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

Sponsor
Meander Medical Center
Study ID
NCT06652672
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Organ-sparing surgery — PROCEDURE
    Endoscopy-assisted laparoscopic/robotic wedge resection and sentinel lymph node biopsy using submucosal injection of ICG.
  • Standard of care segmental resection — PROCEDURE
    Standard of care segmental resection of the affected part of the colon including removal of regional lymph nodes.

Study Details

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.

Key Dates

First listed
Oct 22, 2024
Start date
Dec 12, 2024
Status verified
Nov 2025
Primary completion
Dec 12, 2030
Completion
Dec 12, 2032

Study Design

Enrollment
341 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Organ-sparing surgery
    Local resection with sentinel lymph node biopsy
  • Active Comparator: Standard of care segmental resection

Primary Outcome Measure

3-year recurrence rate [ Time Frame: 3 years postoperatively ]

Central Contacts

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