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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMeander Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Organ-sparing surgery
  • Standard of care segmental resection

Treatment groups

341 Participants
are divided into 2 treatment groups

Sponsors and collaborators