*A pilot study to assess the safety and feasibility of fluorescent sentinel lymph node identification in colon carcinoma using Indocyanine green and nanocolloid*

Completed

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

• Registration Number: NL-OMON49141
• Lead Sponsor: Meander Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-12-01
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

- Oral and written informed consent (IC)
- Aged 18 years and older
- Pathologically confirmed and/or suspected colon carcinoma

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome parameters are identification rate of SLN with<br /><br>ICG-nanocolloid, defined as the number of patients with one or more SLNs<br /><br>identified/total number of procedures, secondly the rate of adverse events<br /><br>related towards ICG-nanocolloid will be measured. This is defined as the number<br /><br>of adverse events related towards ICG-nanocolloid/total number of procedures.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome parameters include: False negative SLNs, true negative SLNs,<br /><br>sensitivity, specificity, upstaged patients, aberrant lymph node status,<br /><br>accuracy, negative predictive value and number of SLNs identified. </p><br>