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Intra-operatieve fluorescente beeldvorming alvleesklier tumoren en galwegen.


- candidate number7759
- NTR NumberNTR2214
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-feb-2010
- Secondary IDsP10.001 METC LUMC
- Public TitleIntra-operatieve fluorescente beeldvorming alvleesklier tumoren en galwegen.
- Scientific TitleIntra-operative fluorescent imaging of pancreatic cancer and extra-hepatic bile ducts.
- ACRONYMGREEN LIGHT PANCREAS
- hypothesisFluorescent near-infrared imaging can accurately detect pancreatic cancer non-invasively during a whipple procedure.
- Healt Condition(s) or Problem(s) studiedPancreatic cancer, Bile ducts
- Inclusion criteria1. Patients diagnosed with pancreatic cancer eligible to undergo a curative resection;
2. Age between 18 and 80 years old.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2010
- planned closingdate1-jul-2010
- Target number of participants15
- InterventionsStandard 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.
- Primary outcomePrimary outcome parameter is the number of identified pancreatic tumors.
- Secondary outcomeSecundary 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.
- TimepointsThe primary and secondary outcomes will be assessed during surgery and pathological assessment.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESProf. Dr. C.J.H. Velde, van de
- CONTACT for SCIENTIFIC QUERIESMD PhD A.L. Vahrmeijer
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Center for Translational Molecular Medicine (CTMM)
- PublicationsN/A
- Brief summaryPancreatic 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.
- Main changes (audit trail)
- RECORD12-feb-2010 - 3-jan-2011


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