Comparing Surgery and Endoscopic Full-Thickness Resection for Early Colon Cancer Removed Incompletely

What this Trial Is About

Researchers are conducting a randomized trial comparing two treatments for patients who have undergone incomplete endoscopic removal of early colon cancer. The study aims to evaluate the benefits, potential harms, burdens, environmental impact, and cost-effectiveness of endoscopic full thickness resection eFTR, a minimally invasive procedure using a colonoscope, compared to standard surgery. The main goals are to assess serious adverse events within 30 days and colon cancer recurrence or spread to lymph nodes or distant sites at 3 years after treatment. Participants are randomly assigned to one of two groups. One group receives surgery following current guidelines, which may include open, laparoscopic, or robotic segmental bowel resection targeting the lymphatic drainage area of the cancer. The other group undergoes eFTR using approved devices, where the scar from the previous removal is identified, documented, and then removed en bloc with the eFTR device mounted on the colonoscope. This design allows a direct comparison of these two approaches. During the study, participants will be closely monitored for safety, cancer recurrence, and other outcomes. Assessments include tracking severe adverse events within 30 days, cancer status at 1, 3, and 5 years, quality of life and functional outcomes, length of hospital stay, readmission rates, and environmental footprint of the procedures. The study also measures technical success and procedure duration. Overall, the trial lasts several years to fully evaluate long-term cancer control and safety.

Surgery Versus Endoscopic Resection for Incompletely Removed Early Colon CAnceR