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Real-time intraoperatieve nabij-infrarode fluorescentie cholangiografie tijdens laparoscopische cholecystectomie.


- candidate number13714
- NTR NumberNTR3686
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-nov-2012
- Secondary IDsP10.001 METC LUMC
- Public TitleReal-time intraoperatieve nabij-infrarode fluorescentie cholangiografie tijdens laparoscopische cholecystectomie.
- Scientific TitleIntra-operative fluorescent imaging of bile ducts during laparoscopic cholecystecomy.
- ACRONYMGREEN LIGHT
- hypothesisFluorescent near-infrared imaging can accurately detect bilary antomy during laparoscopic cholecystectomy.
- Healt Condition(s) or Problem(s) studiedCholecystolithiasis
- Inclusion criteria1. Patients scheduled to undergo laparoscopic cholecystectomy;METC LUMC 2. Age above 18.
- Exclusion criteria1. History of allergy to iodine, shellfish, indocyanine green, human serum albumin and/or history of hyperthyroidism or severe renal impairment;METC LUMC 2. Patient pregnant or lactating.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mrt-2012
- planned closingdate1-mrt-2013
- Target number of participants15
- InterventionsStandard laparoscopic cholecystecomy will be performed. During surgery, the near-infrared dye ICG will be injected and the bile ducts will be visualized non-invasively using a laparoscopic camera system.
- Primary outcomePrimary outcome parameter is the number of identified bile ducts.
- Secondary outcomeSecundary parameters are the signal-to-background ratios measured in patients that recieved ICG, and the number of identified structures of the biliray tree.
- TimepointsThe primary and secondary outcomes will be assessed during surgery.
- Trial web siteN/A
- statusopen: patient inclusion
- 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)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryDuring laparoscopic cholecystectomy, common bile duct injury is a rare but severe complication. Optical imaging using near-infrared (NIR) fluorescence has recently been introduced to reduce the risk of injury by real time visual guidance. The aim of the current study is to optimize dose and timing of ICG for near-infrared cholangiography using laparoscopic fluorescence imaging system.
- Main changes (audit trail)
- RECORD5-nov-2012 - 14-nov-2012


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