None listed
Conditions
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.
Interventions
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
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.
Sponsors
Dr Luke A Danaher
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed