Identification of the Optimal Functional Lymphatic Vessel for Lymphaticovenous Anastomosis

Lymphedema Clinical Trial

Official title:

Intraoperative Identification of the Optimal Functional Lymphatic Vessel for Lymphaticovenous Anastomosis in Upper Limb Extremity Lymphedema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06191081
• Other study ID #: FLV20231208
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: December 2023
• Source: Taizhou Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to further explore the optimal screening factors for functional lymphatic vessels in lymphaticovenous anastomosis in patients with lymphedema.

Description:

By analyzing the size of lymphatic vessels (0.3-0.6mm), ICG imaging, contraction characteristics of lymphatic vessels and lymphatic flow in patients with lymphedema, the effect of functional lymphatic vessel selection on lymphatic drainage in patients with lymphedema was judged during operation, so as to provide a more scientific basis for the selection of functional lymphatic vessels in clinical surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: October 1, 2023
• Est. primary completion date: June 1, 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• lymphedema Paitent

Exclusion Criteria:

• myoedema Paitent;lipedema Paitent

Related Conditions & MeSH terms

• Lymphedema

Intervention

Procedure:
• lymphaticovenous anastomosis
lymphaticovenous anastomosis

Locations

Country	Name	City	State
China	Chong Liu	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Taizhou Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of size(0.3-0.6mm)	size of lymphatic vessels	through study completion, an average of 2.5 year
Primary	Rate of lymphatic vessels contractility	When observing lymphatic vessels in fluorescence mode, a contraction occurring within 10 seconds is considered as contractility positive	through study completion, an average of 2.5 year
Primary	Rate of flow	while the presence of lymphatic fluid flowing out after cutting the lymphatic vessel is considered as flow positive	through study completion, an average of 2.5 year
Primary	Rate of ICG	When observing lymphatic vessels in fluorescence mode, lymphatic vessel fluorescence is considered as ICG positive	through study completion, an average of 2.5 year