Actively Recruiting
Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma Comparing Endoscopy-assisted Wedge Resection with Standard Segmental Resection
Led by Meander Medical Center · Updated on 2025-11-20
341
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new surgical approach to reduce the need for colectomy and its associated risks in patients with early-stage (pT1-2) colon cancer who have a higher risk (greater than 15%) of lymph node metastasis or suspected T1 tumors. This study compares an organ-sparing surgery involving an endoscopy-assisted laparoscopic or robotic wedge resection with sentinel lymph node biopsy using indocyanine green (ICG) to the standard segmental colon resection. The goal is to assess whether this less invasive method can safely reduce complications and improve patient outcomes over three years. The organ-sparing surgery involves removing just the tumor or scar tissue with the help of endoscopic visualization and performing a sentinel lymph node biopsy to check for cancer spread. If cancer is detected in the lymph nodes or if tumors are more advanced (T3-4), patients receive the standard segmental resection and may be offered chemotherapy if suitable. Those with negative sentinel nodes avoid further surgery and are closely monitored. The comparison group undergoes the standard removal of a colon segment including regional lymph nodes. This trial uses a partially randomized design to compare these two methods. Participants will be closely followed with several assessments including imaging, pathology, and quality of life questionnaires over a period of up to five years. The main measure is the rate of cancer recurrence three years after surgery. Researchers will also track survival rates, complications within 90 days, procedure times, and detailed quality of life outcomes during and after treatment. The study aims to balance effective cancer control with reduced surgical risks and improved recovery experiences for patients.
CONDITIONS
Brief Title
Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide oral and written informed consent
- Aged 18 years or older
- Fit for both organ-sparing surgery and colectomy
- Pathologically confirmed T1-2 colon adenocarcinoma after endoscopic resection with an estimated lymph node metastasis risk greater than 15% or a lesion suspected to be deep-invasive T1 colon cancer measuring less than 40 mm
- Resection scar clearly visible at endoscopy by tattoo or scar detection
- Lesion located more than 25 cm from the anus or above the sigmoid take-off based on endoscopic measurement
You will not qualify if you...
- Patients opting for active follow-up instead of surgery
- Presence of distant metastasis
- Diagnosis of Lynch syndrome
- Another active malignancy requiring palliative treatment at colon cancer diagnosis
- Previous colorectal cancer within the last 5 years
- Tumors involving more than 50% of the colon circumference before resection
- Tumors involving the ileocaecal valve
- Pregnancy, lactation, or planned pregnancy during the study
- Known allergy to compounds used for sentinel lymph node identification (ICG, iodine, or sodium iodide)
- Previous colonic surgery (except appendectomy)
- Contraindication for laparoscopic or robotic surgery
- Severe kidney or liver failure
- Hyperthyroidism or autonomously functioning thyroid adenoma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single surgical procedure with immediate intraoperative assessments
Participants undergo either organ-sparing surgery with endoscopy-assisted wedge resection and sentinel lymph node biopsy or standard segmental resection of the affected colon.
1 surgical procedure visit (in-person)
Duration - Up to 5 years postoperatively
Participants are monitored postoperatively with quality of life questionnaires and clinical assessments to evaluate recurrence, complications, and survival.
Scheduled visits and questionnaires at multiple timepoints through 5 years postoperatively
Trial Site Locations
Total: 1 location
1
Meander Medisch Centrum
Amersfoort, Netherlands
Actively Recruiting
Research Team
B
Bart CT van de Laar
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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