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

NCT06652672 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 341

Last updated 2025-11-20

No results posted yet for this 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.

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)

Interventions

PROCEDURE

Organ-sparing surgery

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

PROCEDURE

Standard of care segmental resection

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

Sponsors & Collaborators

  • Meander Medical Center

    lead OTHER

Principal Investigators

  • Frank J Voskens · Meander Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-12
Primary Completion
2030-12-12
Completion
2032-12-12

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06652672 on ClinicalTrials.gov