NCT06652672Recruiting
Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma
Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma (SENTRY Trial)
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 341 (estimated)
- First submitted
- 8 Oct 2024
- Start date
- 12 Dec 2024
- Primary completion date
- 12 Dec 2030
- Lead sponsor
- Meander Medical Center
- Diseases
- Colorectal cancer
- NCT number
- NCT06652672
What you commit to
- Study type: Interventional
- Planned participants: 341
- From 12 Dec 2024 to the primary completion date, 12 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who opt for active follow-up instead of surgery following shared decision-making
- Previous colorectal cancer within the last 5 years
- Tumours that comprised \>50% of the colon circumference before resection
- Previous colonic surgery (excluding appendectomy)
- Contra-indication for laparoscopic or robotic surgery
Other illness
- Lynch syndrome
- Another active malignancy requiring palliative treatment at the time of colon cancer diagnosis
- Severe kidney- or liver failure
Lab values
- Known allergy to any of the compounds used for SLN identification (ICG, Iodine or Sodium iodide)
Other
- Distant metastasis
- Tumours involving the ileocaecal valve
- Pregnancy, lactation or a planned pregnancy during the course of the study
- Hyperthyroidism or an autonomously functioning thyroid adenoma
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Meander Medisch Centrum Coordinator of this site? Confirm its status | Amersfoort | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.