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临床试验/NCT02885142
NCT02885142终止不适用

Early Rectal Cancer: Endoscopic Submucosal Dissection or Transanal Endoscopic Microsurgery?

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 368 人开始时间: 2016年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
368
试验地点
2
主要终点
Number of complete excision for TEM compare to number of complete excision for ESD in rectal carcinomas staged usT1N0 and rectal adenomas.

研究概览

简要总结

Local excision for early rectal cancer has proven its feasibility and oncological safety. Indeed, lymph node invasion does not exceed 1% and 10% in pT1sm1 and pT1sm2 rectal carcinomas respectively. Two procedures are currently performed in these early cancers as well as in preneoplastic lesions. Transanal endoscopic microsurgery (TEM), which has proven its superiority over traditional transanal excision, is a surgical approach associated with a 92% R0 excision rate, a survival comparable to radical anterior resection and a low morbidity. It consists of a full-thickness excision. The second procedure is a recently introduced technique: the endoscopic submucosal dissection (ESD), which encompasses only the mucosa and submucosa. ESD enables endoscopists to achieve higher en bloc resection rates than standard mucosectomy and is associated with a 88% R0 resection rate, which decreases to 65% in the subgroup of European series. Though very promising, the role of ESD remains controversial in malignant lesions with few published reports. There are therefore 2 different techniques with 2 different dissections (full-thickness vs. submucosal) to achieve the same oncological treatment. So far, only one retrospective single-center study including 63 patients has compared TEM and ESD in early rectal cancer without finding any difference between the 2 procedures, and there are no other available studies comparing TEM and ESD for any type of colorectal tumor. The aim of the present research is to compare ESD with TEM for early rectal cancer and rectal adenomas for short- and long-term outcomes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Presenting with an ERT (i.e. rectal adenoma or rectal carcinoma Tis or staged usT1N0 on endorectal ultrasound) that can be alternately resectable by TEM or ESD
  • Histology proved by a preoperative biopsy

排除标准

  • " Palliative " excision T2/3/4 or N+
  • Preoperative radiochemotherapy (down-staging)
  • Metastatic cancer
  • Pregnant or breast-feeding women

结局指标

主要结局

Number of complete excision for TEM compare to number of complete excision for ESD in rectal carcinomas staged usT1N0 and rectal adenomas.

时间窗: 3 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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