Endoscopic Submucosal Dissection Versus Local Laparoscopic Surgical Resection (Transanal Minimally Invasive Surgery [TAMIS] / Transanal Endoscopic Operation [TEO]) In Early Rectal Neoplasias. Multicentric and Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- local recurrence rate
研究概览
简要总结
A multicenter non-inferiority randomized clinical trial to compare Endoscopic treatment (ESD) and Minimally Invasive Laparoscopic Local Surgical Treatment (TAMIS or TEO) for early rectal neoplastic lesions (adenoma & T1CRC) Primary aim: To compare the long-term local recurrence rate (12 months after the procedure)
Secondary aims:
Compare en-bloq resection rate, R0 resection, time per procedure, short-term recurrence rate, safety (rate of complications), morbidity and cost-effectiveness analyses.
详细描述
A multicenter non-inferiority randomized clinical trial is proposed to compare two types of treatment for early rectal neoplastic lesions. Study arms:
- Endoscopic treatment: Endoscopic Submucosal Dissection (ESD)
- Minimally invasive laparoscopic local surgical treatment: Transanal Minimally Invasive Surgery (TAMIS) or Transanal Endoscopic Operation (TEO).
Aims:
Primary aim: To compare the long-term local recurrence rate (12 months after the procedure) of rectal lesions after ESD vs Surgical treatment (TAMIS/TEO).
Secondary aims: Both arms of the study are compared according to other efficacy-related variables (en-bloq resection rate, R0 resection, time per procedure, short-term recurrence rate [6 months]), safety (rate of complications), morbidity (comparing different specific indexes: Wexner index, EQ-5L-5D, etc) and cost-effectiveness analyses (QALY).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Patients older than 18 y/o
- •Non-pedunculated rectal lesions (sessile 0-Is or flat 0-II) greater than 20 mm in diameter.
- •The edges of the lesion should be more than 3 cm from the external anal margin and up to 14 cm from it.
- •Circumferential involvement <50%
排除标准
- •Patients who refuse to participate.
- •Diagnosis of inflammatory bowel disease with rectal involvement.
- •Pregnant.
- •Anorectal fibrosis due to previous anorectal surgery.
- •Lateral Spreading Lesions (LST classification) Granular Homogeneous type
- •Lesions greater than 50 mm when there is suspicion of advanced histology (Kudo Vi superficial pattern).
- •Rectal lesions of any size with high suspicion of deep submucosal invasion or locoregional lymph node involvement, either in the diagnostic colonoscopy (Kudo Vn pit pattern, NICE 3 pattern, Sano IIIB pattern) or by complementary imaging tests (rectal EUS/Pelvic MRI)
- •Existence of synchronous colorectal lesions that require other surgical treatment in any case.
结局指标
主要结局
local recurrence rate
时间窗: 12 months
presence of remaining neoplastic tissue in resection site
次要结局
- Cost-effectiveness analyses (QALY)(12 months)
- R0 resection rate(1 hour)
- Short-term local recurrence rate(6 months)
- Early complications rate(1 hour)
- Time per procedure(1 hour)
- Length of hospital stay(1 hour)
- En-bloq resection rate(1 hour)
- Delayed complications rate(1 hour)
- Morbidity(12 months)
研究者
Dr. Alberto Herreros de Tejada Echanojáuregui
Principal Investigator
Puerta de Hierro University Hospital