Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma
NCT06652672
Summary
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
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
Conditions13
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
NCT06652672