Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Registry

NCT05817994 | Withdrawn DMC

• 1 other identifier: 313
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patient Registry aiming to provide regional evidence documenting the clinical merit of EUS (Endoscopic\_ Ultrasound) guided liver biopsy, per local standard of practice, in patients with suspected liver disease indicated for an endoscopic intervention and a liver biopsy.

Conditions

Liver Diseases; Liver Neoplasms; Liver Dysfunction; Liver Failure, Acute; Liver Fibrosis; Liver Inflammation

Keywords

liver; endoscopy; Biopsy; Ultrasound; EUS liver Biopsy

Outcome Measures

Primary Outcomes (2)

• Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy [Phase 1]

  Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy in the setting of suspected liver disease from three months prior, to 30 days after the first upper Endoscopy procedure on study \[ Phase 1\]

  30 Days in Phase 1

• Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy [Phase 2]

  Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy in the setting of suspected liver disease from three months prior, to 12 months after the first upper Endoscopy procedure on study \[ Phase 2\]

  12 months in phase 2

Secondary Outcomes (4)

• Number of serious adverse events

  30 days (Phase 1), 12 months (Phase 2)

• Number of Participants with Laboratory Abnormalities in Liver function Tests

  from baseline to 6 months and from baseline to 12 months [Phase 2]

• Number of Participants with Noninvasive Liver Imaging abnormalities

  from baseline to 6 months and from baseline to 12 months [Phase 2]

• Number of diagnostic liver biopsies

  13 months (phase 1 and 2)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll patients with suspected liver disease that are indicated for upper endoscopy for the assessment for esophageal varices and liver biopsy as per the local standard of care.

You may qualify if:

• Adult (per local age threshold)
• Suspected liver disease based on abnormal liver function tests, standard ultrasound, transient elastography (Fibro Scan) or CT or MRI of the liver
• Planned upper endoscopy to evaluate for varices
• Planned liver biopsy based on suspected hepatitis or cirrhosis

You may not qualify if:

• Severe Coagulation/bleeding disorder as defined by INR \> 2 IU which cannot be corrected with FFP or Platelets \< 50,000 per microliter which cannot be corrected with platelet transfusion.
• Severe organ failure considered unsafe to undergo sedation (ASA class 4 or 5)
• Inability to provide informed consent

Sponsors & Collaborators

• Sheikh Shakhbout Medical City: lead
• Boston Scientific Corporation: collaborator

Related Publications (9)

• Asrani SK, Devarbhavi H, Eaton J, Kamath PS. Burden of liver diseases in the world. J Hepatol. 2019 Jan;70(1):151-171. doi: 10.1016/j.jhep.2018.09.014. Epub 2018 Sep 26.

  PMID: 30266282 BACKGROUND

• Morales-Ruiz, Manuel, et al.

  BACKGROUND

• Baran B, Kale S, Patil P, Kannadath B, Ramireddy S, Badillo R, DaVee RT, Thosani N. Endoscopic ultrasound-guided parenchymal liver biopsy: a systematic review and meta-analysis. Surg Endosc. 2021 Oct;35(10):5546-5557. doi: 10.1007/s00464-020-08053-x. Epub 2020 Oct 14.

  PMID: 33052529 BACKGROUND

• Ali AH, Panchal S, Rao DS, Gan Y, Al-Juboori A, Samiullah S, Ibdah JA, Hammoud GM. The efficacy and safety of endoscopic ultrasound-guided liver biopsy versus percutaneous liver biopsy in patients with chronic liver disease: a retrospective single-center study. J Ultrasound. 2020 Jun;23(2):157-167. doi: 10.1007/s40477-020-00436-z. Epub 2020 Mar 5.

  PMID: 32141043 BACKGROUND

• Bang JY, Ward TJ, Guirguis S, Krall K, Contreras F, Jhala N, Navaneethan U, Hawes RH, Varadarajulu S. Radiology-guided percutaneous approach is superior to EUS for performing liver biopsies. Gut. 2021 Dec;70(12):2224-2226. doi: 10.1136/gutjnl-2021-324495. Epub 2021 Mar 25. No abstract available.

  PMID: 33766911 BACKGROUND

• ASGE Technology Committee; Trikudanathan G, Pannala R, Bhutani MS, Melson J, Navaneethan U, Parsi MA, Thosani N, Trindade AJ, Watson RR, Maple JT. EUS-guided portal vein interventions. Gastrointest Endosc. 2017 May;85(5):883-888. doi: 10.1016/j.gie.2017.02.019. Epub 2017 Mar 18. No abstract available.

  PMID: 28320514 BACKGROUND

• Samarasena JB, Chang KJ. Endoscopic Ultrasound-Guided Portal Pressure Measurement and Interventions. Clin Endosc. 2018 May;51(3):222-228. doi: 10.5946/ce.2018.079. Epub 2018 May 31.

  PMID: 29874904 BACKGROUND

• Huang JY, Samarasena JB, Tsujino T, Lee J, Hu KQ, McLaren CE, Chen WP, Chang KJ. EUS-guided portal pressure gradient measurement with a simple novel device: a human pilot study. Gastrointest Endosc. 2017 May;85(5):996-1001. doi: 10.1016/j.gie.2016.09.026. Epub 2016 Sep 29.

  PMID: 27693644 BACKGROUND

• Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.

  PMID: 20189503 BACKGROUND

MeSH Terms

Conditions

Liver Diseases; Liver Neoplasms; Liver Failure, Acute; Liver Cirrhosis; Hepatitis

Condition Hierarchy (Ancestors)

Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Liver Failure; Hepatic Insufficiency; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2023
• First Posted: April 18, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: November 19, 2024

Record last verified: 2023-04