Fluorescent Thoracoscopy Used in Surgery for Palmar Hyperhidrosis

Palmar Hyperhidrosis Clinical Trial

Official title:

Fluorescent Thoracoscopy Used in Surgery for Palmar Hyperhidrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03840655
• Other study ID #: 2017PHB101-01
• Status: Completed
• Start date: November 16, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: February 2019
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: September 1, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperhidrosis
• Palmar Hyperhidrosis

Intervention

Procedure:
• Near-Infrared Imaging Thoracoscopy
Sympathicotomy performed by near-infrared imaging thoracoscopy

Locations

Country	Name	City	State
China	Peking University People'S Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University People's Hospital	Beijing Municipal Science & Technology Commission

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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