Phase II Clinical Trial for the Evaluation of the Efficacy of Transanal Total Mesorectal Excision
试验速览
- 阶段
- 不适用
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- TME quality & circumferential resection margin (CRM)
研究概览
简要总结
The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision.
详细描述
Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age: 20-80 years
- •biopsy-proven adenocarcinoma of the rectum
- •clinical staging (c or yc): T0-3, N0-2, M0
- •Rectal cancer located 3-12 cm from the anal verge
- •ECOG performance status: 2 or less
- •BMI: less than 30
排除标准
- •Synchronous colon cancer or other malignancy
- •Obstructing rectal cancer
- •Pregnant or breast-feeding
- •Receiving any other study agents
- •Fecal incontinence
- •History of prior colorectal cancer or inflammatory bowel disease
- •Tumor size: more than 7cm in long diameter
- •CRM: mesorectal fascia involvement or less than 1 mm on MRI
结局指标
主要结局
TME quality & circumferential resection margin (CRM)
时间窗: the day of trananal TME
The quality of the mesorectum was determined using pathology reports and scored using three grades: * Complete: intact mesorectum with only minor irregularities of a smooth mesorectal surface. No defect is deeper than 5 mm, and there is no coning toward the distal margin of the specimen. There is a smooth circumferential resection margin on slicing. * Nearly complete: moderate bulk to the mesorectum, but irregularity of the mesorectal surface. Moderate coning of the specimen is allowed. At no site is the muscularis propria visible, with the exception of the insertion of the levator muscles. * Incomplete: little bulk to mesorectum with defects down onto muscularis propria and/or very irregular circumferential resection margin.
次要结局
- 30-day postoperative complications(1 month after surgery)
- Number of harvested Lymph Nodes(the day of surgery)
研究者
Dae Kyung Sohn
MD., PHD, Center for Colorectal Cancer
National Cancer Center, Korea