Organ-Sparing Surgery with Sentinel Lymph Node Biopsy Versus Standard Segmental Resection for Early Stage I Colon Cancer

What this Trial Is About

Researchers are evaluating a new surgical approach to reduce the need for colectomy and its associated risks in patients with early-stage pT1-2 colon cancer who have a higher risk greater than 15% of lymph node metastasis or suspected T1 tumors. This study compares an organ-sparing surgery involving an endoscopy-assisted laparoscopic or robotic wedge resection with sentinel lymph node biopsy using indocyanine green ICG to the standard segmental colon resection. The goal is to assess whether this less invasive method can safely reduce complications and improve patient outcomes over three years. The organ-sparing surgery involves removing just the tumor or scar tissue with the help of endoscopic visualization and performing a sentinel lymph node biopsy to check for cancer spread. If cancer is detected in the lymph nodes or if tumors are more advanced T3-4, patients receive the standard segmental resection and may be offered chemotherapy if suitable. Those with negative sentinel nodes avoid further surgery and are closely monitored. The comparison group undergoes the standard removal of a colon segment including regional lymph nodes. This trial uses a partially randomized design to compare these two methods. Participants will be closely followed with several assessments including imaging, pathology, and quality of life questionnaires over a period of up to five years. The main measure is the rate of cancer recurrence three years after surgery. Researchers will also track survival rates, complications within 90 days, procedure times, and detailed quality of life outcomes during and after treatment. The study aims to balance effective cancer control with reduced surgical risks and improved recovery experiences for patients.

Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma