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

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

Trial Details

NCT ID
NCT06652672
Phase
NA
Sponsor
Meander Medical Center
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • Organ-sparing surgery
  • Standard of care segmental resection
Locations (sample)
  • Amersfoort, Netherlands|52.155,5.3875

Key Eligibility Criteria

  • Oral and written informed consent (IC)
  • Aged 18 years and older
  • Fit for both organ-sparing surgery and colectomy
  • Pathologically confirmed T1-2 adenocarcinoma of the colon following R0, R1, or Rx endoscopic resection with an estimated LNM risk \>15% (Table 5.2.…

For full eligibility, visit ClinicalTrials.gov.

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