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Trial registered on ANZCTR


Registration number
ACTRN12610000110088
Ethics application status
Not yet submitted
Date submitted
29/01/2010
Date registered
2/02/2010
Date last updated
2/02/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Ultrasound-guided non-targeted liver biopsies: complication rates of single versus multiple pass techniques
Scientific title
Ultrasound-guided non-targeted liver biopsies: complication rates of single versus multiple pass techniques in patients requiring non-targeted liver biopsies.
Secondary ID [1] 1356 0
None
Universal Trial Number (UTN)
U1111-1113-5264
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
All patient's requiring ultrasound-guided non-targeted liver biopsies. 256716 0
Condition category
Condition code
Oral and Gastrointestinal 256873 256873 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An ultrasound-guided liver biopsy is the removal of a sample of tissue from the liver that is then sent to pathology for testing.

Liver biopsies performed in medical imaging are done with guidance from an ultrasound machine to ensure that the sampling needle is taking a sample from the correct part of the liver and that it is away from major blood vessels, lung, and other areas that are not meant to be sampled.

Patients normally get one or two samples depending on how easy the sample can be obtained, how much tissue is removed each sample, and a variety of other reasons determined by the radiologist doing the biopsy.

The biopsy itself only takes 10-15 minutes. Preparation of the equipment, explanation, introduction to staff, getting changed, and moving in and out of the room means the event takes approximately 45 minutes. Patients are observed for 2 hours after the procedure.
Intervention code [1] 255944 0
Diagnosis / Prognosis
Comparator / control treatment
The purpose of a liver biopsy is to get a sample of liver tissue. This tissue sample is then sent to pathology and looked at under a microscope to determine the diagnosis. The biopsy may require one or two samples to get sufficient tissue to make a diagnosis. The more tissue sampled, the easier it is to make a diagnosis but the more side effects the patient may have.

Therefore we would like to compare two groups. One group will have an ultrasound-guided non-targeted liver biopsy (using a 14 gauge needle) to obtain ONE sample of tissue, the other group will have an ultrasound-guided non-targeted liver biopsy (using a 14 gauge needle) to obtain TWO samples of tissue.
Control group
Active

Outcomes
Primary outcome [1] 257742 0
Acquisition of a liver biopsy sample
Timepoint [1] 257742 0
Completion of the biopsy
Secondary outcome [1] 263109 0
The most common side effects of ultrasound-guided liver biopsies are pain and bleeding.

Nurses take frequent observations before, during, and after the procedure to monitor for signs of pain, bleeding, and other complications. These observations include pain using a numerical pain scale, bleeding at the site, bleeding in the liver (radiologist observes ultrasound images whilst performing the biopsy to look for signs of bleeding), and blood pressure, temperature, heart rate, respiratory rate, and oxygen saturations using a pulse oximeter and automated observation equipment.

This continues at regular intervals until 2 hours after the procedure. There is also a follow-up phone call the next day to ensure the patient is comfortable.
Timepoint [1] 263109 0
Pain levels will be recorded before the procedure, the patient will have the biospy and any adverse events are recorded by the radiologist. The patient will remain in the nursing recovery area and pain, bleeding, side effects will be monitored for 2 hours. There will be a phone call for follow-up within 24 hours. This is the normal routine for liver biopsy patients.

Eligibility
Key inclusion criteria
All patients presenting to the Royal Brisbane & Women's Hospital (RBWH) Department of Medical Imaging (DMI) who need ultrasound-guided, non-targeted liver biopsies. The study group will not include children as it is an adult hospital. The groups will be randomised to include equal numbers of men and women.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All patients will be getting biopsies based on a clinical indication. They will have various medical comorbidities. It is an "all-comers" trial to ensure the results are clinically relevant. Patients won't be included/excluded on their physical fitness. They will simply be included if they need a non-targeted liver biopsy for any reason. Patients with International Normalised Ratio (INR) over 1.5 may be excluded for safety as they are at increased risk of bleeding (current practice). This will be at the discretion of the interventional radiologist performing the biopsy.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients presenting for ultrasound-guided, non-targeted liver biopsies will be asked to participate in the trial by the radiologist performing the biopsy. All patients requiring liver biopsies will be included in the trial.

Patients willing to participate will be randomly assigned to one of two sample groups as they present.

A random allocation spreadsheet has been produced by the statisticians to ensure there will be equal numbers of men and women. One group will have a single biopsy sample, the second group will have two biopsy samples. Allocation is not concealed.

Due to the nature of the trial, the patients cannot be blinded during the procedure as they will know how many samples are being taken. Patients will not be made aware of which group they are participating to prevent biasing pain perception.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation table will be used according to advice from our biostatisticians.

The protocol will be:
- a patient arrives
- determine if they are male or female
- if male go to the next available number on the male list, assign the
patient to that group and then tick the number off the list (to ensure
that it is not reused).
- if female, do the equivalent on the female list
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
296
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256439 0
Hospital
Name [1] 256439 0
Department of Medical Imaging
Country [1] 256439 0
Australia
Primary sponsor type
Individual
Name
Dr Luke A Danaher
Address
Senior House Officer Medical Imaging Research
Level 3 Ned Hanlon Building
Royal Brisbane & Women's Hospital
Cnr Butterfield St & Bowen Bridge Road
HERSTON QLD 4029
Country
Australia
Secondary sponsor category [1] 255740 0
Individual
Name [1] 255740 0
Dr Aidan Callinan
Address [1] 255740 0
Consultant Radiologist
Level 3 Ned Hanlon Building
Royal Brisbane & Women's Hospital
Cnr Butterfield St & Bowen Bridge Road
HERSTON QLD 4029
Country [1] 255740 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258495 0
Royal Brisbane & Women's Hospital (RBWH) Human Research Ethics Committee (HREC)
Ethics committee address [1] 258495 0
Level 7 Block 7
Royal Brisbane & Women's Hospital
Cnr Butterfield St & Bowen Bridge Road
HERSTON QLD 4029
Ethics committee country [1] 258495 0
Australia
Date submitted for ethics approval [1] 258495 0
23/02/2010
Approval date [1] 258495 0
Ethics approval number [1] 258495 0
EC00172

Summary
Brief summary
Liver biopsy procedures are conducted using either a ‘single pass’ or ‘multiple pass’ method whereby a needle is inserted into the patient to extract liver material once (single pass) or more than once (multiple pass). The type of procedure used depends on the practitioner’s preference as there is a need to strike a balance between ensuring extraction of a sufficient tissue sample and the comfort / safety of the patient.

The aim of this project will be to compare the complication rate of single versus multiple pass techniques in ultrasound-guided non-targeted liver biopsies.

It will be a randomised, prospective trial in which patients will enter one of two groups. The first group of patients will have a single 14gauge(g) non-targeted ultrasound-guided liver biopsy. The second group will have two 14g non-targeted ultrasound-guided liver biopsies using a foam plug for haemostasis. Due to the interventional nature of liver biopsies, the clinicians and patients are unable to be blinded. All patients will continue to have an International Normalised Ratio (INR) prior to their procedure (current practice). Consent for the procedure will be obtained along with consent to participate in the trial. Patients will be assessed for pain in the recovery period using a visual pain scale and clinicians will be required to document peri/procedural complications. The reporting pathologist will be required to comment on the diagnostic yield and quality of the biopsy sample. These additional data collection steps will be included in an addendum to current liver biopsy clinical pathway.

The rationale for comparing these two groups is to reflect clinical practice as these two techniques are used by different interventional radiologists at RBWH and to establish whether one technique should be adopted universally within the department.

The results will review safety, patient tolerability, yield, clinical indication, and coagulation status with an emphasis on complications including pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30790 0
Address 30790 0
Country 30790 0
Phone 30790 0
Fax 30790 0
Email 30790 0
Contact person for public queries
Name 14037 0
Dr Luke A Danaher
Address 14037 0
Department of Medical Imaging Research
Level 3 Ned Hanlon Building
Royal Brisbane & Women's Hospital
Cnr Butterfield St & Bowen Bridge Road
HERSTON QLD 4029
Country 14037 0
Australia
Phone 14037 0
+61 7 3636 7225
Fax 14037 0
+61 7 3636 0862
Email 14037 0
[email protected]
Contact person for scientific queries
Name 4965 0
Dr Luke A Danaher
Address 4965 0
Department of Medical Imaging Research
Level 3 Ned Hanlon Building
Royal Brisbane & Women's Hospital
Cnr Butterfield St & Bowen Bridge Road
HERSTON QLD 4029
Country 4965 0
Australia
Phone 4965 0
+61 7 3636 7225
Fax 4965 0
+61 7 3636 0862
Email 4965 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

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