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

NCT06652672 | Recruiting DMC

• 1 other identifier: NL84875.100.23
• Study Type: interventional
• Target: 341
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colon Cancer; Colon Adenocarcinoma; Sentinel Lymph Node; Sentinel Lymph Node Biopsy; Colon Neoplasms; Colon Neoplasm; Fluorescence; Fluorescence Guided Surgery; Fluorescence Laparoscopy; Fluorescence-guided Resection; Colon Surgery; Indocyanine Green (ICG)

Keywords

Colon cancer; Fluorescence; Sentinel lymph node; Indocyanine green (ICG); Organ sparing surgery; Organ preserving surgery; Local resection

Outcome Measures

Primary Outcomes (2)

• 3-year recurrence rate

  3 years postoperatively

• Successful sentinel lymph node biopsy

  Percentage of patients undergoing a successful sentinel lymph node biopsy with one or more sentinel lymph nodes detected

  Intraoperative

Secondary Outcomes (19)

• 5-year recurrence rate

  5 years postoperatively

• 3-year overall survival

  3 years postoperatively

• 5-year overall survival

  5 years after postoperatively

• 90-days complication rate

  90 days postoperatively

• 90-days postoperative mortality

  90 days postoperatively

Study Arms (2)

Organ-sparing surgery

EXPERIMENTAL

Local resection with sentinel lymph node biopsy

Procedure: Organ-sparing surgery

Standard of care segmental resection

ACTIVE COMPARATOR

Procedure: Standard of care segmental resection

Interventions

Organ-sparing surgery PROCEDURE

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

Organ-sparing surgery

Standard of care segmental resection PROCEDURE

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

Standard of care segmental resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meander Medical Center: lead

Study Sites (1)

Meander Medisch Centrum

Amersfoort, Netherlands

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Frank J Voskens

  Meander Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bart CT van de Laar

CONTACT

+31338507137; bct.vande.laar@meandermc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. Esther Consten

Model Details: Multi-center, prospective, non-inferior, partially randomized patient-preference trial

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 22, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): December 12, 2030
• Study Completion (Estimated): December 12, 2032
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)