Effect of ALND With Vein Branches Reservation on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer (PLEDGE-Surgery)

Xiangyun Zong

Status: Active, not recruiting

Conditions: Breast Cancer Lymphedema

Treatments: Procedure: axillary lymph node dissection without vein branches reservation; Procedure: axillary lymph node dissection with vein branches reservation

Study type: Interventional

Funder types: Other

Identifiers

NCT05120180

JTU-6H-20211011001

Details and patient eligibility

About

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.

Enrollment: 258 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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258 participants in 2 patient groups

Branches Sparing

Experimental group

Description:

The patients in this arm will undergo axillary lymph node dissection with preserved axillary vein branches

Treatment:

Procedure: axillary lymph node dissection with vein branches reservation

None Branches Sparing

Active Comparator group

Description:

The patients in this arm will undergo axillary lymph node dissection without preserved axillary vein branches

Treatment:

Procedure: axillary lymph node dissection without vein branches reservation