Identification of the Optimal Functional Lymphatic Vessel for Lymphaticovenous Anastomosis

December 19, 2023 updated by: Haihua Yang, Taizhou Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Zhejiang, China
        • Chong Liu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Aged 18-80 years; Lymphedema and swelling of the limbs for more than 3 months

Description

Inclusion Criteria:

  • lymphedema Paitent

Exclusion Criteria:

  • myoedema Paitent；lipedema Paitent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of size(0.3-0.6mm)
Time Frame: through study completion, an average of 2.5 year
size of lymphatic vessels
through study completion, an average of 2.5 year
Rate of lymphatic vessels contractility
Time Frame: through study completion, an average of 2.5 year
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
Rate of flow
Time Frame: through study completion, an average of 2.5 year
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
Rate of ICG
Time Frame: through study completion, an average of 2.5 year
When observing lymphatic vessels in fluorescence mode, lymphatic vessel fluorescence is considered as ICG positive
through study completion, an average of 2.5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taizhou Hospital

Investigators

  • Study Director: youmao liu, Employee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

December 10, 2023

First Submitted That Met QC Criteria

December 19, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLV20231208

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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