Fluorescent Thoracoscopy Used in Surgery for Palmar Hyperhidrosis

T3/T4 endoscopic thoracic sympathicotomy is a widely accepted and effective treatment for primary palmar hyperhidrosis. However, sympathetic ganglions are invisible with traditional thoracoscopy and until now, the location of ganglions are confirmed by rib indirectly. The team from thoracic department of Peking University People's Hospital discovered that the sympathetic ganglions can be visualized with fluorescent thoracoscopy. Thus, investigators want to apply fluorescent thoracoscopy in sympathicotomy of palmar hyperhidrosis, to conduct a more precise operation and compare the efficiency of the novel and traditional methods.

Study Overview

• Status: Completed
• Conditions: Palmar Hyperhidrosis
• Intervention / Treatment: Procedure: Near-Infrared Imaging Thoracoscopy

• Study Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, +86-010
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 75 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients suffering from primary palmar hyperhidrosis

Description

Inclusion Criteria:

1. Diagnosed with primary palmar hyperhydrosis.
2. Accept surgical treatment and signed informed consent.

Exclusion Criteria:

1. Liver dysfunction.
2. Allergic to indocyanine green.
3. Can't tolerate thoracoscopic surgery.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
palmar hyperhidrosis; VATS R4 Sympathicotomy performed on all patients. Fluorescent thoracoscopy was used to identify the shifting mode of sympathetic ganglions.	Procedure: Near-Infrared Imaging Thoracoscopy; Sympathicotomy performed by near-infrared imaging thoracoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anatomical variation of the sympathetic ganglions	Record the spatial relationship between sympathetic ganglions and ribs, for example: T3/R4 represents the T3 sympathetic ganglion is located on the 4th rib.	during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of palmar sweating	Use questionnaire including 3 descriptive names of scale ( over dry, comfortable and wet) to record the surgical effect on palmar sweating.	1 month after surgery
Degree of compensatory hyperhidrosis	Use questionnaire including 4 descriptive names of scale ( none, mild, moderate and severe) to record the side effect (compensatory hyperhidrosis) of this surgery.	1 month after surgery

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Beijing Municipal Science & Technology Commission

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2017
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: February 9, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis
• Other Study ID Numbers: 2017PHB101-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No