Intraoperative bile duct visualisation in children with biliary atresia using a fluorescence camera system: a pilot study - Bile duct mapping with fluorescence in BA

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014886-21-NL

Enrollment

Registered

2009-09-21

Start date

2010-01-26

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary atresia

Interventions

Trade Name: ICG-Pulsion 25mg Product Name: ICG Pulsion Product Code: VO4CX Pharmaceutical Form: Emulsion for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: History of iodine allergy or anaphylactic reactions to insect bites or medication. Presence or history of hyperthyroidism. Severe renal or liver failure.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026