Skip to main content
OpenTrials
Completed

NCT Number: NCT03245580

Benign Liver Optimal Core Study (Tissue Acquisition Comparison in Benign Liver Disease)

The primary purpose of this prospective, randomized, multicenter study is to evaluate and compare the amount and quality of tissue samples yielded in a liver biopsy comparing 2 different techniques of EUS guided CORE liver biopsy for benign disease. The two techniques: "modified Wet suction" and "Slow pull" technique of collecting tissue from a liver biopsy via Endoscopic Ultrasound (EUS).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Liver Diseases Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University South Alabama, Mobile, Alabama, United States

Loading trial locations.

About this study

Each subject will have a biopsy performed via one of 2 different techniques: "modified wet suction", or "slow pull" technique. A randomization process will determine which technique. Each subject shall undergo 2 passes (2 cores of tissue will be obtained - ideally from the right and left lobe of the liver.

Quality of tissue obtained via the 2 different techniques will be evaluated by number of fragments, length of specimens and number of tracts observed by the local pathologist and compared between the tissues obtained from the two techniques. .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects that plan to undergo a liver biopsy via EUS to confirm possible underlying liver disease or to determine stage, grade and presence of fibrosis for suspected benign etiology.
  • History of abnormal LFTs
  • Documented history of chronic liver disease
  • Question of underlying liver disease as cause of abnormal imaging or symptoms which may be attributed to liver disorder
  • Fatty liver disease
  • Subjects 18 years of age or older
  • Subject must be able to hold anticoagulants as per institutional standard of care
  • Subjects must be deemed physically able to undergo anesthesia. This includes either Monitored Anesthesia Care (MAC) or general anesthesia.
  • Subjects (or the subjects Legally Authorized Representative [LAR]) that have agreed to participate in the study and have signed Informed Consent
  • Women of child bearing potential who are not pregnant as proven by a negative pregnancy test may be included.

Exclusion criteria

  • Subjects that are unable to tolerate anesthesia for the procedure
  • Subjects 17 or under
  • Subjects whose anticoagulants cannot be held
  • Subjects who cannot have or refuse EUS guided procedure
  • Subjects who are pregnant
  • INR >1.5
  • Platelets 50,000 or less
  • Subjects requiring control of bleeding on initial upper endoscopy
  • Subjects requiring endoscopic mucosal resection
  • Subjects with large volume ascites
  • Subjects requiring pancreatic biopsies

Treatment and study plan

Core Liver Biopsy

Diagnostic Test

Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.

Primary outcomes

  1. Pathological Yield Fragmentation

    Time frame: At day 7 post biopsy

    To determine if there is a significant difference in pathological yield as determined by fragmentation of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. Pathological yield will be measured by assessment of portal tracts fragmentation by designated pathologists with experience in liver biopsy specimens.

  2. Pathological Yield Length

    Time frame: At time of completion of pathology report

    To determine if there is a significant difference in pathological yield as determined by length of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. Length of portal tracts will be measured in mm by designated pathologists with experience in liver biopsy assessment techniques.

  3. Pathological Yield Quantity

    Time frame: At time of completion of pathology report

    To determine if there is a significant difference in pathological yield as determined by number of portal tracts of the biopsy sample between a "modified wet suction," and "slow pull" techniques in obtaining CORE of histologic tissue. The number of portal tracts will be assesses and tallied by designated pathologists with experience in the assessment of liver biopsies.

Secondary outcomes

  1. Complications

    Time frame: Complications occurring at time of consent, at procedure time and at day 7 post procedure

    Tracking any complications that may be associated with each technique. Complications will be assessed and tracked following CTCAE V4.

Sponsors and collaborators

Lead sponsor

Parkview Health

Other

Registry information

Official study title

Comparison of 2 Techniques Using EUS Guided Liver Biopsies Via 19g CORE Biopsy Needle to Obtain Optimal Core Liver Biopsies in Benign Disease

Acronym: BLOCS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 10, 2017
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.