No registrations found.
ID
Source
Brief title
Health condition
Pancreatic cancer, pancreas, bile ducts
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome parameter is the number of identified pancreatic tumors.
Secondary outcome
Secundary parameters are the differences in tumor-to-background ratios measured in patients that recieved different amounts of ICG. Furthermore, the fluorescence of bile ducts on different time-points after injection. Another secundary outcome parameter is the lymfatic drainage pattern of a pancreatic tumor.
Background summary
Pancreatic cancer is the third leading cause of cancer-related death in the United States and Europe. Surgical resection is
the only available curative therapy. During pancreatic surgery, it is often hard to differentiate between malignant tissue and
benign tissue. In over 35% of cases, the resection margins appear to be positive. To reduce the numer of patients with
positive resection margins, near-infrared fluorescence imaging can be very usefull.
Standard Whipple procedure will be performed. During surgery, the near-infrared dye ICG will be injected and the pancreatic carcinoma and extra-hepatic bile ducts will be visualized non-invasively using our experimental camerasystem.
Study objective
Fluorescent near-infrared imaging can accurately detect pancreatic cancer non-invasively during a whipple procedure.
Study design
The primary and secondary outcomes will be assessed during surgery and pathological assessment.
Intervention
Standard Whipple procedure will be performed. During surgery, the near-infrared dye ICG will be injected and the pancreatic carcinoma and extra-hepatic bile ducts will be visualized non-invasively using our experimental camerasystem.
Department of Surgical Oncology,
P.O. Box 9600
C.J.H. Velde, van de
Leiden 2300 RC
The Netherlands
+31 (0)71 5262309
c.j.h.van_de_velde@lumc.nl
Department of Surgical Oncology,
P.O. Box 9600
C.J.H. Velde, van de
Leiden 2300 RC
The Netherlands
+31 (0)71 5262309
c.j.h.van_de_velde@lumc.nl
Inclusion criteria
1. Patients diagnosed with pancreatic cancer eligible to undergo a curative resection;
2. Age between 18 and 80 years old.
Exclusion criteria
1. No History of allergy to iodine, shellfish, indocyanine green, human serum albumin and/or history of hyperthyroidism or severe renal impairment;
2. Patient pregnant or lactating.
Design
Recruitment
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 |
|---|---|
| NTR-new | NL2097 |
| NTR-old | NTR2214 |
| Other | METC LUMC : P10.001 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |