Benign Liver Optimal Core Study (Tissue Acquisition Comparison in Benign Liver Disease)
Completed · Not applicable
Conditions studied: Liver Diseases
In brief
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).
Key facts
- Study ID
- NCT03245580
- Run by
- Parkview Health
- People needed
- 153
- Starts
- 2018-03-08
- Expected to finish
- 2020-09-15
- Last updated by the study team
- 2022-04-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University South Alabama — Mobile, Alabama, United States
- Santa CLara Valley Medical Center — San Jose, California, United States
- Parkview Regional Medical Center — Fort Wayne, Indiana, United States
- Indiana University — Indianapolis, Indiana, United States
- Oschner Health System — New Orleans, Louisiana, United States
- Geisinger Medical Center — Danville, Pennsylvania, United States
- Baylor Medical Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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