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

Launched by MEANDER MEDICAL CENTER · Oct 18, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat early-stage colon cancer, specifically high-risk T1 and low-risk T2 adenocarcinoma, which is a type of cancer in the colon. The goal is to see if a less invasive surgery, called endoscopic-assisted laparoscopic or robotic wedge resection, can be as effective as the standard surgery, which removes a larger section of the colon. This new method uses a special dye called indocyanine green to help identify important lymph nodes during surgery, which may help reduce complications and recovery time. The researchers will track how many patients experience a return of cancer within three years after treatment.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with specific types of colon cancer that meet certain criteria. They should also be healthy enough to undergo either the new surgery or the standard one. Interested individuals will need to provide consent and have their cancer evaluated to see if they qualify. If they join the trial, they can expect to receive either the new approach or standard care, and they will be closely monitored by the medical team throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Oral and written informed consent
• • 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 during endoscopy, either by a tattoo or by detecting a scar in the colonic segment where no other polypectomies were performed
• High-risk features for T1-T2 colorectal carcinoma are:
• • Poor differentiation grade or undifferentiated (WHO classification of tumors: 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 carcinoma
• • 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).
• • Contraindication for laparoscopic or robotic surgery
• • Severe kidney- or liver failure
• • Hyperthyroidism or an autonomously functioning thyroid adenoma