Sentinel node and organ sparing surgery in stage I colon carcinoma (SENTRY trial)

• Conditions: colon cancer; colon carcinoma; 10017990; 10017991; 10017998

• Registration Number: NL-OMON56976
• Lead Sponsor: Meander Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 325

Inclusion Criteria

- Oral and written informed consent (IC)
- Aged 18 years and older
- Fit for both organ-sparing surgery and colectomy
- Pathologically confirmed high-risk T1 or low-risk T2 adenocarcinoma of the
colon after R0/R1/Rx endoscopic resection
- 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
High-risk features for T1-T2 colorectal carcinoma are:
- Poor differentiation grade or undifferentiated (WHO classification of
tumours: exhibits glandular structures in <50%)
- Positive tumour budding (tumour budding grade 2-3)
- Presence of lymphovascular invasion (The presence of cancer cells within
endothelial-lined channels)

Exclusion Criteria

- Lesion located <25cm from the anus based on endoscopic measurement
- Distant metastasis
- Mucinous or signet ring cell carcinoma
- Lynch syndrome
- Other primary malignancy treated within 5 years prior to diagnosis of colon
cancer, except for curatively treated prostate, breast, skin and cervical cancer
- Tumours that comprised >50% of the colon circumference before endoscopic
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified