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Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma
Sponsor: Meander Medical Center
Summary
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.
Official title: Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma (SENTRY Trial)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
341
Start Date
2024-12-12
Completion Date
2032-12-12
Last Updated
2025-11-20
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Meander Medisch Centrum
Amersfoort, Netherlands