Intraoperative bile duct visualisation in children with biliary atresia using a fluorescence camera system: a pilot study - Bile duct mapping with fluorescence in BA
- Conditions
- Biliary atresia
- Registration Number
- EUCTR2009-014886-21-NL
- Lead Sponsor
- niversity Medical Centre Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 4
Inclusion Criteria
Patients with suspected biliary atresia.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
History of iodine allergy or anaphylactic reactions to insect bites or medication. Presence or history of hyperthyroidism. Severe renal or liver failure.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to confirm the diagnosis of biliary atresia by visualisation of the (remaining) biliary tract using fluorescence cholangiography.;Secondary Objective: None;Primary end point(s): The main endpoint is confirmation of the diagnosis biliary atresia, defined as fluorescent signal in the liver and possibly proximal remaining biliary structures without continuation into the duodenum.
- Secondary Outcome Measures
Name Time Method