Can ILR Reduce the Risk of Arm Lymphedema? | NCT05742945

Studies
Can ILR Reduce the Risk of Arm Lymphedema?

NCT05742945

Sponsor

National Taiwan University Hospital

Status

Active, not recruiting

Last Update Posted

Mar 19, 2024Actual

Enrollment

240Estimated

Phase

Not Applicable

Conditions

Breast Cancer Lymphedema

Interventions

Immediate lymphatic reconstruction

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

Mar 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 14, 2023Actual

Primary Completion Date

Aug 2028Estimated

Completion Date

Aug 2028Estimated

First Submitted Date

Feb 15, 2023

First Submission Date that Met QC Criteria

Feb 15, 2023

First Posted Date

Feb 24, 2023Actual

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

Mar 17, 2024

Last Update Posted Date

Mar 19, 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

Breast cancer-related lymphedema (BCRL) is a debilitating, usually lifelong burden for breast cancer survivors. For the breast cancer patients receiving axillary lymph node dissection (ALND), the likelihood of BCRL is about 20%. Lymphatico-venous anastomosis (LVA) has been accepted as a method of treating extremity lymphedema. A few studies have mentioned the prophylactic effect of LVA on BCRL. However, there is still lack of a large-scale randomized controlled trial to corroborate its efficacy. Therefore, the goal of this study is to conduct a prospective randomized controlled trial to evaluate if immediate lymphatic reconstruction (ILR) with LVA could have a clinically significant effect on the reduction of BCRL occurrence.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ILR	Experimental	Breast cancer patients receiving axillary lymph node dissection and immediate lymphatic reconstruction	Procedure: Immediate lymphatic reconstruction
non-ILR	No Intervention	Breast cancer patients receiving only axillary lymph node dissection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Immediate lymphatic reconstruction	Procedure	Breast cancer patients receive axillary lymph node dissection and immediate lymphatic reconstruction	ILR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Arm lymphedema	Occurrence of arm lymphedema	Two years

Secondary Outcomes

Measure	Description	Time Frame
Drainage amount	Drainage amount from operative wounds	Two weeks
Seroma or lymphocele	Occurrence of seroma or lymphocele	One month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female patients with unilateral breast cancer
Going to receive axillary lymph node dissection, or sentinel lymph node biopsy but being highly suspected of axillary metastasis preoperatively

Exclusion Criteria:

Had received axillary lymph node dissection
Going to receive bilateral axillary lymph node dissections
Already have arm lymphedema
Allergy to the dye used intraoperatively

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hao-Chih Dai, MD, PhD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei			Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Non-identifiable data will be shared upon request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000072656	Breast Cancer Lymphedema

Ancestor Terms

ID	Term
D008209	Lymphedema
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided