Lymphatic System Reflux After Lymphatic Operation | NCT06249360

Studies
Lymphatic System Reflux After Lymphatic Operation

NCT06249360

Sponsor

Chang Gung Memorial Hospital

Status

Completed

Last Update Posted

Feb 8, 2024Actual

Enrollment

79Actual

Phase

Not provided

Conditions

Lymphedema

Interventions

Veins with reflux
Reflux-free recipient veins

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2023Actual

Primary Completion Date

Nov 15, 2023Actual

Completion Date

Dec 30, 2023Actual

First Submitted Date

Jan 31, 2024

First Submission Date that Met QC Criteria

Jan 31, 2024

First Posted Date

Feb 8, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2024

Last Update Posted Date

Feb 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aimed to determine the impact on outcomes when recipient veins with reflux were used for LVA for the treatment of unilateral lower limb lymphedema.

Detailed Description

The use of recipient veins with reflux for lymphaticovenous anastomosis (LVA) is discouraged because of the common belief that it may lead to venous-lymphatic reflux (VLR), a phenomenon in which venous blood is refluxed into the lymphatic lumen after anastomosis, which can lower the long-term patency rate. However, this concept has yet to be validated.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

79Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lower Limb Lymphedema		Patients with cancer-related unilateral lower limb lymphedema were enrolled.	Other: Veins with reflux Other: Reflux-free recipient veins

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Veins with reflux	Other	This group included patients who used only recipient veins with reflux	Lower Limb Lymphedema

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Volume change after LVA.	The primary endpoint was the volume change at 6/12 months after LVA.	6/12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

This study including patients diagnosed with lymphatic-related diseases at Kaohsiung Chang Gung Memorial Hospital from October 1, 2015, to December 31, 2022.
Patients who underwent LVA for unilateral lower-limb lymphedema.

Exclusion Criteria:

Patients under the age of 20.
Patients lost to follow-up or with incomplete data.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

All adult patients (age >20 years) receiving LVA for lower limb lymphedema at a tertiary medical center were retrospectively reviewed from October 2015 to December 2022.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaohsiung Chang Gung Memorial Hospital		Kaohsiung City		83301	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D008209	Lymphedema

Ancestor Terms

ID	Term
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

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