Liver DiseaseNCT02311348
Comparing Pain in Patients Undergoing Percutaneous Versus Transjugular Techniques of Liver Biopsy
An observational study of Liver Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: In a liver biopsy, a small piece of liver is removed. A percutaneous liver biopsy (PLB) is done through a needle on the right side of your belly. In a transjugular liver biopsy (TLB), the right side of the neck is numbed and a straw-like tube is put in. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Liver Disease
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2014to 21 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Criteria for subject selection will include the following:
- 18 years of age or older
- able to read, write and speak English.
- capable of providing informed consent
- subjects undergoing an elective PLB or TLB.
- baseline pain level will be assessed prior to the liver biopsy using both VAS and NPS.
- an assessment of pain threshold using a medical device called a dolorimeter.
- must be enrolled into the 91-DK-0214 protocol
Who cannot join
- patients who are unable to give consent will be excluded from the study.
- Patient report of a pain level of four or more pre liver biopsy
- The patient must undergo a baseline pain assessment prior to the liver biopsy using the dolorimeter.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Background: In a liver biopsy, a small piece of liver is removed. A percutaneous liver biopsy (PLB) is done through a needle on the right side of your belly. In a transjugular liver biopsy (TLB), the right side of the neck is numbed and a straw-like tube is put in. The tube goes down to your liver and a piece of liver is removed. Researchers want to learn more about the pain people feel after each of these procedures.
Objectives: To compare whether there is more pain associated with the PLB versus TLB.
Read more
Eligibility: Adults 18 years or older enrolled in a separate protocol (91-DK-0214) for liver biopsy. They must be able to read, write, and speak English.
Design: Under the separate protocol (91-DK-0214), participants will be screened and have a liver biopsy.
Before the biopsy, participants will give their medical history. They will answer questions about past surgeries and how they feel about pain.
Participants will have a pain test with a device called a dolorimeter. They will sit up with their feet on the ground, and put their thumbs on a table. They will feel pressure on each thumb until it they say it is painful.
Before the biopsy and 2, 4, and 6 hours after the biopsy, they will answer pain questions.
Read the detailed description
Millions of Americans are diagnosed with some form of Hepatitis or other liver disease requiring treatment. Liver biopsies are frequently performed mainly to stage disease, aid in diagnosis and to guide treatment. As part of the assessment of Hepatitis patients, a liver biopsy is frequently part of the regimen. Liver biopsy procedures can be performed using one of two methods: percutaneous liver biopsy (PLB) or transjugular liver biopsy (TLB). Alknawy \& Shiffman (2007) discuss approaches of percutaneous liver biopsy that included the percussion-palpation approach, image guided, ultrasound assisted, ultrasound guided and type of biopsy needle used. The method of liver biopsy selected will not be randomly assigned but will be determined by the hepatologist caring for the patient. Pain can be a complication following a liver biopsy requiring adequate pain management.
Despite an extensive review of previous studies, none were found that discussed the pain experiences of patients who have undergone PLB versus TLB. This study proposes to compare the amount of pain experienced by patients who have undergone PLB versus TLB. Thirty-two male and female patients age 18 years and older who meet study criteria will be invited to participate. The participants will be placed into either the PLB or TLB group with each group consisting of 16 male or 16 female participants. Prior to the biopsy and within the first 6 hours post procedure, at the 2, 4 and 6-hour time points, the patient will be asked to rate their pain on the Visual Analogue Scale (VAS) and on the Numeric Pain Scale (NPS). Additionally, the dolorimeter will be used pre liver biopsy along with the VAS and the NPS as standardized pain measurements.
- Conditions
- Liver Disease
- Keywords
- Biopsy, Pain
- Medical subject headings
- Liver Diseases, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain comparison between 2 groups
Measured: 0, 2, 4, & 6 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study start20 Nov 2014
- Primary completion21 Dec 2016
- Study completion21 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Vanessa Haynes-Williams, R.N., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311348
- Sponsor's protocol ID
- 150025
- Other IDs
- 15-DK-0025
- Status last verified
- 21 Dec 2016
- First submitted
- 5 Dec 2014
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Pain in Patients Undergoing Percutaneous Versus Transjugular Techniques of Liver Biopsy
- ClinicalTrials.gov ID
- NCT02311348
- Acronym / sponsor ID
- 150025
- Conditions
- Liver Disease
- Keywords
- Biopsy, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 20 Nov 2014
- Primary completion
- 21 Dec 2016 (actual)
- Study completion
- 21 Dec 2016 (actual)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: In a liver biopsy, a small piece of liver is removed. A percutaneous liver biopsy (PLB) is done through a needle on the right side of your belly. In a transjugular liver biopsy (TLB), the right side of the neck is numbed and a straw-like tube is put in. The tube goes down to your liver and a piece of liver is removed. Researchers want to learn more about the pain people feel after each of these procedures.
Objectives: To compare whether there is more pain associated with the PLB versus TLB.
Eligibility: Adults 18 years or older enrolled in a separate protocol (91-DK-0214) for liver biopsy. They must be able to read, write, and speak English.
Design: Under the separate protocol (91-DK-0214), participants will be screened and have a liver biopsy.
Before the biopsy, participants will give their medical history. They will answer questions about past surgeries and how they feel about pain.
Participants will have a pain test with a device called a dolorimeter. They will sit up with their feet on the ground, and put their thumbs on a table. They will feel pressure on each thumb until it they say it is painful.
Before the biopsy and 2, 4, and 6 hours after the biopsy, they will answer pain questions.
Detailed description
Millions of Americans are diagnosed with some form of Hepatitis or other liver disease requiring treatment. Liver biopsies are frequently performed mainly to stage disease, aid in diagnosis and to guide treatment. As part of the assessment of Hepatitis patients, a liver biopsy is frequently part of the regimen. Liver biopsy procedures can be performed using one of two methods: percutaneous liver biopsy (PLB) or transjugular liver biopsy (TLB). Alknawy \& Shiffman (2007) discuss approaches of percutaneous liver biopsy that included the percussion-palpation approach, image guided, ultrasound assisted, ultrasound guided and type of biopsy needle used. The method of liver biopsy selected will not be randomly assigned but will be determined by the hepatologist caring for the patient. Pain can be a complication following a liver biopsy requiring adequate pain management.
Despite an extensive review of previous studies, none were found that discussed the pain experiences of patients who have undergone PLB versus TLB. This study proposes to compare the amount of pain experienced by patients who have undergone PLB versus TLB. Thirty-two male and female patients age 18 years and older who meet study criteria will be invited to participate. The participants will be placed into either the PLB or TLB group with each group consisting of 16 male or 16 female participants. Prior to the biopsy and within the first 6 hours post procedure, at the 2, 4 and 6-hour time points, the patient will be asked to rate their pain on the Visual Analogue Scale (VAS) and on the Numeric Pain Scale (NPS). Additionally, the dolorimeter will be used pre liver biopsy along with the VAS and the NPS as standardized pain measurements.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or older
- able to read, write and speak English.
- capable of providing informed consent
- subjects undergoing an elective PLB or TLB.
- baseline pain level will be assessed prior to the liver biopsy using both VAS and NPS.
Key exclusion criteria (3 listed)
- patients who are unable to give consent will be excluded from the study.
- Patient report of a pain level of four or more pre liver biopsy
- The patient must undergo a baseline pain assessment prior to the liver biopsy using the dolorimeter.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pain comparison between 2 groups
Time frame: 0, 2, 4, & 6 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Haynes-Williams, R.N. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain comparison between 2 groups (time frame: 0, 2, 4, & 6 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.