Actively Recruiting
Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma
Led by Meander Medical Center · Updated on 2025-11-20
341
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided oral and written informed consent
- Aged 18 years or older
- Fit for both organ-sparing surgery and colectomy
- Pathologically confirmed T1-2 adenocarcinoma of the colon after endoscopic resection with an estimated lymph node metastasis risk over 15%, or a lesion suspected to be T1 colon cancer smaller than 40 mm suitable for wedge resection
- Resection scar clearly visible at endoscopy by tattoo or scar in the colon segment without other polypectomies
- Lesion located more than 25 cm from the anus or above the sigmoid take-off based on endoscopy measurement
You will not qualify if you...
- Choosing active follow-up instead of surgery after shared decision-making
- Presence of distant metastasis
- Diagnosis of Lynch syndrome
- Another active cancer requiring palliative treatment at diagnosis
- Previous colorectal cancer within the last 5 years
- Tumors occupying more than 50% of the colon circumference before resection
- Tumors involving the ileocaecal valve
- Pregnancy, breastfeeding, or planned pregnancy during the study
- Known allergy to compounds used for sentinel lymph node identification (indocyanine green, iodine, or sodium iodide)
- Previous colon surgery (except appendectomy)
- Contraindications for laparoscopic or robotic surgery
- Severe kidney or liver failure
- Hyperthyroidism or autonomously functioning thyroid adenoma
AI-Screening
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Trial Site Locations
Total: 1 location
1
Meander Medisch Centrum
Amersfoort, Netherlands
Actively Recruiting
Research Team
B
Bart CT van de Laar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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