NCT05120180进行中（未招募）不适用
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
Xiangyun Zong4 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2022年1月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 258
- 试验地点
- 4
- 主要终点
- short-term Incidence of lymphedema
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
short-term Incidence of lymphedema
时间窗: 1-, 6-, and 12-month
short-term Incidence of upper limb lymphedema on affected side after operation
short-term Incidence of dysfunction
时间窗: 1-, 6-, and 12-month
short-term Incidence of upper limb dysfunction on affected side after operation
次要结局
- long-term Incidence of lymphedema(5 yearsye)
- long-term Incidence of dysfunction(5 years)
研究者
Xiangyun Zong
Head of Breast Cancer, Principal Investigator, Clinical Professor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Effect of the Axillary Lymphatic /Vein Reflux Ratio on Postoperative Upper Limb Edema and Dysfunction in Breast CancerBreast Cancer LymphedemaNCT05246592Xiangyun Zong258
进行中（未招募）
不适用
The OPBC-07/microNAC StudyBreast CancerNCT06529302University Hospital, Basel, Switzerland2,000
终止
3 期
Surgical Breast Resection With or Without Axillary Lymph Node Excision in Treating Women With Breast CancerBreast CancerNCT00210236Institut Bergonié625
已完成
不适用
Experimental Study About Physiotherapy Treatment vs Self-treatment In Axillary Web Syndrome After Axillary DissectionBreast NeoplasmsNCT04990960Ospedale "Carlo Poma" - Mantova19
招募中
不适用
ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast CancerChemotherapySentinel Lymph NodeAxillary Lymph Nodes DissectionRadiotherapy Side EffectBreast CancerNCT04889924Hospital Universitari de Bellvitge820