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Search / Trial NCT07047859

Clinical Investigation of Sympathetic Nerve Width Measurement in Thoracoscopic Sympathectomy

Launched by TONGJI UNIVERSITY · Jun 30, 2025

Trial Information

Current as of July 27, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new way to improve a surgery called thoracoscopic sympathectomy (ETS), which is used to treat conditions like excessive sweating of the palms and face, as well as facial blushing. The researchers want to see if measuring the width of a certain nerve during the surgery can help predict how well patients will do afterward. They will use a special tool that measures the nerve very precisely and then check if this measurement relates to the surgery’s success, side effects like sweating in other areas, and how satisfied patients feel up to a year later.

The study plans to include about 1,000 adults between 18 and 55 years old who have been diagnosed with these conditions and are generally healthy enough for surgery. Before joining, patients will need to have normal heart and lung tests and be able to understand and agree to the study details. During the surgery, doctors will collect several types of information, including temperature changes and heart measurements, and patients will be asked to fill out surveys about their symptoms and satisfaction. This study aims to make the surgery safer and more effective, ultimately improving quality of life for people with these conditions.

Gender

ALL

Eligibility criteria

  • 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.

About Tongji University

Tongji University, a prestigious institution located in Shanghai, China, is renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, Tongji University leverages its extensive resources and expertise in various fields of healthcare to facilitate innovative clinical studies aimed at improving patient outcomes. The university collaborates with leading researchers and healthcare professionals to conduct rigorous trials that adhere to international standards of scientific integrity and ethical practice. Through its dedication to translational medicine and interdisciplinary collaboration, Tongji University plays a pivotal role in fostering advancements in medical science and addressing pressing health challenges.

Locations

Shanghai, , China

Patients applied

0 patients applied

Trial Officials

Xiao Zhou, Doctor

Principal Investigator

Shanghai General Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, Hongkou Distri 200080

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported