Endoscopic Submucosal Dissection (ESD) Versus Transanal Minimally Invasive Surgery (TAMIS) for Early Rectal Neoplasms: a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Short-term morbidity
研究概览
简要总结
This is a prospective randomized controlled trial that aimed to compare the short-term clinical outcomes, functional outcomes, costs, and recurrence rates between endoscopic submucosal dissection (ESD) and transanal minimally invasive surgery (TAMIS) for early rectal neoplasms.
详细描述
Background: Transanal minimally invasive surgery (TAMIS) is an effective surgical alternative to transanal excision for treating early rectal neoplasms not amenable to en bloc resection by conventional colonoscopic techniques. Endoscopic submucosal dissection (ESD) is a revolutionary endoscopic procedure that enables en bloc resection of large rectal neoplasms with low morbidity. To date, no randomized controlled trial can be found in the literature comparing the two modalities.
Objectives: To compare the short-term clinical outcomes, functional outcomes, costs, and recurrence rates between ESD and TAMIS for early rectal neoplasms.
Design: Prospective randomized controlled trial.
Subjects: One hundred and fourteen consecutive patients diagnosed with early rectal neoplasms (>/=2 cm in size and without evidence of deep submucosal invasion) that are not amenable to en bloc resection by conventional colonoscopic techniques will be recruited.
Interventions: Patients will be randomly allocated to receive either ESD or TAMIS.
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 diagnosed with nonpedunculated early rectal neoplasms \>/= 2 cm in size in the rectum (\>/= 3 cm and \18 years;
- •* American Society of Anesthesiologists (ASA) grading I-III
- •* Informed consent available
排除标准
- •Presence of endoscopic signs of massive submucosal invasion (including excavated/depressed morphology, Kudo's pit pattern Type V, or Sano's capillary pattern Type IIIB)
- •Evidence of deep invasion on endorectal ultrasonography
- •Unfavorable histopathologic features on biopsy (mucinous cancer, poor differentiation, or gross submucosal invasion)
- •Patients with other synchronous colorectal neoplasms in addition to the index neoplasm that are indicated for surgical resection
- •Patients with recurrence from previous Endoscopic Mucosal Resection or ESD
- •Patients with known metastatic disease
- •Patients with non-correctable coagulopathy
研究组 & 干预措施
ESD
ESD is an endoscopic procedure that enables en bloc resection of large tumors in the gastrointestinal tract, irrespective of the size of the lesion. ESD uses an electrosurgical cutting device to purposely dissect the deeper layers of the submucosa to remove neoplastic mucosal lesions in a single piece.
干预措施: ESD (Procedure)
TAMIS
TAMIS is a minimally invasive means of removing large rectal neoplastic lesions not accessible by conventional transanal excision. It is performed using the GelPOINT path transanal access platform and laparoscopic instruments.
干预措施: TAMIS (Procedure)
结局指标
主要结局
Short-term morbidity
时间窗: Up to 1 month
Short-term morbidity/mortality within 30 days after the procedure (including intraprocedural morbidity/mortality), defined by the Clavien-Dindo classification of surgical complications
次要结局
- Time to walk independently(Up to 1 month)
- Length of hospital stay(Up to 1 month)
- Direct medical costs(Up to 1 year)
- R0 resection rate(Up to 1 month)
- Anal continence(Up to 1 year)
- Fecal incontinence quality of life (FIQL)(Up to 1 year)
- En bloc resection rate(Up to 1 month)
- Local recurrence(Up to 3 years)
- Time to resume normal diet(Up to 1 month)
- Quality of life measured by the Short Form-36 (SF-36) Health Survey questionnaire(Up to 1 year)
研究者
Simon S. M. Ng
Professor of Surgery
Chinese University of Hong Kong