Fluorescence-guided (Minimally Invasive) resections of Colorectal liver metastases - II (MIMIC-II)
Phase 4
Recruiting
- Conditions
- colorectal liver metastasesmetastases in the liver from primary colon cancer1001981510019818
- Registration Number
- NL-OMON56540
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 52
Inclusion Criteria
• Receiving open or robotic surgery for (multiple) colorectal liver metastases
• Eligible for indocyanine green infusion • Pretreated with neoadjuvant
chemotherapy (received last cycle of chemotherapy within 3 months before
surgery) • Received at least 3 cycles of chemotherapy • Above 18 years of age
Exclusion Criteria
• Diagnosed with anything other than colorectal liver metastases after
histological examination
• Known allergy to indocyanine green
• Known allergies to shells and/or clamps
• Receiving other types of surgery then open and robotic surgery
• Contraindication for indocyanine green (EGFR <30; hyperthyroidism; pregnancy;
allergy to iodine, clams and/or shellfish; known allergy for indocyanine green)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Back-table signal-to-background ratio in bread loaves</p><br>
- Secondary Outcome Measures
Name Time Method <p>Back-table mean fluorescence intensity of signal fluorescence in bread loaves<br /><br>Back-table mean fluorescence intensity of background fluorescence in bread<br /><br>loaves<br /><br>Back-table width of the fluorescent *rim* in bread loaves<br /><br>In vivo signal-to-background ratios<br /><br>Radical resection rates<br /><br>Intraoperative visibility of the lesion(s) based on intraoperative<br /><br>questionnaires<br /><br>- For robotic surgery: Difference between interpretability of the fluorescence<br /><br>in *normal* Firefly mode and in *sensitive* Firefly mode based on<br /><br>intraoperative questionnaires.<br /><br>IHC scoring of Chemotherapy Associated Liver Injury (CALI) and liver function<br /><br>blood analysis<br /><br>Lifetime imaging, IHC, and bread loaf fluorescence correlation</p><br>