Effect of the Axillary Lymphatic /Vein Reflux Ratio on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer

NCT05246592 | Active Not Recruiting DMC

• 1 other identifier: JTU-6H-20211230001
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to compare the difference in the incidence of upper limb edema and dysfunction between the Preponderant lymphatic reflux group (high ratio of axillary lymphatic reflux to axillary vein reflux) and the Preponderant venous reflux group (low ratio of axillary lymphatic reflux to axillary vein reflux).

Conditions

Breast Cancer Lymphedema

Keywords

Breast Cancer; Axillary Lymph Node Dissection; Post-mastectomy Lymphedema; Upper Limb Dysfunction; axillary lymphatic reflux; axillary vein reflux

Outcome Measures

Primary Outcomes (2)

• short-term Incidence of lymphedema

  Incidence of upper limb lymphedema on affected side at 1-, 6-, and 12-month after operation

  1-, 6-, and 12-month

• short-term Incidence of dysfunction

  Incidence of upper limb dysfunction on affected side at 1-, 6-, and 12-month after operation

  1-, 6-, and 12-month

Secondary Outcomes (2)

• long-term Incidence of lymphedema

  5 years

• long-term Incidence of dysfunction

  5 years

Other Outcomes (1)

• Risk model

  5 years

Study Arms (2)

Preponderant lymphatic reflux group

high ratio of axillary lymphatic reflux to axillary vein reflux

Procedure: Branches Sparing; Procedure: None Branches Sparing

Preponderant venous reflux group

low ratio of axillary lymphatic reflux to axillary vein reflux

Procedure: Branches Sparing; Procedure: None Branches Sparing

Interventions

Branches Sparing PROCEDURE

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

Preponderant lymphatic reflux group; Preponderant venous reflux group

None Branches Sparing PROCEDURE

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

Preponderant lymphatic reflux group; Preponderant venous reflux group

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients recruited in the PLEDGE study （NCT05120180）

You may qualify if:

• 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 (0-1),
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangyun Zong: lead

Study Sites (3)

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200233, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Shanghai Fengxian Central Hospital

Shanghai, 201499, China

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema; Breast Neoplasms

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• XIANGYUN ZONG, MD, PhD

  Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Breast Cancer, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 18, 2022
• Study Start: January 1, 2022
• Primary Completion: April 1, 2024
• Study Completion (Estimated): April 1, 2029
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)