N/A
N=153
Benign Liver Optimal Core Study (Tissue Acquisition Comparison in Benign Liver Disease)
Liver Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03245580 ↗Enrolled (actual)
153
Serious AEs
5.9%
Results posted
Apr 2022
Primary outcome: Primary: Pathological Yield Fragmentation — 14; 11; 13; 10 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Core Liver Biopsy (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Parkview Health
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathological Yield Fragmentation |
14; 11; 13; 10 | — |
| PRIMARY Pathological Yield Length |
46.5; 34.5; 38; 28 | — |
| PRIMARY Pathological Yield Quantity |
16; 11.5; 14; 12 | — |
| SECONDARY Complications |
10; 4; 1; 4; 2; 2 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03245580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.