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

Recruiting now · Not applicable

Conditions studied: Colon Cancer, Colon Adenocarcinoma, Sentinel Lymph Node, Sentinel Lymph Node Biopsy, Colon Neoplasms, Colon Neoplasm, Fluorescence, Fluorescence Guided Surgery, Fluorescence Laparoscopy, Fluorescence-guided Resection, Colon Surgery, Indocyanine Green (ICG)

In brief

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.

Key facts

Study ID

NCT06652672

Run by

Meander Medical Center

People needed

341

Starts

2024-12-12

Expected to finish

2032-12-12

Last updated by the study team

2025-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 5.2.2. in module 5.2 of the Dutch CRC guideline); or a lesion macroscopically suspected to be (deep-invasive) T1 colon cancer, measuring <40 mm, for which wedge resection is considered the most suitable local resection technique as recommended by the MDT
• The resection scar after local excision is expected to be clearly recognized at endoscopy, either by a tattoo or by detecting a scar in the colorectal segment where no other polypectomies were performed
• Lesion located >25cm from the anus based on endoscopic measurement, or above sigmoid take-off

You may not qualify if…

• Patients who opt for active follow-up instead of surgery following shared decision-making
• Distant metastasis
• Lynch syndrome
• Another active malignancy requiring palliative treatment at the time of colon cancer diagnosis
• Previous colorectal cancer within the last 5 years
• Tumours that comprised >50% of the colon circumference before resection
• Tumours involving the ileocaecal valve
• Pregnancy, lactation or a planned pregnancy during the course of the study
• Known allergy to any of the compounds used for SLN identification (ICG, Iodine or Sodium iodide)
• Previous colonic surgery (excluding appendectomy)
• Contra-indication for laparoscopic or robotic surgery
• Severe kidney- or liver failure
• Hyperthyroidism or an autonomously functioning thyroid adenoma

Where it is running

• Meander Medisch Centrum — Amersfoort, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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