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

Not Applicable

Recruiting

• Conditions: Breast Cancer Lymphedema
• Interventions: Procedure: axillary lymph node dissection with vein branches reservation; Procedure: axillary lymph node dissection without vein branches reservation

• Registration Number: NCT05120180
• Lead Sponsor: Xiangyun Zong

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-11-02
• Study First Posted: 2021-11-15
• Study Start: 2022-01-03
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-24
• Primary Completion: 2024-01-31
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 261

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Branches Sparing	axillary lymph node dissection with vein branches reservation	The patients in this arm will undergo axillary lymph node dissection with preserved axillary vein branches
None Branches Sparing	axillary lymph node dissection without vein branches reservation	The patients in this arm will undergo axillary lymph node dissection without preserved axillary vein branches

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Shanghai Fengxian Central Hospital; 🇨🇳 Shanghai, China

Shanghai Jiao Tong University Affiliated Sixth People's Hospital; 🇨🇳 Shanghai, Shanghai, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China