4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Endoscopic Ultrasound vs Percutaneous Route for Liver Biopsy

Endoscopic Ultrasound vs Percutaneous Route for Liver Biopsy

Study Description
Brief Summary:
This study is to evaluate and directly compare the technical success, tissue quality, diagnostic efficacy and safety profile of Percutaneous and Endoscopic Ultrasound-guided Liver Biopsy.

Condition or disease Intervention/treatment Phase
Liver Biopsy Diagnostic Test: biopsy Not Applicable

Detailed Description:
Liver biopsy (LB) is essential for the diagnosis and evaluation of a variety of hepatic conditions, such as grading/staging of chronic liver disease secondary to alcohol, non-alcoholic steatohepatitis, viral hepatitis, hemochromatosis, Wilson's disease, cholestatic liver disease, as well as in elucidating the etiology of elevation in liver tests.1 Since it was first performed in 1883, percutaneous (PC) liver biopsy has become routine practice and is usually performed under the guidance of real-time imaging using transabdominal ultrasound (US) or computed tomography (CT).1,2 However, in recent times, liver biopsy has been increasingly performed via transgastric or transduodenal routes under endoscopic ultrasound (EUS) guidance. The perceived advantages of performing EUS-LB compared to PC-LB are the ability to simultaneously assess other organs such as common bile duct and pancreas, access to both left and right lobes of the liver and the routine use of conscious sedation during EUS procedures.3 Although single arm cohort studies and retrospective comparative studies assessing the technical success, tissue quality and safety of these different liver biopsy modalities exist, currently there are no randomized trials comparing PC and EUS-guided LB.4-7
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized trial comparing two methods for procuring liver biopsy: 1) EUS-guided and 2) percutaneous.
Masking: Single (Care Provider)
Masking Description: The pathologist will be blinded to the procedure received by the patient.
Primary Purpose: Diagnostic
Official Title: Randomized Trial Comparing Endoscopic Ultrasound-guided Liver Biopsy vs. Percutaneous Liver Biopsy
Actual Study Start Date : July 25, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : May 2021
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Percutaneous Biopsy

The subject would undergo the standard of care procedure for a percutaneous biopsy of the liver.

All percutaneous biopsies will be performed after administration of local anesthetic. No pre-procedure antibiotics will be administered. Subcostal or subxyphoid area will be cleaned and draped in the standard manner. 2% lidocaine solution will be injected subcutaneously using a 25-gauge needle and then administered into the subcutaneous tissue up to the liver capsule. A 16-gauge biopsy needle is inserted into the liver parenchyma under US or CT-guidance, with the location of needle placement left to the discretion of the performing radiologist. One or two core biopsy samples will be obtained. All procured specimens will be placed in a single specimen container of 10% formalin for tissue processing. When biopsy samples have been obtained, the patient will be taken to the recovery area for post-procedure monitoring.

 Diagnostic Test: biopsy
Liver biopsy (LB) is essential for the diagnosis and evaluation of a variety of hepatic conditions, such as grading/staging of chronic liver disease secondary to alcohol, non-alcoholic steatohepatitis, viral hepatitis, hemochromatosis, Wilson's disease, cholestatic liver disease, as well as in elucidating the etiology of elevation in liver tests.
Active Comparator: Endoscopic-guided Ultrasound Biopsy

The subject would undergo the standard of care procedure for an endoscopic-guided biopsy of the liver.

The left lobe of the liver is identified from the gastric lumen, EUS-guided fine needle biopsy (FNB) will be performed using a 19-gauge FNB needle, with the choice of needle type at the discretion of the performing endoscopist. Stylet will only be used to puncture the liver at the time of the first pass and then subsequently removed. No suction will be used. Fanning technique will not be used. A total of 10 to-and-fro needle movements will be performed during each pass. A total of two passes will be performed.All tissue specimens procured will be placed in a single specimen container of 10% formalin for tissue processing. When two passes are complete under EUS-guidance, the echoendoscope will be withdrawn from the patient and the patient will be taken to the recovery area for post-procedure monitoring.

 Diagnostic Test: biopsy
Liver biopsy (LB) is essential for the diagnosis and evaluation of a variety of hepatic conditions, such as grading/staging of chronic liver disease secondary to alcohol, non-alcoholic steatohepatitis, viral hepatitis, hemochromatosis, Wilson's disease, cholestatic liver disease, as well as in elucidating the etiology of elevation in liver tests.
Outcome Measures
Primary Outcome Measures :
  1. Diagnostic adequacy of the tissue sample [ Time Frame: 24 hours ]
    The primary outcome of the randomized trial is to compare between EUS-LB and PC-LB, the rate of procurement of diagnostically adequate specimens, defined as the presence of both maximum specimen length ≥ 25mm AND total no. of complete portal tracts ≥ 11.


Secondary Outcome Measures :
  1. Specimen length [ Time Frame: 24 hours ]
    Maximum specimen length in millimeters after formalin fixation will be documented.

  2. Portal tracts [ Time Frame: 24 hours ]
    The total number of complete portal tracts for each biopsy specimen will be documented.

  3. Rates of specimen adequacy [ Time Frame: 24 hours ]
    Inadequate specimen - defined as biopsy specimens from which a definitive histological diagnosis cannot be rendered by the pathologist.

  4. Cross over [ Time Frame: 1 week, 30 days ]
    The rate of crossover to the other treatment arm will be documented

  5. Procedure duration [ Time Frame: 24 hours ]
    The total length of time for the procedure will be documented in minutes.

  6. Rate of adverse events [ Time Frame: 24 hours, 1 week, 30 days ]
    The subject will be asked to report and medical records will be reviewed for any adveerse events related to the procedure.

  7. Procedural costs [ Time Frame: 30 days ]
    The subject's account will be reviewed for total costs associated with the procedure.

  8. Pain scores [ Time Frame: 24 hours, 1 week, 30 days ]
    Pain scores measured using the Visual Analog Scale (VAS) on a scale of 0 - 10 with 0 representing no pain and 10 representing the worst pain the subject has ever had; before and after biopsy has been performed.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All patients referred for liver biopsy for any reason
  2. Informed consent obtained from the patient
  3. ≥ 18 years old
  4. Able to undergo conscious sedation for EUS procedure

Exclusion Criteria:

  1. <18 years old
  2. Unable to obtain informed consent from the patient
  3. Medically unfit for sedation
  4. Pregnant patients
  5. Presence of a mass lesion in the liver requiring biopsy visualized on cross-sectional imaging
  6. Irreversible coagulopathy as determined by platelet count < 50,000 mm3 or International Normalized Ratio (INR) > 1.5
  7. Unable to stop anticoagulation or anti-platelet therapy for 5 days prior to the procedure
  8. Hemophilia
  9. Presence of an alternative etiology for elevated liver tests seen during liver biopsy, e.g. choledocholithiasis discovered during EUS examination
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Shyam Varadarajulu, MD 407.303.2570 shyam.varadarajulu.md@adventhealth.com
Contact: Robin Barron, RN, MSN 407.303.5503 robin.barron@adventhealth.com

Locations
Layout table for location information
United States, Florida
Center for Interventional Endoscopy Recruiting
Orlando, Florida, United States, 32803
Contact: Shyam Varadarajulu, MD    407-303-2750    Shyam.Varadarajulu.MD@flhosp.org   
Contact: Robin E Barron-Nelson, RN, MSN    407.303.5503    Robin.Barron@flhosp.org   
Sponsors and Collaborators
AdventHealth
Investigators
Layout table for investigator information
Principal Investigator: Shyam Varadarajulu, MD AdventHealth
Tracking Information
First Submitted Date  ICMJE June 5, 2019
First Posted Date  ICMJE July 1, 2019
Last Update Posted Date November 18, 2020
Actual Study Start Date  ICMJE July 25, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2019) 		Diagnostic adequacy of the tissue sample [ Time Frame: 24 hours ]
The primary outcome of the randomized trial is to compare between EUS-LB and PC-LB, the rate of procurement of diagnostically adequate specimens, defined as the presence of both maximum specimen length ≥ 25mm AND total no. of complete portal tracts ≥ 11.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2020)
  • Specimen length [ Time Frame: 24 hours ]
    Maximum specimen length in millimeters after formalin fixation will be documented.
  • Portal tracts [ Time Frame: 24 hours ]
    The total number of complete portal tracts for each biopsy specimen will be documented.
  • Rates of specimen adequacy [ Time Frame: 24 hours ]
    Inadequate specimen - defined as biopsy specimens from which a definitive histological diagnosis cannot be rendered by the pathologist.
  • Cross over [ Time Frame: 1 week, 30 days ]
    The rate of crossover to the other treatment arm will be documented
  • Procedure duration [ Time Frame: 24 hours ]
    The total length of time for the procedure will be documented in minutes.
  • Rate of adverse events [ Time Frame: 24 hours, 1 week, 30 days ]
    The subject will be asked to report and medical records will be reviewed for any adveerse events related to the procedure.
  • Procedural costs [ Time Frame: 30 days ]
    The subject's account will be reviewed for total costs associated with the procedure.
  • Pain scores [ Time Frame: 24 hours, 1 week, 30 days ]
    Pain scores measured using the Visual Analog Scale (VAS) on a scale of 0 - 10 with 0 representing no pain and 10 representing the worst pain the subject has ever had; before and after biopsy has been performed.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • Specimen length [ Time Frame: 24 hours ]
    Maximum specimen length in millimeters after formalin fixation will be documented.
  • Portal tracts [ Time Frame: 24 hours ]
    The total number of complete portal tracts for each procedure will be documented.
  • Rates of specimen adequacy [ Time Frame: 24 hours ]
    Inadequate specimen - defined as biopsy specimens from which a definitive histological diagnosis cannot be rendered by the pathologist.
  • Cross over [ Time Frame: 1 week, 30 days ]
    The rate of crossover to the other treatment arm will be documented
  • Procedure duration [ Time Frame: 24 hours ]
    The total length of time for the procedure will be documented in minutes.
  • Rate of adverse events [ Time Frame: 24 hours, 1 week, 30 days ]
    The subject will be asked to report and medical records will be reviewed for any adveerse events related to the procedure.
  • Procedural costs [ Time Frame: 30 days ]
    The subject's account will be reviewed for total costs associated with the procedure.
  • Pain scores [ Time Frame: 24 hours, 1 week, 30 days ]
    Pain scores measured using the Visual Analog Scale (VAS) on a scale of 0 - 10 with 0 representing no pain and 10 representing the worst pain the subject has ever had; before biopsy and prior to discharge.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endoscopic Ultrasound vs Percutaneous Route for Liver Biopsy
Official Title  ICMJE Randomized Trial Comparing Endoscopic Ultrasound-guided Liver Biopsy vs. Percutaneous Liver Biopsy
Brief Summary This study is to evaluate and directly compare the technical success, tissue quality, diagnostic efficacy and safety profile of Percutaneous and Endoscopic Ultrasound-guided Liver Biopsy.
Detailed Description Liver biopsy (LB) is essential for the diagnosis and evaluation of a variety of hepatic conditions, such as grading/staging of chronic liver disease secondary to alcohol, non-alcoholic steatohepatitis, viral hepatitis, hemochromatosis, Wilson's disease, cholestatic liver disease, as well as in elucidating the etiology of elevation in liver tests.1 Since it was first performed in 1883, percutaneous (PC) liver biopsy has become routine practice and is usually performed under the guidance of real-time imaging using transabdominal ultrasound (US) or computed tomography (CT).1,2 However, in recent times, liver biopsy has been increasingly performed via transgastric or transduodenal routes under endoscopic ultrasound (EUS) guidance. The perceived advantages of performing EUS-LB compared to PC-LB are the ability to simultaneously assess other organs such as common bile duct and pancreas, access to both left and right lobes of the liver and the routine use of conscious sedation during EUS procedures.3 Although single arm cohort studies and retrospective comparative studies assessing the technical success, tissue quality and safety of these different liver biopsy modalities exist, currently there are no randomized trials comparing PC and EUS-guided LB.4-7
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This is a randomized trial comparing two methods for procuring liver biopsy: 1) EUS-guided and 2) percutaneous.
Masking: Single (Care Provider)
Masking Description:
The pathologist will be blinded to the procedure received by the patient.
Primary Purpose: Diagnostic
Condition  ICMJE Liver Biopsy
Intervention  ICMJE Diagnostic Test: biopsy
Liver biopsy (LB) is essential for the diagnosis and evaluation of a variety of hepatic conditions, such as grading/staging of chronic liver disease secondary to alcohol, non-alcoholic steatohepatitis, viral hepatitis, hemochromatosis, Wilson's disease, cholestatic liver disease, as well as in elucidating the etiology of elevation in liver tests.
Study Arms  ICMJE
  • Active Comparator: Percutaneous Biopsy

    The subject would undergo the standard of care procedure for a percutaneous biopsy of the liver.

    All percutaneous biopsies will be performed after administration of local anesthetic. No pre-procedure antibiotics will be administered. Subcostal or subxyphoid area will be cleaned and draped in the standard manner. 2% lidocaine solution will be injected subcutaneously using a 25-gauge needle and then administered into the subcutaneous tissue up to the liver capsule. A 16-gauge biopsy needle is inserted into the liver parenchyma under US or CT-guidance, with the location of needle placement left to the discretion of the performing radiologist. One or two core biopsy samples will be obtained. All procured specimens will be placed in a single specimen container of 10% formalin for tissue processing. When biopsy samples have been obtained, the patient will be taken to the recovery area for post-procedure monitoring.

    Intervention: Diagnostic Test: biopsy
  • Active Comparator: Endoscopic-guided Ultrasound Biopsy

    The subject would undergo the standard of care procedure for an endoscopic-guided biopsy of the liver.

    The left lobe of the liver is identified from the gastric lumen, EUS-guided fine needle biopsy (FNB) will be performed using a 19-gauge FNB needle, with the choice of needle type at the discretion of the performing endoscopist. Stylet will only be used to puncture the liver at the time of the first pass and then subsequently removed. No suction will be used. Fanning technique will not be used. A total of 10 to-and-fro needle movements will be performed during each pass. A total of two passes will be performed.All tissue specimens procured will be placed in a single specimen container of 10% formalin for tissue processing. When two passes are complete under EUS-guidance, the echoendoscope will be withdrawn from the patient and the patient will be taken to the recovery area for post-procedure monitoring.

    Intervention: Diagnostic Test: biopsy
Publications *
  • Bravo AA, Sheth SG, Chopra S. Liver biopsy. N Engl J Med. 2001 Feb 15;344(7):495-500. Review.
  • 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.
  • Diehl DL. Endoscopic Ultrasound-guided Liver Biopsy. Gastrointest Endosc Clin N Am. 2019 Apr;29(2):173-186. doi: 10.1016/j.giec.2018.11.002. Epub 2019 Feb 2. Review.
  • Pineda JJ, Diehl DL, Miao CL, Johal AS, Khara HS, Bhanushali A, Chen EZ. EUS-guided liver biopsy provides diagnostic samples comparable with those via the percutaneous or transjugular route. Gastrointest Endosc. 2016 Feb;83(2):360-5. doi: 10.1016/j.gie.2015.08.025. Epub 2015 Aug 22.
  • Tublin ME, Blair R, Martin J, Malik S, Ruppert K, Demetris A. Prospective Study of the Impact of Liver Biopsy Core Size on Specimen Adequacy and Procedural Complications. AJR Am J Roentgenol. 2018 Jan;210(1):183-188. doi: 10.2214/AJR.17.17792. Epub 2017 Nov 1.
  • Hall TC, Deakin C, Atwal GS, Singh RK. Adequacy of percutaneous non-targeted liver biopsy under real-time ultrasound guidance when comparing the Biopince™ and Achieve™ biopsy needle. Br J Radiol. 2017 Dec;90(1080):20170397. doi: 10.1259/bjr.20170397. Epub 2017 Oct 3.
  • Mohan BP, Shakhatreh M, Garg R, Ponnada S, Adler DG. Efficacy and safety of EUS-guided liver biopsy: a systematic review and meta-analysis. Gastrointest Endosc. 2019 Feb;89(2):238-246.e3. doi: 10.1016/j.gie.2018.10.018. Epub 2018 Oct 31.
  • Wyatt J, Hubscher S, Bellamy C. Tissue pathways for liver biopsies for the investigation of medical disease and for focal lesions. London, UK: The Royal College of Pathologists; 2014.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 16, 2020) 		40
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2019) 		130
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. All patients referred for liver biopsy for any reason
  2. Informed consent obtained from the patient
  3. ≥ 18 years old
  4. Able to undergo conscious sedation for EUS procedure

Exclusion Criteria:

  1. <18 years old
  2. Unable to obtain informed consent from the patient
  3. Medically unfit for sedation
  4. Pregnant patients
  5. Presence of a mass lesion in the liver requiring biopsy visualized on cross-sectional imaging
  6. Irreversible coagulopathy as determined by platelet count < 50,000 mm3 or International Normalized Ratio (INR) > 1.5
  7. Unable to stop anticoagulation or anti-platelet therapy for 5 days prior to the procedure
  8. Hemophilia
  9. Presence of an alternative etiology for elevated liver tests seen during liver biopsy, e.g. choledocholithiasis discovered during EUS examination
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shyam Varadarajulu, MD 407.303.2570 shyam.varadarajulu.md@adventhealth.com
Contact: Robin Barron, RN, MSN 407.303.5503 robin.barron@adventhealth.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04003766
Other Study ID Numbers  ICMJE 1438608
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share IPD.
Responsible Party AdventHealth
Study Sponsor  ICMJE AdventHealth
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shyam Varadarajulu, MD AdventHealth
PRS Account AdventHealth
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯