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Clinical Trials/NL-OMON24349
NL-OMON24349
Recruiting
N/A

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

Meander Medical Centre, Department of Surgery0 sites10 target enrollmentTBD
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Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
Meander Medical Centre, Department of Surgery
Enrollment
10
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Meander Medical Centre, Department of Surgery

Eligibility 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

  • •\- 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;

Outcomes

Primary Outcomes

Not specified

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