<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03307811</url>
  </required_header>
  <id_info>
    <org_study_id>1055744</org_study_id>
    <nct_id>NCT03307811</nct_id>
  </id_info>
  <brief_title>Endoscopic Ultrasound Guided Liver Biopsy</brief_title>
  <official_title>Endoscopic Ultrasound Guided Liver Biopsy Using a 22 Gauge Fine Needle Biopsy Needle.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AdventHealth</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AdventHealth</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective study to determine the optimal technique for obtaining liver tissue&#xD;
      with a smaller caliber (22 gauge) needle and whether a good core biopsy can be obtained&#xD;
      without the use of suction and secondly to determine the diagnostic yield and safety of 22 g&#xD;
      Fine Needle Biopsy needle for liver biopsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Liver biopsy (LB) has historically been performed by percutaneous route without image&#xD;
      guidance (blind biopsy). However, in the last several years there has been more reliance on&#xD;
      image guidance ultrasound-guided (USG) or computed tomography (CT) to direct the needle into&#xD;
      the liver with the hope of limiting complications. Other ways of performing liver biopsy are&#xD;
      transjugular fluoroscopy guided approach when percutaneous route is deemed not safe because&#xD;
      of coagulopathy or ascites. Surgical LB (either laparoscopic or open) is yet another way of&#xD;
      obtaining liver tissue.&#xD;
&#xD;
      Endoscopic ultrasound guided liver biopsy (EUS-LB) is proposed as a newer method that may&#xD;
      offer several potential advantages over existing techniques for attaining liver tissue. It&#xD;
      can be performed in an outpatient setting and offers the comfort of sedation and analgesia.&#xD;
      Endoscopic Ultrasound (EUS) provides high resolution images of left lobe of the liver and a&#xD;
      good portion of the right lobe of the liver. This coupled with Doppler capability the biopsy&#xD;
      needle can be safely directed into the liver for sampling under real time image guidance.&#xD;
      Intervening structures such as pleura, bowel loops and gallbladder can be easily seen by EUS&#xD;
      and thus avoided that further decreases the risk of adverse events. It has been recognized&#xD;
      that sampling error can lead to diagnostic inaccuracy of a biopsy from a single site. As&#xD;
      compared to USG or CT scan the EUS allows easy and safe biopsy of both left and right lobes&#xD;
      of the liver during same setting, potentially addressing concerns about sampling error.&#xD;
&#xD;
      The cost of the endoscopic procedure is the main expense of EUS-LB. Thus this approach is&#xD;
      best used for patients requiring EUS for evaluation of elevated liver tests. If no&#xD;
      obstructive lesion is identified by EUS that will require endoscopic retrograde&#xD;
      cholangiopancreatography (ERCP) then it would cost-effective to perform EUS-LB during the&#xD;
      same setting without much additional time and risks. This approach can spare the patient the&#xD;
      additional discomfort and expense of a second dedicated LB procedure by any of the other&#xD;
      available techniques (percutaneous, transjugular etc.). In such setting the equipment costs&#xD;
      for the EUS-LB will mainly include only the Fine Needle Biopsy (FNB) needle, which is similar&#xD;
      in expense to the cost of needles for the transjugular or percutaneous approach.&#xD;
&#xD;
      The traditionally used transcutaneous LB needle is 16 gauge (G) while largest EUS biopsy&#xD;
      needle is 19 G. The smaller size of the needle is expected to decrease the complications rate&#xD;
      (mainly pain and bleeding) even further. Many studies using a 19 G Tru-cut biopsy or Fine&#xD;
      Needle Aspiration (FNA) needle to acquire liver tissue have obtained specimens adequate for&#xD;
      histologic diagnosis but there has been a wide range of specimen adequacy (19-100%). The 19 G&#xD;
      Tru-cut biopsy needle has been associated with several technical difficulties that could&#xD;
      reflect negatively on tissue adequacy.&#xD;
&#xD;
      While it is easy and straight forward to biopsy the left lobe of the liver with any EUS&#xD;
      needle. The 19 G needle is a large bore needle for EUS use and it is sometimes difficult to&#xD;
      attain an adequate position for biopsy specially in duodenum where scope is torqued and this&#xD;
      is the only area of access to right lobe.&#xD;
&#xD;
      In this study the investigators will use a 22 G needle. Smaller caliber of the needle would&#xD;
      not only make it technically easier to access right lobe of the liver through the duodenum,&#xD;
      it is also expected to decrease the risks further due to smaller size. Also, the 22 G EUS-FNB&#xD;
      needle has three cutting points at the cutting edge of the needle that provide stability at&#xD;
      puncture while the high quality, fully formed heels are designed to maximize tissue capture&#xD;
      and minimize fragmentation, that would result in attaining a good histological specimen, a&#xD;
      main stay for liver biopsy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">October 1, 2018</completion_date>
  <primary_completion_date type="Actual">June 19, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic adequacy of the liver biopsy specimen</measure>
    <time_frame>Sample obtained during EUS-guided liver biopsy.</time_frame>
    <description>Determine the diagnostic adequacy of the liver biopsy specimen by obtaining a histological specimen using a smaller (22 G) caliber needle. Diagnostic adequacy is defined as a sample that provides definitive pathological diagnosis (yes, no).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visible core</measure>
    <time_frame>Sample obtained during EUS-guided liver biopsy.</time_frame>
    <description>The sample will have a visible core (yes/no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suction</measure>
    <time_frame>Sample obtained during EUS-guided liver biopsy.</time_frame>
    <description>Sample was obtained using suction (yes/no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of passes required histological samples</measure>
    <time_frame>Time of Liver biopsy</time_frame>
    <description>Assessing the median number of passes required to obtain diagnostically adequate histological samples histological samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical failure</measure>
    <time_frame>Time of Liver biopsy</time_frame>
    <description>Was there a technical failure (yes/no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications/Bleeding</measure>
    <time_frame>1 month</time_frame>
    <description>Assessing subjects for post-procedural complications via follow up phone calls. Bleeding (yes/no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications/Pain</measure>
    <time_frame>1 month</time_frame>
    <description>Assessing subjects for post-procedural complications via follow up phone calls. Pain (yes/no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications/Infection</measure>
    <time_frame>1 Month</time_frame>
    <description>Assessing subjects for post-procedural complications via follow up phone calls. Infection (yes/no).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Hepatic Cancer</condition>
  <condition>Hepatic Neoplasm</condition>
  <condition>Hepatic Carcinoma</condition>
  <arm_group>
    <arm_group_label>22 gauge needle liver biopsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EUS-LB will be performed using a 22 g FNB needle. Specimens obtained from each pass will be placed in a separate biopsy jar. If the third pass does not result in sufficient diagnostic material, a 19 G will be used. A maximum of 3 passes will be made using the alternate needle. The total number of passes with the 22 G needle and the 19 G needle is 6. Data will be collected about the procedure and the performance of the needles for each procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>22 gauge needle liver biopsy</intervention_name>
    <description>EUS will be performed. Specimens obtained from each pass will be placed in a separate biopsy jar. If the third pass does not result in sufficient diagnostic material, a 19 G will be used. A maximum of 3 passes will be made using the alternate needle. The total number of passes with the 22 G needle and the 19 G needle is 6. Data will be collected about the procedure and the performance of the needles for each procedure.</description>
    <arm_group_label>22 gauge needle liver biopsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. All patients referred to Florida Hospital Endoscopy Unit for assessment of elevated&#xD;
             liver tests with EUS and are found to have no obstructive lesion to explain elevation&#xD;
             of liver tests and will not require ERCP.&#xD;
&#xD;
          2. Age ≥ 19 years&#xD;
&#xD;
          3. Willing to provide informed consent verbal or written.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &lt;19 years&#xD;
&#xD;
          2. Unable to safely undergo EUS for any reason&#xD;
&#xD;
          3. Coagulopathy (INR &gt;1.6, Thrombocytopenia with platelet count &lt;50,000/ml) for subjects&#xD;
             on anti-coagulation therapy.&#xD;
&#xD;
          4. Unwilling or cognitively unable to provide informed consent verbal or written.&#xD;
&#xD;
          5. Pregnancy (confirmed with Standard of Care urine pregnancy test for all women with&#xD;
             child-bearing potential only)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Muhammad Hasan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Florida Hospital - Center for Interventional Endoscopy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Interventional Endoscopy - Florida Hospital</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Rockey DC, Caldwell SH, Goodman ZD, Nelson RC, Smith AD; American Association for the Study of Liver Diseases. Liver biopsy. Hepatology. 2009 Mar;49(3):1017-44. doi: 10.1002/hep.22742. No abstract available.</citation>
    <PMID>19243014</PMID>
  </reference>
  <reference>
    <citation>Kalambokis G, Manousou P, Vibhakorn S, Marelli L, Cholongitas E, Senzolo M, Patch D, Burroughs AK. Transjugular liver biopsy--indications, adequacy, quality of specimens, and complications--a systematic review. J Hepatol. 2007 Aug;47(2):284-94. doi: 10.1016/j.jhep.2007.05.001. Epub 2007 May 24.</citation>
    <PMID>17561303</PMID>
  </reference>
  <reference>
    <citation>Mathew A. EUS-guided routine liver biopsy in selected patients. Am J Gastroenterol. 2007 Oct;102(10):2354-5. doi: 10.1111/j.1572-0241.2007.01353_7.x. No abstract available.</citation>
    <PMID>17897349</PMID>
  </reference>
  <reference>
    <citation>Gleeson FC, Clayton AC, Zhang L, Clain JE, Gores GJ, Rajan E, Smyrk TC, Topazian MD, Wang KK, Wiersema MJ, Levy MJ. Adequacy of endoscopic ultrasound core needle biopsy specimen of nonmalignant hepatic parenchymal disease. Clin Gastroenterol Hepatol. 2008 Dec;6(12):1437-40. doi: 10.1016/j.cgh.2008.07.015. Epub 2008 Jul 26.</citation>
    <PMID>19081532</PMID>
  </reference>
  <reference>
    <citation>Dewitt J, McGreevy K, Cummings O, Sherman S, Leblanc JK, McHenry L, Al-Haddad M, Chalasani N. Initial experience with EUS-guided Tru-cut biopsy of benign liver disease. Gastrointest Endosc. 2009 Mar;69(3 Pt 1):535-42. doi: 10.1016/j.gie.2008.09.056.</citation>
    <PMID>19231495</PMID>
  </reference>
  <reference>
    <citation>Stavropoulos SN, Im GY, Jlayer Z, Harris MD, Pitea TC, Turi GK, Malet PF, Friedel DM, Grendell JH. High yield of same-session EUS-guided liver biopsy by 19-gauge FNA needle in patients undergoing EUS to exclude biliary obstruction. Gastrointest Endosc. 2012 Feb;75(2):310-8. doi: 10.1016/j.gie.2011.09.043.</citation>
    <PMID>22248599</PMID>
  </reference>
  <reference>
    <citation>Nakai Y, Samarasena JB, Iwashita T, Park DH, Lee JG, Hu KQ, Chang KJ. Autoimmune hepatitis diagnosed by endoscopic ultrasound-guided liver biopsy using a new 19-gauge histology needle. Endoscopy. 2012;44 Suppl 2 UCTN:E67-8. doi: 10.1055/s-0031-1291567. Epub 2012 Mar 6. No abstract available.</citation>
    <PMID>22396285</PMID>
  </reference>
  <reference>
    <citation>Maharaj B, Maharaj RJ, Leary WP, Cooppan RM, Naran AD, Pirie D, Pudifin DJ. Sampling variability and its influence on the diagnostic yield of percutaneous needle biopsy of the liver. Lancet. 1986 Mar 8;1(8480):523-5. doi: 10.1016/s0140-6736(86)90883-4.</citation>
    <PMID>2869260</PMID>
  </reference>
  <reference>
    <citation>Diehl DL, Johal AS, Khara HS, Stavropoulos SN, Al-Haddad M, Ramesh J, Varadarajulu S, Aslanian H, Gordon SR, Shieh FK, Pineda-Bonilla JJ, Dunkelberger T, Gondim DD, Chen EZ. Endoscopic ultrasound-guided liver biopsy: a multicenter experience. Endosc Int Open. 2015 Jun;3(3):E210-5. doi: 10.1055/s-0034-1391412. Epub 2015 Feb 27.</citation>
    <PMID>26171433</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>July 17, 2017</study_first_submitted>
  <study_first_submitted_qc>October 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>liver</keyword>
  <keyword>biopsy</keyword>
  <keyword>hepatic</keyword>
  <keyword>EUS</keyword>
  <keyword>fine needle biopsy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Hepatocellular</mesh_term>
    <mesh_term>Liver Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to share the individual participant data with other researchers.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03307811
org study id: 1055744
nct id: NCT03307811
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a prospective study to determine the optimal technique for obtaining liver tissue
      with a smaller caliber (22 gauge) needle and whether a good core biopsy can be obtained
      without the use of suction and secondly to determine the diagnostic yield and safety of 22 g
      Fine Needle Biopsy needle for liver biopsy.
Liver biopsy (LB) has historically been performed by percutaneous route without image
      guidance (blind biopsy). However, in the last several years there has been more reliance on
      image guidance ultrasound-guided (USG) or computed tomography (CT) to direct the needle into
      the liver with the hope of limiting complications. Other ways of performing liver biopsy are
      transjugular fluoroscopy guided approach when percutaneous route is deemed not safe because
      of coagulopathy or ascites. Surgical LB (either laparoscopic or open) is yet another way of
      obtaining liver tissue.

      Endoscopic ultrasound guided liver biopsy (EUS-LB) is proposed as a newer method that may
      offer several potential advantages over existing techniques for attaining liver tissue. It
      can be performed in an outpatient setting and offers the comfort of sedation and analgesia.
      Endoscopic Ultrasound (EUS) provides high resolution images of left lobe of the liver and a
      good portion of the right lobe of the liver. This coupled with Doppler capability the biopsy
      needle can be safely directed into the liver for sampling under real time image guidance.
      Intervening structures such as pleura, bowel loops and gallbladder can be easily seen by EUS
      and thus avoided that further decreases the risk of adverse events. It has been recognized
      that sampling error can lead to diagnostic inaccuracy of a biopsy from a single site. As
      compared to USG or CT scan the EUS allows easy and safe biopsy of both left and right lobes
      of the liver during same setting, potentially addressing concerns about sampling error.

      The cost of the endoscopic procedure is the main expense of EUS-LB. Thus this approach is
      best used for patients requiring EUS for evaluation of elevated liver tests. If no
      obstructive lesion is identified by EUS that will require endoscopic retrograde
      cholangiopancreatography (ERCP) then it would cost-effective to perform EUS-LB during the
      same setting without much additional time and risks. This approach can spare the patient the
      additional discomfort and expense of a second dedicated LB procedure by any of the other
      available techniques (percutaneous, transjugular etc.). In such setting the equipment costs
      for the EUS-LB will mainly include only the Fine Needle Biopsy (FNB) needle, which is similar
      in expense to the cost of needles for the transjugular or percutaneous approach.

      The traditionally used transcutaneous LB needle is 16 gauge (G) while largest EUS biopsy
      needle is 19 G. The smaller size of the needle is expected to decrease the complications rate
      (mainly pain and bleeding) even further. Many studies using a 19 G Tru-cut biopsy or Fine
      Needle Aspiration (FNA) needle to acquire liver tissue have obtained specimens adequate for
      histologic diagnosis but there has been a wide range of specimen adequacy (19-100%). The 19 G
      Tru-cut biopsy needle has been associated with several technical difficulties that could
      reflect negatively on tissue adequacy.

      While it is easy and straight forward to biopsy the left lobe of the liver with any EUS
      needle. The 19 G needle is a large bore needle for EUS use and it is sometimes difficult to
      attain an adequate position for biopsy specially in duodenum where scope is torqued and this
      is the only area of access to right lobe.

      In this study the investigators will use a 22 G needle. Smaller caliber of the needle would
      not only make it technically easier to access right lobe of the liver through the duodenum,
      it is also expected to decrease the risks further due to smaller size. Also, the 22 G EUS-FNB
      needle has three cutting points at the cutting edge of the needle that provide stability at
      puncture while the high quality, fully formed heels are designed to maximize tissue capture
      and minimize fragmentation, that would result in attaining a good histological specimen, a
      main stay for liver biopsy.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnostic adequacy of the liver biopsy specimen
time frame: Sample obtained during EUS-guided liver biopsy.
description: Determine the diagnostic adequacy of the liver biopsy specimen by obtaining a histological specimen using a smaller (22 G) caliber needle. Diagnostic adequacy is defined as a sample that provides definitive pathological diagnosis (yes, no).
measure: Visible core
time frame: Sample obtained during EUS-guided liver biopsy.
description: The sample will have a visible core (yes/no).
measure: Suction
time frame: Sample obtained during EUS-guided liver biopsy.
description: Sample was obtained using suction (yes/no).
measure: Number of passes required histological samples
time frame: Time of Liver biopsy
description: Assessing the median number of passes required to obtain diagnostically adequate histological samples histological samples
measure: Technical failure
time frame: Time of Liver biopsy
description: Was there a technical failure (yes/no).
measure: Complications/Bleeding
time frame: 1 month
description: Assessing subjects for post-procedural complications via follow up phone calls. Bleeding (yes/no).
measure: Complications/Pain
time frame: 1 month
description: Assessing subjects for post-procedural complications via follow up phone calls. Pain (yes/no).
measure: Complications/Infection
time frame: 1 Month
description: Assessing subjects for post-procedural complications via follow up phone calls. Infection (yes/no).
arm group label: 22 gauge needle liver biopsy
arm group type: Experimental
description: EUS-LB will be performed using a 22 g FNB needle. Specimens obtained from each pass will be placed in a separate biopsy jar. If the third pass does not result in sufficient diagnostic material, a 19 G will be used. A maximum of 3 passes will be made using the alternate needle. The total number of passes with the 22 G needle and the 19 G needle is 6. Data will be collected about the procedure and the performance of the needles for each procedure.
intervention type: Other
intervention name: 22 gauge needle liver biopsy
description: EUS will be performed. Specimens obtained from each pass will be placed in a separate biopsy jar. If the third pass does not result in sufficient diagnostic material, a 19 G will be used. A maximum of 3 passes will be made using the alternate needle. The total number of passes with the 22 G needle and the 19 G needle is 6. Data will be collected about the procedure and the performance of the needles for each procedure.
arm group label: 22 gauge needle liver biopsy
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Muhammad Hasan, MD
role: Principal Investigator
affiliation: Florida Hospital - Center for Interventional Endoscopy
facility: 
country: United States
citation: Rockey DC, Caldwell SH, Goodman ZD, Nelson RC, Smith AD; American Association for the Study of Liver Diseases. Liver biopsy. Hepatology. 2009 Mar;49(3):1017-44. doi: 10.1002/hep.22742. No abstract available.
PMID: 19243014
citation: Kalambokis G, Manousou P, Vibhakorn S, Marelli L, Cholongitas E, Senzolo M, Patch D, Burroughs AK. Transjugular liver biopsy--indications, adequacy, quality of specimens, and complications--a systematic review. J Hepatol. 2007 Aug;47(2):284-94. doi: 10.1016/j.jhep.2007.05.001. Epub 2007 May 24.
PMID: 17561303
citation: Mathew A. EUS-guided routine liver biopsy in selected patients. Am J Gastroenterol. 2007 Oct;102(10):2354-5. doi: 10.1111/j.1572-0241.2007.01353_7.x. No abstract available.
PMID: 17897349
citation: Gleeson FC, Clayton AC, Zhang L, Clain JE, Gores GJ, Rajan E, Smyrk TC, Topazian MD, Wang KK, Wiersema MJ, Levy MJ. Adequacy of endoscopic ultrasound core needle biopsy specimen of nonmalignant hepatic parenchymal disease. Clin Gastroenterol Hepatol. 2008 Dec;6(12):1437-40. doi: 10.1016/j.cgh.2008.07.015. Epub 2008 Jul 26.
PMID: 19081532
citation: Dewitt J, McGreevy K, Cummings O, Sherman S, Leblanc JK, McHenry L, Al-Haddad M, Chalasani N. Initial experience with EUS-guided Tru-cut biopsy of benign liver disease. Gastrointest Endosc. 2009 Mar;69(3 Pt 1):535-42. doi: 10.1016/j.gie.2008.09.056.
PMID: 19231495
citation: Stavropoulos SN, Im GY, Jlayer Z, Harris MD, Pitea TC, Turi GK, Malet PF, Friedel DM, Grendell JH. High yield of same-session EUS-guided liver biopsy by 19-gauge FNA needle in patients undergoing EUS to exclude biliary obstruction. Gastrointest Endosc. 2012 Feb;75(2):310-8. doi: 10.1016/j.gie.2011.09.043.
PMID: 22248599
citation: Nakai Y, Samarasena JB, Iwashita T, Park DH, Lee JG, Hu KQ, Chang KJ. Autoimmune hepatitis diagnosed by endoscopic ultrasound-guided liver biopsy using a new 19-gauge histology needle. Endoscopy. 2012;44 Suppl 2 UCTN:E67-8. doi: 10.1055/s-0031-1291567. Epub 2012 Mar 6. No abstract available.
PMID: 22396285
citation: Maharaj B, Maharaj RJ, Leary WP, Cooppan RM, Naran AD, Pirie D, Pudifin DJ. Sampling variability and its influence on the diagnostic yield of percutaneous needle biopsy of the liver. Lancet. 1986 Mar 8;1(8480):523-5. doi: 10.1016/s0140-6736(86)90883-4.
PMID: 2869260
citation: Diehl DL, Johal AS, Khara HS, Stavropoulos SN, Al-Haddad M, Ramesh J, Varadarajulu S, Aslanian H, Gordon SR, Shieh FK, Pineda-Bonilla JJ, Dunkelberger T, Gondim DD, Chen EZ. Endoscopic ultrasound-guided liver biopsy: a multicenter experience. Endosc Int Open. 2015 Jun;3(3):E210-5. doi: 10.1055/s-0034-1391412. Epub 2015 Feb 27.
PMID: 26171433
responsible party type: Sponsor
mesh term: Carcinoma, Hepatocellular
mesh term: Liver Neoplasms
sharing ipd: No
ipd description: There is no plan to share the individual participant data with other researchers.