NL-OMON51330
Completed
N/A
A pilot study to assess the safety and feasibility of fluorescent sentinel lymph node identification in colon carcinoma using submucosal bevacizumab-800CW - IBIZA-1(pilot)
Meander Medisch Centrum0 sites5 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Meander Medisch Centrum
- Enrollment
- 5
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Oral and written informed consent (IC)
- •\- Aged 18 years and older
- •\- Pathologically confinmed and/or suspected cT1\-3N0\-2M0 colon carcinoma
Exclusion Criteria
- •\- Distant metastasis
- •\- Suspicion of cT4 disease based on pre\-operative assessment
- •\- Metastatic or T4 disease discovered during intraoperative staging
- •\- Pregnancy, lactation or a planned pregnancy during the course of the
- •\- Previous colon surgery, excluding appendectomy.
- •\- Contra\-indication for laparoscopic/robotic surgery
- •\- Inadequately controlled hypertension with or without current antihypertensive
- •medication.
- •\- Within 6 months prior to inclusion: myocardial infarction, TIA, CVA,
- •pulmonary embolism, unstable angina pectoris, or uncontrolled chronic hepatic
Outcomes
Primary Outcomes
Not specified
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