Ireland
--:--IST
Recruiting Not applicable

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

NCT06652672 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Meander Medical Center
Phase
Not applicable
Started
2024-12-12
Last updated
2025-11-20

Condition(s) studied

Colon CancerColon AdenocarcinomaSentinel Lymph NodeSentinel Lymph Node BiopsyColon NeoplasmsColon NeoplasmFluorescenceFluorescence Guided SurgeryFluorescence LaparoscopyFluorescence-guided ResectionColon SurgeryIndocyanine Green (ICG)

Investigational drug(s) / intervention(s)

Organ-sparing surgeryStandard of care segmental resection

Organ-sparing surgery: Endoscopy-assisted laparoscopic/robotic wedge resection and sentinel lymph node biopsy using submucosal injection of ICG.

Standard of care segmental resection: Standard of care segmental resection of the affected part of the colon including removal of regional lymph nodes.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 3-year recurrence rate — 3 years postoperatively
  • Successful sentinel lymph node biopsy — Intraoperative
    Percentage of patients undergoing a successful sentinel lymph node biopsy with one or more sentinel lymph nodes detected

Trial sites (1)

FacilityCityRegionStatus
Meander Medisch Centrum Amersfoort Netherlands Recruiting

More Meander Medical Center trials in the Netherlands

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06652672 on ClinicalTrials.gov ↗ ← All trials in the Netherlands