The main objective of this study is to determine the added value of NIR fluorescence imaging in patients with pancreatic cancer undergoing SL and to identify predictors for patients that may benefit from SL.
ID
Source
Brief title
Condition
- Endocrine gland therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Percentage of averted laparotomies.
Secondary outcome
- 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).
Background summary
Even after extensive preoperative assessment, up to 38% of patients undergoing
laparotomy with curative intent turn out to have metastases or unresectable
disease, preventing curative surgery. Moreover, a substantial number of
patients present shortly after surgery with liver metastases that must have
been present during surgery, but have not been identified. By addition of NIR
fluorescence imaging to SL and LUS more metastases might be identified, sparing
patients with incurable disease the morbidity, inconvenience and expense of a
futile operation.
Study objective
The main objective of this study is to determine the added value of NIR
fluorescence imaging in patients with pancreatic cancer undergoing SL and to
identify predictors for patients that may benefit from SL.
Study design
A phase II single center, single-arm trial to assess the added value of staging
laparoscopy (SL), laparoscopic ultrasonography (LUS) and near-infrared (NIR)
fluorescence imaging in patients with pancreatic cancer undergoing resection
with curative intent.
Intervention
Intravenous injection of 5 or 10 mg ICG 30 minutes to 24 hours prior to
surgery.
Study burden and risks
Patients will be asked to attend to the hospital 1-3 days prior to surgery.
They will receive an intravenous injection of 10 mg of ICG. This will take
approximately 30 minutes, whereafter patients can go home again.
Albinusdreef 2
Leiden 2300 RC
NL
Albinusdreef 2
Leiden 2300 RC
NL
Listed location countries
Age
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
- 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
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30732.058.09 |