NCT03245580

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Parkview Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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. .

Conditions

• Liver Diseases

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Core Liver Biopsy	Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.

Timeline

• Start date: 2018-03-08
• Primary completion: 2020-09-15
• Completion: 2020-09-15
• First posted: 2017-08-10
• Last updated: 2022-04-07
• Results posted: 2022-04-07

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study