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Trial registered on ANZCTR


Registration number
ACTRN12608000152325
Ethics application status
Approved
Date submitted
27/03/2008
Date registered
31/03/2008
Date last updated
31/03/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Near infrared laser confocal endomicroscopy of the human liver.
Scientific title
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.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Liver disease: fibrosis, cirrhosis, steatosis, inflammation 2958 0
Condition category
Condition code
Inflammatory and Immune System 3098 3098 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 2691 0
Diagnosis / Prognosis
Comparator / control treatment
The standard laparoscopy procedure undergone by all subjects will involve liver biopsy, which will act as the control diagnostic procedure. The liver biopsy will be performed immediately after endomicroscopic imaging to provide conventional histopathological diagnosis of cellular and architecture features and liver disease status.
Control group
Active

Outcomes
Primary outcome [1] 3986 0
Endomicroscopy images from the liver
Timepoint [1] 3986 0
During mini-laparoscopy approximately 30-40 images will be collected from each imaging site to document the surface and subsurface cellular structure of the liver.
Primary outcome [2] 3987 0
Conventional histology from the liver biopsy
Timepoint [2] 3987 0
Histopathological anaylsis of each liver biopsy will be available from pathology approximately 1 week post mini-laparoscopy.
Secondary outcome [1] 6706 0
Accuracy of endomicroscopy for predicting histology based on a simple image classification system
Timepoint [1] 6706 0
Predictions of histology will be made immediately after confocal images of the liver are obtained, and before conventional histology results are known.

Eligibility
Key inclusion criteria
Patients indicated for laparoscopic liver assessment as determined by the attending hepatologist, age >18 years, a negative pregnancy test, written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 824 0
Germany
State/province [1] 824 0

Funding & Sponsors
Funding source category [1] 3215 0
Commercial sector/Industry
Name [1] 3215 0
Optiscan Pty Ltd
Country [1] 3215 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Optiscan Pty Ltd
Address
15-17 Normanby Road
Notting Hill Victoria 3168
Country
Australia
Secondary sponsor category [1] 2882 0
None
Name [1] 2882 0
Address [1] 2882 0
Country [1] 2882 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5200 0
Ethics Committee of Rheinland-Pfalz
Ethics committee address [1] 5200 0
Ethics committee country [1] 5200 0
Germany
Date submitted for ethics approval [1] 5200 0
Approval date [1] 5200 0
22/02/2008
Ethics approval number [1] 5200 0
837.019.06 (5116)

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28462 0
Address 28462 0
Country 28462 0
Phone 28462 0
Fax 28462 0
Email 28462 0
Contact person for public queries
Name 11619 0
Ms Elise Murr
Address 11619 0
15-17 Normanby Road
Notting Hill Victoria 3168
Country 11619 0
Australia
Phone 11619 0
+61 3 95383333
Fax 11619 0
+61 3 95627742
Email 11619 0
[email protected]
Contact person for scientific queries
Name 2547 0
Dr Martin Goetz
Address 2547 0
I. Medizinische Klinik und Poliklinik
Universitätsklinik Mainz
Langenbeckstr 1
D-55131 Mainz
Country 2547 0
Germany
Phone 2547 0
0049 6131171
Fax 2547 0
0049 6131173438
Email 2547 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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