colon carcinoma Intestinal cancer
Conditions
Interventions
1. Patients are identified at the outpatient clinic and asked for participation
in the study.
2. Patients will be planned for robot-assisted surgical colectomy according to
standard of care (SOC).
3
Sponsors
Meander Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Oral and written informed consent (IC) - Aged 18 years and older - Pathologically confirmed and/or suspected colon carcinoma
Exclusion criteria
Exclusion criteria: - Distant metastases - Suspicion of T3-T4 disease based on pre-operative assessment. - Metastatic or T4 disease discovered during intraoperative staging - A tumour too large to pass endoscopically - Pregnant patients - Known allergy to any of the compound used for SLN identification (ICG, Iodine) - Suspected or proven lymph node metastasis - Previous colon surgery - Contra-indication for robotic surgery - Ink marking close to the tumour
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome parameters are identification rate of SLN with ICG-nanocolloid, defined as the number of patients with one or more SLNs identified/total number of procedures, secondly the rate of adverse events related towards ICG-nanocolloid will be measured. This is defined as the number of adverse events related towards ICG-nanocolloid/total number of procedures. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome parameters include: False negative SLNs, true negative SLNs, sensitivity, specificity, upstaged patients, aberrant lymph node status, accuracy, negative predictive value and number of SLNs identified. | — |
Countries
Netherlands
Outcome results
None listed