Comparison and Outcomes of Endoscopic Ultrasound Liver Biopsies Versus Percutaneous Liver Biopsies

NCT04751045 | Completed

• 1 other identifier: 2013389
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Histopathological examination of liver tissue is used to determine the etiology and extent of liver disease. In order for a clinician to make a better-informed decision regarding a patient with liver disease, the liver biopsy specimen has to be adequate and of high quality for pathological interpretation. It is generally agreed that an adequate liver biopsy has to have ≥6-12 intact portal tracts for pathological review and interpretation.(1) Historically, three approaches have been used to obtain a liver biopsy: percutaneous, transjugular (TJ-LB) and laparoscopic approach (LA-LB)- with percutaneous liver biopsy (P-LB) being the most commonly employed. Endoscopic ultrasound-guided liver biopsy (EUS-LB), a newer approach, is now being performed by select skilled endoscopists across the country. EUS-LB is advantageous over existing techniques because it enables visualization and avoidance of vessels that are 1mm in diameter, provides access to both lobes of the liver and theoretically is less painful due to avoiding somatic pain fibers. Further, in patients that are already undergoing esophagogastroduodenoscopy, EUS-LB can be performed simultaneously and spare the patient an additional procedure. Because of the plausibility of reduced pain, number of procedures and possibly complications, EUS-LB may be cost-effective over existing methods. There is limited data evaluating the safety and efficacy of EUS-LB versus percutaneous liver biopsy. The investigators hope to provide answers in a prospective study comparing between patients, who are already undergoing liver biopsy, randomly assigned to either EUS-LB or P-LB. The investigators will compare outcomes such as pain, bleeding, hospitalization, and tissue diagnosis between the two groups. This will allow us to add to the existing data for the use of EUS-LB. If patients are found to have less adverse events and better outcomes using EUS-LB versus percutaneous-LB this may become the preferred method of diagnosis in this patient population.

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

• portal tracts obtained

  the number of complete portal tract obtained in a biopsy between EUS vs. the percutaneous approach.

  1 year

Secondary Outcomes (7)

• Length of liver specimen.

  1 year

• Pain score

  Score will be calculated subjectively at the time of discharge after the biopsy and again in 24-48 hours after the procedure

• Opiates consumed (in milligrams) per patients

  This will be recorded at the time of discharge after the biopsy and again in 24-48 hours after the procedure

• Readmission rate related to the procedure

  Investigators will follow up the patient in 1 week duration to note any adverse events/complication that might have caused patient to get admitted to the hospital

• Details of the liver biopsy procedure

  Investigators will follow up and obtain this information within 1 month after the procedure

Study Arms (2)

Percutaneous Liver biopsy

ACTIVE COMPARATOR

Technique: The preprocedure "time out" protocol will be completed prior to initiation of the procedure. The patient will be positioned supine and right hepatic lobe was localized with ultrasound. Conscious sedation with Versed and fentanyl will be initiated and the patient's vital signs were monitored by an independent trained observer during the procedure. After placing a mark on the skin overlying the right upper quadrant, the skin was then prepped and draped in the usual sterile fashion. Maximum sterile barrier technique used at the procedure. Under direct sonographic guidance, a 15 gauge percutaneous liver biopsy needle will be used with a 2 cm throw was advanced into the right hepatic lobe. The biopsy samples will be obtained and submitted to pathology.

Procedure: EUS liver biopsy

Endoscopic ultrasound guided liver biopsy

ACTIVE COMPARATOR

Procedure details: patients will be screened preoperatively to assess cardiovascular health prior to undergoing procedure as this is standard of care. Patients will follow all standard preoperative instructions prior to anesthesia. Upon undergoing general anesthesia, a videoendoscope will be introduced into the esophagus under direct vision. Once endoscope is in position near the liver, a 19-gauge sharkcore needle will be used to puncture the left lobe with a 3 accentuation and another pass from right lobe with 4 accentuation. Doppler study will be used to interrogate for any significant doppler signals in needle path. Post procedure, patients will be provided instructions to avoid NSAIDs for 4 days and perform lightweight activity for 4 days. Patients will be observed for bleeding and significant abdominal pain postoperatively

Procedure: EUS liver biopsy

Interventions

EUS liver biopsy PROCEDURE

Endoscopic ultrasound guided liver biopsy

Endoscopic ultrasound guided liver biopsy; Percutaneous Liver biopsy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients ≥ 18 years of age
• subjects undergoing a liver biopsy for focal/diffuse abnormalities of the liver
• parenchymal disease or chronically elevated liver function tests
• for assessing degree of fibrosis in chronic liver diseases
• or any indication deemed as necessary per the hepatologist/physician

You may not qualify if:

• Age \<18
• Coagulopathy (INR of ≥1.5 and/or platelet count ≤ 50,000)
• Use of anticoagulants and/or blood thinners within 24 hours before the planned procedure
• Liver lesions such as hemangioma, echinococcal cyst or vascular tumors,
• Pregnancy,
• Uncooperative patients
• Any other condition or abnormalities that, in the opinion of the referring hepatologist or the advanced endoscopist, may compromise the safety of the patient or interfere with the patient participating in or completing the study.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Hospital

Columbia, Missouri, 65212, United States

Location

Related Publications (14)

• 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 BACKGROUND

• 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 BACKGROUND

• Shah ND, Sasatomi E, Baron TH. Endoscopic Ultrasound-guided Parenchymal Liver Biopsy: Single Center Experience of a New Dedicated Core Needle. Clin Gastroenterol Hepatol. 2017 May;15(5):784-786. doi: 10.1016/j.cgh.2017.01.011. Epub 2017 Jan 23. No abstract available.

  PMID: 28126424 BACKGROUND

• Nieto J, Khaleel H, Challita Y, Jimenez M, Baron TH, Walters L, Hathaway K, Patel K, Lankarani A, Herman M, Holloman D, Saab S. EUS-guided fine-needle core liver biopsy sampling using a novel 19-gauge needle with modified 1-pass, 1 actuation wet suction technique. Gastrointest Endosc. 2018 Feb;87(2):469-475. doi: 10.1016/j.gie.2017.05.013. Epub 2017 May 24.

  PMID: 28551024 BACKGROUND

• Krupa L, Staron R, Pajak J, Lammert F, Krawczyk M, Gutkowski K. Secondary systemic amyloidosis diagnosed by endoscopic ultrasound-guided liver biopsy. J Gastrointestin Liver Dis. 2018 Mar;27(1):101-102. doi: 10.15403/jgld.2014.1121.271.kru. No abstract available.

  PMID: 29557423 BACKGROUND

• Fally M, Nessar R, Behrendt N, Clementsen PF. Endoscopic Ultrasound-Guided Liver Biopsy in the Hands of a Chest Physician. Respiration. 2016;92(1):53-5. doi: 10.1159/000446924. Epub 2016 Jun 8.

  PMID: 27287428 BACKGROUND

• Parekh PJ, Majithia R, Diehl DL, Baron TH. Endoscopic ultrasound-guided liver biopsy. Endosc Ultrasound. 2015 Apr-Jun;4(2):85-91. doi: 10.4103/2303-9027.156711.

  PMID: 26020041 BACKGROUND

• Lee YN, Moon JH, Kim HK, Choi HJ, Choi MH, Kim DC, Lee TH, Lee TH, Cha SW, Kim SG, Kim YS. Usefulness of endoscopic ultrasound-guided sampling using core biopsy needle as a percutaneous biopsy rescue for diagnosis of solid liver mass: Combined histological-cytological analysis. J Gastroenterol Hepatol. 2015 Jul;30(7):1161-6. doi: 10.1111/jgh.12922.

  PMID: 25684303 BACKGROUND

• Johal AS, Khara HS, Maksimak MG, Diehl DL. Endoscopic ultrasound-guided liver biopsy in pediatric patients. Endosc Ultrasound. 2014 Jul;3(3):191-4. doi: 10.4103/2303-9027.138794.

  PMID: 25184126 BACKGROUND

• 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 BACKGROUND

• Vegesna A, Nazir A, Chung CY, Kane S, Thomas R, Miller L. Acoustic liver biopsy in patients with hepatitis C and advanced liver fibrosis using endoscopic ultrasound. Dig Dis Sci. 2011 Oct;56(10):3053-7. doi: 10.1007/s10620-011-1670-6. Epub 2011 Apr 1.

  PMID: 21455673 BACKGROUND

• Andanappa HK, Dai Q, Korimilli A, Panganamamula K, Friedenberg F, Miller L. Acoustic liver biopsy using endoscopic ultrasound. Dig Dis Sci. 2008 Apr;53(4):1078-83. doi: 10.1007/s10620-008-0211-4. Epub 2008 Feb 13.

  PMID: 18270828 BACKGROUND

• Hollerbach S, Willert J, Topalidis T, Reiser M, Schmiegel W. Endoscopic ultrasound-guided fine-needle aspiration biopsy of liver lesions: histological and cytological assessment. Endoscopy. 2003 Sep;35(9):743-9. doi: 10.1055/s-2003-41593.

  PMID: 12929021 BACKGROUND

• 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.

  PMID: 30389469 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Medicine

Model Details: Study the safety, efficacy of EUS guided liver biopsy in comparison to percutaneous liver biopsy

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: February 11, 2021
• Study Start: October 25, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)