The primary objective is to confirm the diagnosis of biliary atresia by visualisation of the (remaining) biliary tract using fluorescence cholangiography.
ID
Source
Brief title
Condition
- Bile duct disorders
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
None.
Background summary
Biliary atresia (BA) is a cholangiopathy starting or progressing soon after
birth that renders the extrahepatic bile ducts obliterated. The disease is
fatal if untreated, and even with treatment the majority of children will need
liver transplantation within several years. The mainstay of treatment for BA is
portoenterostomy: the Kasai procedure. The Kasai procedure consists of
resection of the fibrotic hilar plate followed by anastomosis of a loop of
bowel onto the liver: the porto-enterostomy.The outcome (need for liver
transplantation and survival) is largely dependent on the success of the
surgical procedure, i.e. achieving restoration of bile flow.
Currently the intraoperative cholangiogram is the method of choice to confirm
the presence of BA and to provide the surgeon with information on the anatomy
of the remaining biliary structures. This cholangiogram is the first step in
the operation, and when the diagnosis of biliary atresia is confirmed a Kasai
procedure is performed.
The intraoperative cholangiogram has limitations: it can be accompanied by
leakage of contrast, and thus lead to erroneous conclusions, it is a time and
personnel-consuming procedure and it exposes the young infant (1-3 months) to
hazardous radiation. The injection procedure can be technically challenging
because of the small size of biliary structures.
In recent years fluorescence camera systems have emerged that allow in vivo
imaging of bile ducts using an exogenous fluorophore in combination with a
fluorescence camera system. Fluorescence imaging with intravenously
administered ICG could form an easily applicable and safe alternative to
cholangiography with radiocontrast.
Study objective
The primary objective is to confirm the diagnosis of biliary atresia by
visualisation of the (remaining) biliary tract using fluorescence
cholangiography.
Study design
A phase 0 interventional non-randomized pilot study
Study burden and risks
The burden of the study for participants consists of
- an intravenous injection with ICG
- possibly an injection with ICG into the gallbladder
- prolonged surgery time up to 30 minutes
The main risk associated with intravenous injection of ICG is anaphylactic
reaction, which occurs in less than 1/10000 cases, at higher doses than we will
use in this study. Escape medication will be available in the operating room to
intervene if necessary. The extra risk of infection is negligible: the camera
will be covered with specially designed sterile drapes which have been tested
and approved by the UMCG technical service.
Hanzeplein 1
9700 RB Groningen
Nederland
Hanzeplein 1
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Children < 60 days with suspected biliary atresia
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-014886-21-NL |
| CCMO | NL29334.042.09 |