n\nPalmar Hyperhidrosis (PH) : Excessive sweating of the hands. Craniofacial Hyperhidrosis (CH) : Excessive sweating of the head/face. Facial Blushing (FF) : Uncontrolled facial erythema.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis : Confirmed autonomic nervous dysfunction (including palmar hyperhidrosis, craniofacial hyperhidrosis, or facial blushing).\n2. Age : ≥18 years and ≤55 years.\n3. Cardiopulmonary Function :\n\n Normal preoperative chest CT scan and electrocardiogram (ECG).\n4. Performance Status : ECOG score (see Attachment 1) of 0-1, indicating good clinical fitness and ability to perform daily activities independently.\n5. 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.\n\nExclusion Criteria:\n\n1\\. Abnormal Preoperative ECG :\n\n1. Severe arrhythmias:\n\n 1. Type II second-degree or higher atrioventricular block.\n 2. Symptomatic ventricular arrhythmias.\n 3. Uncontrolled supraventricular arrhythmias (resting heart rate \\>100 bpm). These may cause inadequate cardiac output, hypoperfusion of vital organs, and increased surgical risk.\n2. Myocardial ischemia or infarction:\n\n 1. ECG showing ST-segment elevation/depression, T-wave inversion.\n 2. Pathological Q-waves indicating myocardial infarction. 2. Abnormal Chest CT :\n\n1\\) 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.\n\n2\\) Pneumothorax or tension pneumothorax:\n\n1. Significant lung collapse causing dyspnea.\n2. Tension pneumothorax requiring immediate chest tube drainage. 3) Pleural effusion (moderate/large volume): Causes dyspnea or mediastinal shift; surgery may worsen respiratory function.\n\n 3\\. Hyperthyroidism-induced facial blushing or generalized hyperhidrosis. 4. Anesthesia Contraindications : Allergy to anesthetics or high-risk conditions (severe pulmonary/cardiac dysfunction).\n\n 5\\. Cognitive/Psychiatric Impairment : Inability to provide informed consent or understand study risks.\n\n 6\\. Non-Compliance with Follow-up : Inability to adhere to postoperative visits.\n\n 7\\. Immunodeficiency Disorders : Severe immunodeficiency, AIDS, or organ transplant history.\n\n 8\\. Frailty/Advanced Age : Elderly patients with comorbidities or functional decline unfit for surgery.\n\n 9\\. Severe Organ Dysfunction : Cirrhosis, renal failure, or inability to tolerate surgery/recovery.\n\n 10\\. Active Infections : Under antibiotic treatment for pneumonia, tuberculosis, or bacterial infections.\n\n 11\\. Uncontrolled Diabetes : Poor glycemic control with complications (retinopathy, diabetic foot).\n\n 12\\. Concurrent Clinical Trials : Participation in other interventional studies affecting results.\n\n 13\\. Severe Malnutrition : Significant weight loss or nutritional deficiency increasing anesthesia/surgical risks.\n\n 14\\. Hematologic Disorders : Anemia, thrombocytopenia, or coagulopathies affecting hemostasis/recovery.\n\n 15\\. Severe Chronic Respiratory Failure : Long-term ventilator dependence or tracheostomy."}, 'identificationModule': {'nctId': 'NCT07047859', 'briefTitle': 'Clinical Investigation of Sympathetic Nerve Width Measurement in Thoracoscopic Sympathectomy', 'organization': {'class': 'OTHER', 'fullName': 'Tongji University'}, 'officialTitle': 'Clinical Investigation of Sympathetic Nerve Width Measurement in Thoracoscopic Sympathectomy', 'orgStudyIdInfo': {'id': '20250228033833606'}}, 'contactsLocationsModule': {'locations': [{'zip': 'Hongkou Distri 200080', 'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai General Hospital Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Qiongliang Liu, Doctor', 'role': 'CONTACT', 'email': 'qiongliang.liu@shgh.cn', 'phone': '+8618117496385'}], 'overallOfficials': [{'name': 'Xiao Zhou, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai General Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, Hongkou Distri 200080'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jiang Fan', 'investigatorAffiliation': 'Tongji University'}}}}