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Comparing Pain in Patients Undergoing Percutaneous Versus Transjugular Techniques of Liver Biopsy

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
Overall Status
Completed
CT.gov ID
NCT02311348
Collaborator
(none)
32
Enrollment
1
Location
25
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    32 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Comparing Pain in Patients Undergoing Percutaneous Versus Transjugular Techniques of Liver Biopsy
    Study Start Date :
    Nov 20, 2014
    Actual Primary Completion Date :
    Dec 21, 2016
    Actual Study Completion Date :
    Dec 21, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Pain comparison between 2 groups [0, 2, 4, & 6 hour]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • INCLUSION CRITERIA:
    Criteria for subject selection will include the following:

    1. 18 years of age or older

    2. able to read, write and speak English.

    3. capable of providing informed consent

    4. subjects undergoing an elective PLB or TLB.

    5. baseline pain level will be assessed prior to the liver biopsy using both VAS and NPS.

    6. an assessment of pain threshold using a medical device called a dolorimeter.

    7. must be enrolled into the 91-DK-0214 protocol

    EXCLUSION CRITERIA:

    1. patients who are unable to give consent will be excluded from the study.

    2. Patient report of a pain level of four or more pre liver biopsy

    3. The patient must undergo a baseline pain assessment prior to the liver biopsy using the dolorimeter.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland United States 20892

    Sponsors and Collaborators

    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Investigators

    • Principal Investigator: Vanessa Haynes-Williams, R.N., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    ClinicalTrials.gov Identifier:
    NCT02311348
    Other Study ID Numbers:
    • 150025
    • 15-DK-0025
    First Posted:
    Dec 8, 2014
    Last Update Posted:
    Jul 2, 2017
    Last Verified:
    Dec 21, 2016
    Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Biopsy
    Pain
    Additional relevant MeSH terms:
    Liver Diseases

    Study Results

    No Results Posted as of Jul 2, 2017