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Intra-operatieve fluorescente beeldvorming alvleesklier tumoren en galwegen.

Intra-operative fluorescent imaging of pancreatic cancer and extra-hepatic bile ducts.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON24019
Enrollment
15
Registered
2010-02-12
Start date
2010-02-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer, pancreas, bile ducts

Interventions

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 usi

Sponsors

Leiden University Medical Center (LUMC)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with pancreatic cancer eligible to undergo a curative resection; 2. Age between 18 and 80 years old.

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
Primary outcome parameter is the number of identified pancreatic tumors.

Secondary

MeasureTime frame
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.

Contacts

Public ContactC.J.H. Velde, van de

Leiden University Medical Center (LUMC), Department of Surgical Oncology, P.O. Box 9600

c.j.h.van_de_velde@lumc.nl+31 (0)71 5262309

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)