Effect of ALND With Vein Branches Reservation on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer

Postoperative Upper Limb Edema and Dysfunction Generated by Axillary Nodes Excision With or Without Axillary Vein Branches Reservation in Breast Cancer Patients: a Prospective, Multiple-center, Double-blinded, Randomized Controlled Study

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05120180

Acronym

PLEDGE-Surgery

Enrollment

258

Registered

2021-11-15

Start date

2022-01-03

Completion date

2029-04-01

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Lymphedema

Keywords

Breast Cancer, Axillary Lymph Node Dissection, Post-mastectomy Lymphedema, Upper Limb Dysfunction, Axillary Vein Branches Reservation

Brief summary

The purpose of this study is to compare the effects of axillary lymph node dissection with or without axillary vein branches reservation on the affected upper limb edema and dysfunction in breast cancer patients, and to explore the solutions to prevent the affected upper limb edema and dysfunction after ALND.

Interventions

PROCEDUREaxillary lymph node dissection with vein branches reservation

Spare the vein branches when ALND being performed

PROCEDUREaxillary lymph node dissection without vein branches reservation

Don't spare the vein branches when ALND being performed

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

Healthy volunteers

Inclusion criteria

* Age 18-69 years old, * Regardless of gender, * Breast masses were diagnosed by histology and pathology, stage II -III. * Clinical palpation of axillary lymph nodes is positive, or * Axillary lymph node puncture pathology is positive, or * The multidisciplinary treatment cooperation group (MDT) recommends axillary lymph node dissection, * Good physical state score (0-2), * No severe organ complications, * No congenital or acquired diseases affecting the normal morphology and functional activities of the upper limbs, * Informed consent, understanding and compliance with research requirements.

Exclusion criteria

* Pregnancy or lactation, * Inflammatory breast cancer, * Clinical findings of metastatic lesions, * Sentinel lymph node biopsy was negative, * History of upper limb or shoulder, chest, back trauma or surgery, * Previous history of local radiotherapy, * History of other tumors, * Vascular embolic disease, * Those who are unable to comply with the clinical trial requirements for any reason.

Design outcomes

Primary

Measure	Time frame	Description
short-term Incidence of lymphedema	1-, 6-, and 12-month	short-term Incidence of upper limb lymphedema on affected side after operation
short-term Incidence of dysfunction	1-, 6-, and 12-month	short-term Incidence of upper limb dysfunction on affected side after operation

Secondary

Measure	Time frame	Description
long-term Incidence of lymphedema	5 yearsye	long-term Incidence of upper limb lymphedema on affected side after operation
long-term Incidence of dysfunction	5 years	long-term Incidence of upper limb dysfunction on affected side after operation

Other

Measure	Time frame	Description
TFS	5 years	tumor-free survival

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026