Impact of a Surgical Sealing Patch on Lymphatic Drainage After Axillary Lymph Node Dissection for Breast Cancer. A Multicenter Randomized Phase III Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 16
- 主要终点
- Total volume of axillary drainage
研究概览
简要总结
Axillary lymph node dissection remains an integral part of surgical treatment of primarily node-positive invasive breast cancer. In order to reduce the incidence of clinically relevant seroma, a suction drain is routinely placed into the axillary cavity after axillary lymph node dissection (ALND) by a separate stab incision. The pathogenesis of seroma involves the collection of lymph fluid caused by dissection of lymph vessels and exudate. All coagulation and fibrinolytic factors are produced and secreted by lymphatic endothelial cells and are involved in the sealing of lymphatic capillaries. Local hemostyptic agents may therefore reduce postoperative secretion from lymphatic fistulas caused by ALND.
We propose to conduct a multicenter prospective randomized control trial in Switzerland to evaluate the impact of TachoSil®, a ready-to-use, absorbable surgical patch (consisting of an equine collagen sponge coated with human fibrinogen and human thrombin) on axillary drainage after ALND for breast cancer. We hypothesize that the use of TachoSil® significantly and relevantly reduces the volume and duration of axillary drainage after ALND. This has the potential to increase patients' quality of life, as well as to shorten the length of hospital stay and reduce hospital costs.
详细描述
DISEASE BACKGROUND
In Switzerland, 5'500 women and 30 to 40 men are diagnosed with breast cancer every year. It accounts for one third of all cancer diagnoses among women, and causes approximately 1'350 deaths per year. Around 1'200 patients per year need axillary lymph node dissection (ALND) as part of their surgical treatment. ALND is indicated primarily for node-positive breast cancer. Patients are identified either by pre-operative evaluation of the axilla or by intraoperative sentinel lymph node biopsy (SLNB).
THERAPY BACKGROUND
During axillary lymph node dissection for breast cancer, standard techniques for prevention of leakage of dissected lymphatic vessels include the application of suture ligaments and the use of bipolar electrocautery. Seroma prevention after ALND is achieved by placement of a closed suction drain through the skin into the axillary cavity.
Closed axillary suction drains are archaic tools to prevent seroma after ALND by simple mechanical drainage at the cost of significant patient discomfort and increased length of hospital stay. The sealing agent TachoSil® (consists of an equine collagen sponge coated with human fibrinogen and human thrombin) allows a more nuanced approach to the management of axillary seroma prevention and may support ongoing and decades-old efforts of the professional breast cancer community to decrease the duration of axillary drainage and finally, to abandon the drain from routine clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •at registration
- •Patient has given written informed consent before registration
- •Female patients; eligible for primary ALND or sentinel lymph node procedure with frozen section and either:
- •newly diagnosed
- •or recurrent breast cancer in the conserved breast, chest wall or axilla
- •Patients with histo- or cytology proven breast cancer UICC/AJCC stage I-III
- •Age ≥ 18 years
- •Fluency in either German, French, Italian, Spanish, Turkish or English
- •The EQ-5D questionnaire has been completed at registration
- •Patient with child-bearing potential, willing to use effective contraception, not currently pregnant and agreeing not to become pregnant after trial registration and during the 24 weeks after surgery
- •A negative pregnancy test within 14 days prior to inclusion is available for all women with child-bearing potential
- •Inclusion criteria at randomization
- •ALND indicated according to clinical standards, either as single procedure or in combination with breast conserving surgery
- •Exclusion Criteria at registration:
- •Known hypersensitivity for TachoSil® or fibrin sealant
- •Patients with mastectomy (simultaneously or within 1 month before registration); patients undergoing completion mastectomy at a later day will remain eligible and are evaluable for analysis according to intention to treat. If the axillary drain is still in place at the time of completion mastectomy and a separate drain is inserted underneath the skin flaps, only the axillary drain will be considered
- •Prior axillary dissection (except prior sentinel node procedure)
- •Prior axillary radiotherapy
- •Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, filling out QoL forms
- •Concurrent treatment with other experimental drugs or treatment in a clinical trial within 30 days prior to trial entry
排除标准
- 未提供
研究组 & 干预措施
Arm B: TachoSil®
After axillary lymph node dissection, 3 large TachoSil® patches in the dissected axilla are positioned to cover as much of the axillary walls as possible.
干预措施: TachoSil® patches (Drug)
结局指标
主要结局
Total volume of axillary drainage
时间窗: until drain removal (2 - 10 days after surgery)
Total volume of axillary drainage in ml until drain removal.
次要结局
- Volume of axillary drainage per 24 hours(until drain removal (2 - 10 days after surgery))
- Number of clinically relevant seroma aspirations(until 24 weeks after surgery)
- Patients with clinically relevant seroma(until 24 weeks after surgery)
- Total duration of axillary drainage in days(until drain removal (2 - 10 days after surgery))
- Duration of postoperative hospital stay in days(between 3-6 days after surgery)
- Total volume of all clinically relevant seroma aspirations in ml(until 24 weeks after surgery)