Minimally invasive surgery for early-stage colon cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to reduce the need for extensive segmental colonic resections in patients with high-risk pT1 and low-risk pT2 colon cancer by utilizing endoscopic-assisted laparoscopic or robotic wedge resection combined with sentinel node biopsy using indocyanine green (ICG). The approach will be compared to the standard segmental resection in a partially randomized patient preference design. The primary outcome measured will be the 3-year recurrence rate of cancer. This innovative method seeks to minimize surgical morbidity and improve patient quality of life.

Why it matters

Who can join: the full rules

Inclusion 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 5.2.2. 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

Exclusion Criteria:

* 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's running

• Meander Medisch Centrum
  Amersfoort, Netherlands Recruiting

Study contacts

• Principal investigator: Frank J Voskens — Meander Medical Center
• Study coordinator: Bart CT van de Laar
• Email: bct.vande.laar@meandermc.nl
• Phone: +31338507137

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.