Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma (SENTRY Trial)
The aim of this study is to reduce the need for segmental colonic resection and its associated morbidity and mortality in patients with high-risk pT1 and low-risk pT2 colon cancer following endoscopic resection, by performing an endoscopic-assisted laparoscopic/robotic wedge resection of the residual tumor or scar, along with sentinel node biopsy using indocyanine green (ICG). This intervention will be compared to the standard-of-care segmental resection using a partially randomized patient preference design. The primary outcome is the 3-year recurrence rate.
• Oral and written informed consent
• Aged 18 years and older
• Fit for both organ-sparing surgery and colectomy
• Pathologically confirmed high-risk T1 or low-risk T2 adenocarcinoma of the colon after R0/R1/Rx endoscopic resection
• The resection scar after local excision is expected to be clearly recognized during endoscopy, either by a tattoo or by detecting a scar in the colonic segment where no other polypectomies were performed
⁃ High-risk features for T1-T2 colorectal carcinoma are:
• Poor differentiation grade or undifferentiated (WHO classification of tumors: exhibits glandular structures in \<50%)
• Positive tumour budding (tumour budding grade 2-3)
• Presence of lymphovascular invasion (The presence of cancer cells within endothelial-lined channels)