A pilot study to assess the safety and feasibility of fluorescent sentinel lymph node identification in colon carcinoma using Indocyanine green.
- Conditions
- cT1-T2 colon carcinoma
- Registration Number
- NL-OMON24349
- Lead Sponsor
- Meander Medical Centre, Department of Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
Oral and written informed consent (IC);
- Aged 18 years and older;
- Pathologically confirmed and/or suspected T1-T2 colon carcinoma without (suspected) lymph node metastases.
- Distant metastasis;
- cT3- T 4 disease based on pre-operative assessment;
- Metastatic or T 4 disease discovered during intraoperative staging;
- A tumour too large to pass endoscopically;
- Pregnancy, lactation or a planned pregnancy during the course of the study.
- Known allergy to any of the compound used for SLN identification (ICG, iodine or sodium iodide);
- Suspected or proven lymph node metastasis;
- Previous colon surgery;
- Contra-indication for robotic surgery;
- Ink marking close to the tumour;
- Severe kidney- or liver failure;
- Hyperthyroidism or an autonomously functioning thyroid adenoma.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Identification rate of SLN with ICG: Number of patients with one or more SLNs identified / total number of procedures (n, %).<br>2. Adverse events related towards ICG: Number of adverse events related towards ICG / total number of procedures (n, %).
- Secondary Outcome Measures
Name Time Method 3. False negative SLNs: The SLNs are negative whereas the non-sentinel nodes (NSNs) were positive (number).<br>4. True negative SLNs: Both the SLNs and NSNs are negative (number). <br>5. Sensitivity: The number of patients with a positive SLN / the total number of node positive patients (n, %).<br>6. Upstaging: The number of patients with SLNs positive for micro- or macrometastases by serial slicing and IHC / the number of patients who were node negative by H&E examination (n, %).<br>7. Aberrant lymph node status: The number of patients with aberrant lymph nodes, and the status of these lymph nodes considering micro- or macrometastases. <br>8. Accuracy: (The total number of patients with a positive SLN + the number of patients with a truenegative SLN) / number of patients with an identified SLN (n, %).