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van CCT (UK)


Optimalization of real-time intraoperative near-infrared (NIR) fluorescence cholangiography during laparoscopic cholecystectomy


- candidate number23578
- NTR NumberNTR5623
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-jan-2016
- Secondary IDsP10.001 Addendum U
- Public TitleOptimalization of real-time intraoperative near-infrared (NIR) fluorescence cholangiography during laparoscopic cholecystectomy
- Scientific TitleFluorescence cholangiography: dose and time optimzation study
- ACRONYMGREEN LIGHT
- hypothesisDelayed fluorescence imaging is optimal for visualization of bile ducts compared to the surrounding liver.
- Healt Condition(s) or Problem(s) studiedBile ducts, Cholecystectomy
- Inclusion criteriaPatients (>18 years old) suffering from benign gallbladder pathology, planned to undergo laparoscopic cholecystectomy
- Exclusion criteria1. Allergy for jodide or indocyanine green;
2. Hyperthyroidism or autonomous thyroidal adenoma;
3. Pregnancy;
4. Severe renal impairment (eGFR<55)
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 13-nov-2014
- planned closingdate1-mrt-2016
- Target number of participants28
- InterventionsPatients will be divided in several groups and receive either 5 or 10 mg ICG, administered (iv)30 min, 2h, 4h, 6h or 24 hours prior to surgery. Standard laparoscopic cholecystectomy will be performed. Fluorescence imaging will be frequently performed during surgery using the Karl Storz HD fluorescence laparoscope.
- Primary outcome- Identification of bile ducts using laparoscopic NIR fluorescence imaging during laparoscopic cholecystectomy.
- Secondary outcome-Distinctive character of fluorescence imaging of bile ducts vs. liver after injection of either 5 or 10 mg ICG after several time points
-Evaluation of applicability of NIR fluorescence imaging during laparoscopic cholecystectomy by performing questionnaire after surgery
- TimepointsThe primary and secondary timepoints will be assessed during and after surgery
- Trial web sitewww.igos.nl
- 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 summaryBile duct identification during laparoscopic cholecystectomy can be challanging. Near-infrared fluroescence cholangiography is an innovative technique enabling real-time identification of bile duct anatomy after injection of the fluorophore indocyanine green (ICG).
However, distinction between liver and bile ducts is of utmost important to make this technique widely applicable and usefull. No optimal dose of ICG and time of administration have ever been investigated. In the current study, we aim to optimize both factors.
- Main changes (audit trail)
- RECORD7-jan-2016 - 27-feb-2016


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