Prospective Randomized Clinical Trial of Carbon Nanoparticles as Lymph Node Tracer in Rectal Cancer After Neoadjuvant Radiochemotherapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 252
- 主要终点
- lymph node yield
研究概览
简要总结
The purpose of this study is to evaluate whether injection of carbon nanoparticle as a lymph node tracer before neoadjuvant radiochemotherapy in rectal cancer can increase lymph node yield after surgery compared which do not inject.
详细描述
This is the randomized controlled, multi-centers，and open-labeled study. The lymph node yield was significantly decreased in rectal cancer after neoadjuvant radiochemotherapy (NAT), hard for pathologists to detect, and is difficult to meet the guideline that minimun of 12 lymph nodes should be retrived after surgery in colorectal cancer. Carbon nanoparticle (CNP) is a specific lymph node tracer, which only dyeing the lymph node, and can keep the lymph node in dyeing state in at least half year. The inverstigator attempted to compare the amount of lymph node yield after surgery in locally advanced rectal caner between injection CNP before NAT and no injection CNP before NAT. In this study, the participants with clinical TNM stage T3+ or N+ will be recruited. The participants will be randomized (1:1 ratio) to a control and intervention arm. The participants in the control arm will not receive injection of any kind lymph node tracers. The participants in the intervention arm will receive injection of CNP before NAT. And the specimen would be evaluated by the pathologist.
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
- None
盲法说明
Open label
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years old;
- •Histologically confirmed adenocarcinoma;
- •The rectal adenocarcinoma 0-12cm from the anal margin;
- •Clinical TNM stage: T3+ or N+;
- •Untreated patients (who have not received treatment including radiotherapy, chemotherapy, and surgery);
- •Good liver and kidney function, without contraindications for radiotherapy, chemotherapy or surgery;
- •Able and willing to give informed consent to participate;
排除标准
- •Malignant tumor history or other malignant tumors;
- •Emergency operations such as intestinal obstruction, perforation and hemorrhage;
- •Pregnant or lactating women;
- •History of severe mental illness;
- •Contraindications for radiotherapy, chemotherapy and surgery;
- •Conditions that the researcher thinks it is not suitable for selection.
研究组 & 干预措施
Injection CNP before NAT
Inject carbon nanoparticle as a lymph node tracer before the patient receive neoadjuvant therapy.
干预措施: Injection CNP before NAT (Procedure)
No injection
Do not inject carbon nanoparticle during the treatment.
结局指标
主要结局
lymph node yield
时间窗: up to 30days after total mesorectal excision
Amount of lymph node yield, dyeing lymph node, positive lymph node and the dyeing positive lymph node
次要结局
- Impact on surgical operations(Time of surgery)
- Quality of surgery(Time of surgery)
- Surgery morbidity(30 days and 12-months)
- Overall survival(5-years)
- Disease free survival(5-years)
- Local recurrence rate(5-years)
研究者
YE Yingjiang
Professor of Surgery, Director of Department of Gastroenterological Surgery
Peking University People's Hospital