Lymph Node Yield After Specimen Fixation With Carnoy's Solution and 10% Neutral Buffered Formaldehyde in Patients With Colorectal Cancer or Gastric Adenocarcinoma Specimens: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 主要终点
- Lymph node yield
研究概览
简要总结
This study evaluates the number of lymph nodes dissected in specimens following fixation with 10% neutral buffered formaldehyde or Carnoy's solution. Specimens were randomized for fixation in each solution.
详细描述
Carnoy's solution is a tissue fixative that has alcohol allowing for fat clearing along with tissue fixation. Specimens were randomized after the surgical procedure. The perivisceral fat was removed from the stomach and the lymph node stations disected and then fixed in formalin or carnoy's solution for 24-48h. After dissection the residual fat from the formalin group was re-fixed in carnoy and re-disected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
盲法说明
Randomization occurred after surgery, the surgeon was blind during the procedure
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rectal Cancer:
- •Long course neoadjuvant chemoradiation
- •Low anterior resection with total mesorectal excision
- •Inclusion Criteria - Colon Cancer:
- •Rectosigmoidectomy
- •Inclusion Criteria - Gastric Cancer:
- •Gastric adenocarcinoma
- •Subtotal gastrectomy
- •D2 lymphadenectomy
排除标准
- •Rectal Cancer:
- •Previous surgery
- •Incomplete neoadjuvant chemoradiation
- •Refuse to sign the informed consent
- •T4b and/or Multivisceral resection
- •Exclusion Criteria - Colon Cancer:
- •Previous surgery
- •Neoadjuvant chemoradiation
- •Refuse to sign the informed consent
- •T4b and/or Multivisceral resection
- •Exclusion Criteria - Gastric Cancer:
- •Distant metastasis
- •Previous upper abdomen radiotherapy
- •Previous surgery over stomach or omentum
- •Refuse to sign the informed consent
结局指标
主要结局
Lymph node yield
时间窗: 10 days - accessed with the pathological report for each specimen
Primary outcome will be the total number of lymph nodes dissected in each specimen
次要结局
- Dissection duration(10 days - accessed with the pathological report for each specimen)