NCT03840655

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

10 months

First QC Date

February 9, 2019

Last Update Submit

February 12, 2019

Conditions

Palmar Hyperhidrosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Improvement of palmar sweating

    1 month after surgery

  • Degree of compensatory hyperhidrosis

    1 month after surgery

Study Arms (1)

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

Interventions

Near-Infrared Imaging ThoracoscopyPROCEDURE

Sympathicotomy performed by near-infrared imaging thoracoscopy

palmar hyperhidrosis

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients suffering from primary palmar hyperhidrosis

You may qualify if:

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

You may not qualify if:

  • Liver dysfunction.
  • Allergic to indocyanine green.
  • Can't tolerate thoracoscopic surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People'S Hospital

Beijing, Beijing Municipality, +86-010, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department Chief

Study Record Dates

First Submitted

February 9, 2019

First Posted

February 15, 2019

Study Start

November 16, 2017

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

CN(1)