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Intraoperative bile duct visualisation in children with biliary atresia using a multispectral fluorescence camera system: pilot study.


- candidate number6894
- NTR NumberNTR2170
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-jan-2010
- Secondary IDsBA_BICG_UMCG_1 UMC Groningen
- Public TitleIntraoperative bile duct visualisation in children with biliary atresia using a multispectral fluorescence camera system: pilot study.
- Scientific TitleIntraoperative bile duct visualisation in children with biliary atresia using a multispectral fluorescence camera system: pilot study.
- ACRONYMFLUBA
- hypothesisThe diagnosis of biliary atresia may be confirmed by intraoperative fluorescence cholangiography using intravenously or biliary administered indocyanine green.
- Healt Condition(s) or Problem(s) studiedBiliary atresia
- Inclusion criteriaChildren in whom billiary atresia is suspected scheduled to undergo Kasai portoenterostomy.
- Exclusion criteria1. History of iodine allergy or anaphylactic reactions to insect bites or medication;
2. Presence or history of hyperthyroidism;
3. Severe renal or liver failure.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 21-jan-2010
- planned closingdate31-dec-2011
- Target number of participants4
- Interventions1. Intravenous injection with ICG;
2. Intrabiliary injection with ICG;
3. Imaging using a near-infrared fluorescence camera.

All children receive intravenous injection with ICG. If no signal is received peroperative, intrabillary injection is administered.
- Primary outcomeVisualisation of the (remnant) biliary structures.
- Secondary outcomeN/A
- TimepointsIntraoperative imaging.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD JBF Hulscher
- CONTACT for SCIENTIFIC QUERIESMD, PhD JBF Hulscher
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryConventional cholangiography in children with biliary atresia is a cumbersome procedure that is not always successful. Fluorescence cholangiography may provide a simpler, safer method of visualising the (remnant) extrahepatic bile ducts.
- Main changes (audit trail)
- RECORD19-jan-2010 - 7-feb-2010


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