Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR (SCAR)- a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 304
- 试验地点
- 3
- 主要终点
- CRC recurrence or sign of lymph nodes or distant metastases
研究概览
简要总结
Randomized head-to-head comparison trial among patients who have undergone incomplete endoscopic resection of early colon cancer to evaluate the benefits, harms and burdens, as well as the ecological footprint and cost-effectiveness of endoscopic full thickness resection (eFTR), a minimally invasive endoscopic treatment with a colonoscope, as compared to standard-of-care surgery.
Co-primary endpoints are
- Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 30-days after study treatment
- CRC recurrence or sign of lymph nodes or distant metastases at 3 years after randomization comparing the two treatment groups (eFTR versus surgery).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, age 40 years or older with endoscopic removal (snare or forceps polypectomy; endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) with R1 (resection margin <0.1mm23,40) or Rx resection margins of colon cancer (location proximal to the rectum (12 cm or more from the anal verge))
- •No contraindication for colon surgery as deemed by the multidisciplinary tumor board (MTB) at the participating centre
- •Absence of the following histopathological tumor features: poor differentiation, lymphovascular invasion, tumor budding grade B2-B
- •No sign of disease beyond stage T1N0M0 on standard-of-care computed tomography imaging of the thorax, abdomen and pelvis41 and clinical evaluation
- •Identifiable resection site with colonoscopy, either by visualizing a previously administered tattoo or by identification of a scar in the correct colon segment
- •No other tumors or polyps larger than 10 mm in diameter in the colorectum at time of randomization
- •Complete colonoscopy with adequate quality of bowel preparation (Boston Bowel Preparation Scale score ≤2 in all colonic segments) and photo or video documentation of the appendiceal orifice or ileocecal valve.
- •No colonic strictures or severe diverticulosis.
- •No prior CRC
- •No other malignant disease which is not deemed cured
- •No confirmed or suspected genetic cancer syndrome (10 or more adenomas/serrated lesions, adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
- •No inflammatory bowel disease
- •Written informed consent provided by before enrolment
排除标准
- •all who do not fulfill inclusion criteria
研究组 & 干预措施
Surgery
Patients randomized to surgery are treated according to current guidelines with either open, laparoscopic or robotic surgical segmental bowel resection corresponding to lymphovascular drainage of the cancer.
干预措施: Tumor removal (Procedure)
EFTR (Endoscopic Full-Thickness Resection)
Patients randomised to EFTR are treated using devices approved for eFTR in the European Union and affiliated countries for the indication as applied in the trial. Before EFTR, the scar is identified and documented. The colonoscope is then removed, the EFTR device mounted, the colonoscope re-introduced, and eFTR performed.
干预措施: Tumor removal (Procedure)
结局指标
主要结局
CRC recurrence or sign of lymph nodes or distant metastases
时间窗: 3 years
Rate of CRC recurrence or sign of lymph nodes or distant metastases
Severe adverse events
时间窗: 30 days
Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 30-days after study treatment
次要结局
- CRC survival and overall survival at 1,3 and 5 years after study treatment(1, 3, 5 years)
- Duration of the study procedure(1 day)
- Length of hospital stay after study treatment(30 days)
- Hospital readmission rate after discharge within 30 days after study treatment(30 days)
- Technical success of the trial procedures, defined as completion of eFTR and surgery as planned with endoscopic complete en-bloc scar excision or complete surgical resection(1 day)
- CRC recurrence or sign of lymph nodes or distant metastases at 1 year after study treatment(1 year)
- CRC recurrence or sign of lymph nodes or distant metastases at 5 years after study treatment(5 years)
- Rate of severe adverse events classified as grade III to V according to the Clavien Dindo classification within 1 year after study treatment(1 year)
- Rate of mild and moderate adverse events classified as grade I and II according to the Clavien Dindo classification at 30 days after study treatment(30 days)
- Health related quality of life and functional outcomes after 30 days and one year(30 days, 1 year)
- Environmental footprint of study procedures at 30 days after study treatment(30 days)
研究者
Michael Bretthauer
Co-Principal Investigator
Norwegian Department of Health and Social Affairs