Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- 3-year recurrence rate — 3 years postoperatively
- Successful sentinel lymph node biopsy — Intraoperative
Percentage of patients undergoing a successful sentinel lymph node biopsy with one or more sentinel lymph nodes detected
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Meander Medisch Centrum | Amersfoort | Netherlands | Recruiting |
More Meander Medical Center trials in the Netherlands
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06652672 on ClinicalTrials.gov ↗ ← All trials in the Netherlands