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

Study acronym: SENTRY
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Enrollment target: 325 to 341
    • Eligibility criteria expanded, about 14 words
    • Study description expanded, about 64 words
    v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Nov 1, 2030 to Dec 12, 2030
    • Study completion date: Nov 1, 2032 to Dec 12, 2032
    • Start date changed from estimate of Nov 1, 2024 to Dec 12, 2024
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06652672
Lead Sponsor Meander Medical Center
Conditions
(from sponsor)		 Colon Cancer, Colon Adenocarcinoma, Sentinel Lymph Node, Sentinel Lymph Node Biopsy, Colon Neoplasms, Colon Neoplasm, Fluorescence, Fluorescence Guided Surgery +4 more
Related terms Colonic Neoplasms
Enrollment 341 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov