Identification of the sentinel lymph node (SLN) in patients with colon carcinoma.

Phase 1

• Conditions: Colon carcinoma; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2019-003179-20-NL
• Lead Sponsor: Meander Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-23
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

- Oral and written informed consent (IC)
- Aged 18 years and older
- Pathologically confirmed and/or suspected colon carcinoma
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 5

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess safety and feasibility of SLN identification using submucosal peritumoral ICG injections.;Secondary Objective: - Assessing detection rate of SLN identification<br>- Assessing sensitivity of SLN identification <br>- Assessing the incidence of micrometastases after ultrastaging <br>- Assessing adverse reactions towards ICG;Primary end point(s): -Identification rate of SLN with ICG<br>-Number of adverse or allergic reactions towards ICG<br>;Timepoint(s) of evaluation of this end point: Identification ration will be assesed intra-operatively<br>Number of adverse/allergic events will be assessed intra and post-operatively

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -False negative SLN rate<br>-Sensitivity of SLN <br>-Number of patients who are upstaged by ultrastaging techniques<br>-Number and status of aberrant lymph nodes<br>-Accuracy: conformity of the SLN status and the regional node status<br>;Timepoint(s) of evaluation of this end point: All secondary endpoints will be collected postoperatively, after pathological assessment is completed.