Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma
Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma (SENTRY Trial)
About This Trial
The aim of this study is to reduce the need for colectomy and its' associated morbidity and mortality in patients with pT1-2 colon carcinoma after endoscopic resection and an estimated lymph node metastasis (LNM) risk of \>15%, or with macroscopically suspected T1 tumors, by performing an endoscopic-assisted laparoscopic/robotic wedge resection of the tumor or scar, along with sentinel node (SLN) 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.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
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Treatments Being Tested
Organ-sparing surgery
Endoscopy-assisted laparoscopic/robotic wedge resection and sentinel lymph node biopsy using submucosal injection of ICG.
Standard of care segmental resection
Standard of care segmental resection of the affected part of the colon including removal of regional lymph nodes.