Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR

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).

NCT Number	NCT06057350
Lead Sponsor	Norwegian Department of Health and Social Affairs Collaborators: Hôpital Edouard Herriot, Maria Sklodowska-Curie National Research Institute of Oncology, Nuovo Regina Margherita Hospital, Karolinska Institutet, Humanitas Clinical and Research Center, Medical University of Gdansk, Universitätsklinikum Hamburg-Eppendorf, University Hospital, Akershus, Vestre Viken Hospital Trust, University Hospital of North Norway, Helse Stavanger HF, Oslo University Hospital
Conditions	Treatment Side Effects, Colorectal Cancer
Enrollment	304 participants
Start Date	2023-10-27
Primary Completion	2031-09 (estimated)
Study Completion	2033-09 (estimated)
Updated on ClinicalTrials.gov	2024-02-16