Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma
Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma (SENTRY Trial)
Meander Medical Center
341 participants
Dec 12, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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
Exclusion Criteria13
- Patients who opt for active follow-up instead of surgery following shared decision-making
- Distant metastasis
- Lynch syndrome
- Another active malignancy requiring palliative treatment at the time of colon cancer diagnosis
- Previous colorectal cancer within the last 5 years
- Tumours that comprised \>50% of the colon circumference before resection
- Tumours involving the ileocaecal valve
- Pregnancy, lactation or a planned pregnancy during the course of the study
- Known allergy to any of the compounds used for SLN identification (ICG, Iodine or Sodium iodide)
- Previous colonic surgery (excluding appendectomy)
- Contra-indication for laparoscopic or robotic surgery
- Severe kidney- or liver failure
- Hyperthyroidism or an autonomously functioning thyroid adenoma
Interventions
Endoscopy-assisted laparoscopic/robotic wedge resection and sentinel lymph node biopsy using submucosal injection of ICG.
Standard of care segmental resection of the affected part of the colon including removal of regional lymph nodes.
Locations(1)
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NCT06652672