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Intraoperative visualisation of the extrahepatic bile ducts using near-infrared fluorescent imaging: A technical feasibility study.


- candidate number6435
- NTR NumberNTR1997
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-sep-2009
- Secondary IDsBICG04UMCG-NIRF UMC Groningen
- Public TitleIntraoperative visualisation of the extrahepatic bile ducts using near-infrared fluorescent imaging: A technical feasibility study.
- Scientific TitleIntraoperative visualisation of the extrahepatic bile ducts using near-infrared fluorescent imaging: A technical feasibility study.
- ACRONYMN/A
- hypothesisThe extrahepatic bile ducts may be visualized during cholecystectomy using a near-infrared fluorescence camera and an injection of indocyanine green into the gallbladder.
- Healt Condition(s) or Problem(s) studiedSymptomatic cholecystolithiasis
- Inclusion criteriaPatients between 21 and 65 with cholecystolithiasis and an indication for elective open cholecystectomy.
- Exclusion criteria1. Pregnant women;
2. Renal insufficiency;
3. Hyperthyroidism;
4. History of allergic reactions;
5. ASA III-IV.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 11-jan-2009
- planned closingdate1-feb-2009
- Target number of participants10
- InterventionsInjection with indocyanine green solution into the gallbladder during cholecystectomy after which imaging will take place using a near-infrared fluorescence camera.
- Primary outcomeVisualisation of the gallbladder, cystic duct, and common bile duct.
- Secondary outcomeN/A
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. G.M. Dam, van
- CONTACT for SCIENTIFIC QUERIES K.T. Buddingh
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryThis study aims to investigate whether the extrahepatic bile ducts may intraoperatively be visualised using a near-infrared fluorescence camera system and an injection of indocyanine green into the gallbladder.
- Main changes (audit trail)
- RECORD9-sep-2009 - 4-nov-2009


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