Comparison Between the European and Japanese Pathological Investigation for Colon Cancer (SPACE)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 430
- 试验地点
- 2
- 主要终点
- Comparision of the incidence of stage III colon cancer between European and Japanese pathological investigation methods.
研究概览
简要总结
In general, the European pathological examination method primarily relies on pathologists and does not require the involvement of surgeons. The Japanese pathological evaluation approach, on the other hand, involves the intervention of surgeons, particularly in the extraction of lymph nodes from fresh specimens and the assessment of specimen quality. Given that the Japanese pathological assessment method lacks systematic evaluation and there is currently no literature clearly demonstrating its diagnostic accuracy, the main objective of this study is to verify whether the diagnostic accuracy of the Japanese pathological investigation method is inferior to that of the European pathological evaluation method.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with colon cancer who underwent colectomy;
- •Patients with pathological confirmed adenocarcinoma;
- •Patients agreed to participate in the study.
排除标准
- •Patients suffered from rectal cancer;
- •Patients diagnosed with colon cancer but did not undergo colectomy;
- •Patients refused participation.
研究组 & 干预措施
Japanese pathological investigation method group
The surgeon will be involved into the Japanese pathological investigation method. The surgeon will perform the intraoperative markings and the postoperative lymph node harvest, after which the specimen will be assessed by the pathologist.
干预措施: Japanese pathological investigation (Procedure)
European pathological investigation method group
After receiving the resected specimen, the entire process will be independently managed by the pathologist.
干预措施: European pathological investigation (Procedure)
结局指标
主要结局
Comparision of the incidence of stage III colon cancer between European and Japanese pathological investigation methods.
时间窗: up to 24 months
indentification of the rate of postive lymph nodes
次要结局
- The role of immunohistochemical examination in the Node (N) stage determination(up to 24 months)
- Comparison of the resection margin (proximal, distal, circular) between the European and Japanese pathological approaches(up to 24 months)
- Comparison of the lymph node ratio (LNR) between the European and Japanese pathological approaches(up to 24 months)
- Comparison of the tumor budding between the European and Japanese pathological approaches(up to 24 months)
- Comparison of the tumor-infiltrating lymphocytes (TIL) count between the European and Japanese pathological approaches(up to 24 months)
- Comparison of the pT Stage between the European and Japanese pathological approaches(up to 24 months)
- Comparison of the extracapsular invasion between the European and Japanese pathological approaches(up to 24 months)
- Comparison of the extramural invasion (venous, lymphatic, perineural) between the European and Japanese pathological approaches(up to 24 months)
研究者
Vladimir Balaban
Principal Investigator
Russian Society of Colorectal Surgeons