cT1-T2 colon carcinoma
Conditions
Interventions
Patients will then undergo robot-assisted surgery, they will be prepped, draped and placed under general anesthesia. Robot-assisted access will be obtained in the traditional fashion and abdominal exp
Sponsors
Meander Medical Centre, Department of Surgery
Eligibility
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Identification rate of SLN with ICG: Number of patients with one or more SLNs identified / total number of procedures (n, %). 2. Adverse events related towards ICG: Number of adverse events related towards ICG / total number of procedures (n, %). | — |
Secondary
| Measure | Time frame |
|---|---|
| 3. False negative SLNs: The SLNs are negative whereas the non-sentinel nodes (NSNs) were positive (number). 4. True negative SLNs: Both the SLNs and NSNs are negative (number). 5. Sensitivity: The number of patients with a positive SLN / the total number of node positive patients (n, %). 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, %). 7. Aberrant lymph node status: The number of patients with aberrant lymph nodes, and the status of these lymph nodes considering micro- or macrometastases. 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, %). | — |
Contacts
Public ContactDaan Sikkenk
Meander Medisch Centrum
Outcome results
None listed