EFFECT OF ENDOSCOPIC TATTOOING WITH CARBON BLACK SUSPENSION ON THE STAGING OF COLON CANCER
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of tumors visualised from peritoneal cavity/number of tattoos visualised form peritoneal cavity
研究概览
简要总结
The study is designed to elucidate whether carbon black suspension endoscopic tattoo enhances visibility of lymph nodes or tumor tissue on dissection of colonic surgical specimen, thereby making improvement in staging defined as better pTNM stage via better visualisation of carbon marked metastatic or sentinel lymph nodes or marked primary tumor or adjacent tissues.
详细描述
Other objectives are:
- to assess intraoperative visibility of carbon black tattoo in the tumor region and surrounding tissues
- to assess microscopic distribution of carbon ink in the layers of the colonic wall and adjacent tissues
- to assess complications related to carbon black tattoo procedure like microscopic fibrosis, micro- or macroscopic scarring, inflammatory reactions
- to assess long-term effects of ink injections on control endoscopies at 6 and 12 months
- to assess dissection time in tattooed-non tattooed lymphatic tissues
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
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 years or above undergoing colonoscopy for suspected colonic malignancy
- •Participant is able to give informed consent for participation in the study
- •Patient is presumably selected for surgery within 30 days following tattoo injection
排除标准
- •Patients under the age of 18
- •Patients unable to give informed consent or ineligible for surgery
- •Tumor in the coecum dome or in the rectum (<15 cm)
- •Known allergy to suspension ingredients
结局指标
主要结局
Number of tumors visualised from peritoneal cavity/number of tattoos visualised form peritoneal cavity
时间窗: 1 year
Distance in cm from tumor wich far carbon injection marked mucosa and adjacent tissues Number of inflammatory cells per field of view in injection site vs. non-injected mucosa Number of dissected total/normal/metastatic/carbon colored lymph nodes
次要结局
未报告次要终点
研究者
Matyas Czepan
Head of Division of Internal Medicine 2/S
Szeged University