Near infrared laser confocal endomicroscopy of the human liver.

Patients with known or suspected liver disease who are indicated for laparoscopic liver biopsy undergo near infrared confocal imaging, to assess the feasibility and diagnostic potential of in vivo confocal images compared with conventional histopathological analysis of liver biopsy tissue.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000152325

Enrollment

Registered

2008-03-31

Start date

2008-03-25

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The study aims to evaluate the diagnostic accuracy of a near infrared confocal imaging device for identifying the cellular and architectural features of liver disease during mini-laparoscopy.

Interventions

All patients in the study will undergo standard mini-laparoscopy plus near infrared confocal endomicroscopy. In vivo microscopic imaging using an intravenously administered fluorescent contrast agent (Indocyanine Green 0.5%) is performed by placing the rigid imaging probe in contact with the liver during the participant's routine mini-laparoscopy procedure. Endomicroscopy is expected to add 5-10 minutes to each participant's mini-laparoscopy procedure (1 session per participant).

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients indicated for laparoscopic liver assessment as determined by the attending hepatologist, age >18 years, a negative pregnancy test, written informed consent.

Exclusion criteria

Patients under the age of 18 years. Patients with blood coagulation disorders (Quick's test <50%; PTT>50s; platelets <50.000/nl), impaired renal function (serum creatinine >1.2mg/dl), lack of liver visualisation by ultrasonography, uncontrolled ascites or hyperthyreosis. Patients unable to give informed consent. Women who are pregnant or breast-feeding. Patients with known allergy or prior adverse reaction to Indocyanine Green.

Outcome results