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临床试验/NCT00531297
NCT00531297终止不适用

Endoscopic Posterior Mesorectal Resection in T1 Rectal Cancer

Cantonal Hospital of St. Gallen2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2005年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
18
试验地点
2
主要终点
Recurrence rate

研究概览

简要总结

Any efforts to spare patients with T1 carcinomas of the rectum from low anterior resection or even abdominoperineal resection are linked to the risk of locoregional recurrence of about 10% (range, 0-24). This is tolerated in the view of the morbidity and mortality risk related to transabdominal resection, which is as high as 7-68% and 0-6.5%, respectively. Accordingly, in addition to transanal local excision various adjuvant therapy schemes with chemo- and/or radiotherapy were developed, given the uncertainty about the lymph node stage. Another approach was to identify histological risk criteria in the primary tumor in terms of defining the limits of rectum-sparing therapy.

In earlier experimental and clinical studies the investigators researched and applied dorsoposterior extraperitoneal pelviscopy, i.e. perineal access to the soft-tissue areas of the minor pelvis using minimally invasive surgery. in T1 carcinoma of the rectum this technique becomes all the more significant, as the perineal approach makes it possible to perform an endoscopic posterior mesorectal resection (EPMR) in combination with rectum-sparing surgery Thereby the relevant lymphatic field of the lower rectum can be removed and histologically examined. As a consequence EPMR should lower the loco-regional recurrence rate, since the most common causes of such are pre-existent but so far not detectable lymph node metastases besides the incomplete resection of the primary tumor.

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

入选标准

  • Stage T1 (only)
  • Over 18 years old
  • Patient's consent
  • Previous R0 resection of rectal tumor

排除标准

  • Metastases (M1)
  • Neoadjuvant chemotherapy or radiotherapy
  • Meta- or synchronous tumors

研究组 & 干预措施

Treatment arm

Experimental

endoscopic posterior mesorectal resection

干预措施: endoscopic posterior mesorectal resection (Procedure)

结局指标

主要结局

Recurrence rate

时间窗: 5 years

次要结局

  • Morbidity (>= CTCAE grade 3)(30 days)
  • Perioperative mortality(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ignazio Tarantino

M.D.

Cantonal Hospital of St. Gallen

研究点 (2)

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