Pancreatic and periampullary cancer
Conditions
Interventions
In addition to standard-of-care, patients will receive an intravenous injection of 10 mg ICG 1-3 days prior to surgery. During surgery, patients undergo a SL, whereupon inspection, LUS and NIR fluores
Sponsors
Leiden University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: - 18 years or older; - Patients with pancreatic or periampullary cancer undergoing resection with curative intent; - Stage 2A or higher; or tumor sized 3 cm or more; - 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; - 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. | — |
Contacts
Public ContactSven Mieog
Outcome results
None listed