Pancreatic cancer metastases secondary malignancies
Conditions
Interventions
Intravenous injection of 5 or 10 mg ICG 30 minutes to 24 hours prior to
surgery.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 18 years or older; - Patients with pancreatic or periampullary cancer undergoing staging laparoscopy - Absence of any psychological, familial sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial; - Before patient registration, written consent must be given according to ICH/GCP, national and local regulations.
Exclusion criteria
Exclusion criteria: - History of allergy to iodine, shellfish or ICG; - Renal impairment, defined as eGFR > 60; - Patients with hyperthyroidism; - Pregnant or lactating woman; - Any condition that in the opinion of the investigator could potentially jeopardize the health status of the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Percentage of averted laparotomies. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Sensitivity and positive predictive value of laparoscopic inspection vs. LUS vs. NIR fluorescence imaging vs. histopathological examination. - Positive and negative predictive value of LUS vs. NIR fluorescence imaging on the occurrence of distant metastases. - Distant disease-free survival (occurrence of distant metastases) - Overall survival - Perioperative morbidity and mortality. - Duration of surgical procedures. - Quality of life (EORTC QLQ-C30 taken during standard planned outpatient clinic visits every 3 months). | — |
Countries
Netherlands
Outcome results
None listed