Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR (SCAR)
Treatment Side Effects, Colorectal Cancer
About this trial
This is an interventional treatment trial for Treatment Side Effects
Eligibility Criteria
Inclusion Criteria: 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-B3. 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 prior surgical colorectal resection 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 Exclusion Criteria: all who do not fulfill inclusion criteria
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Surgery
EFTR (Endoscopic Full-Thickness Resection)
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.
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.