RecruitingNot ApplicableNCT06652672

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

Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma (SENTRY Trial)

Sponsor

Meander Medical Center

Enrollment

341 participants

Start Date

Dec 12, 2024

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether organ-sparing (less invasive) surgery guided by sentinel lymph node mapping can be a safe alternative to the standard full colon removal (colectomy) in patients with early-stage colon cancer (stage I) after initial endoscopic removal of a polyp. **You may be eligible if...** - You are 18 or older with a confirmed early-stage colon cancer (T1 or T2 adenocarcinoma) - Your cancer was found during a colonoscopy and removed endoscopically, but additional surgery is recommended due to risk of lymph node spread - You are fit enough to undergo either type of surgery **You may NOT be eligible if...** - Your cancer is more advanced (stage T3 or higher) - You have had previous colon surgery that would interfere with the procedure - You have certain other serious medical conditions - You are unwilling to accept either surgical option Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREOrgan-sparing surgery

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

PROCEDUREStandard of care segmental resection

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

Locations(1)

Meander Medisch Centrum

Amersfoort, Netherlands

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NCT06652672

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