Could a smaller surgery be just as safe for early colon cancer?
NCT ID NCT06652672
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a less invasive surgery for people with early-stage colon cancer (stage I). Instead of removing a large section of the colon, doctors will remove only the tumor and a few nearby lymph nodes using a special dye. The goal is to see if this smaller surgery works as well as standard surgery, with fewer side effects. About 341 adults will take part, and researchers will track cancer return rates over 3 years.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 341 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Dec 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Meander Medisch Centrum
RECRUITINGAmersfoort, Netherlands
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