Abnormal Liver Function Clinical Trial
Official title:
19-Gauge Fine Needle Aspirate (FNA) Versus 19-Gauge Fine Needle Biopsy (FNB) Needles for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB): A Randomized Prospective Trial
| Verified date | April 2020 |
| Source | Geisinger Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Chronic liver disorders (CLD) are a major cause of morbidity and mortality for individuals in the US. Though serologic analysis will often lead to a conclusive diagnosis, liver biopsy remains an important method for helping to determine the etiology and stage of LD. Percutaneous liver biopsy (PLB), transjugular liver biopsy (TLB) and surgical liver biopsy (SLB) are alternative methods for obtaining hepatic tissue. In recent years endoscopic ultrasound guided-liver biopsy (EUS-LB) has come to the forefront as a safe and effective method for obtaining tissue in CLD. There are several studies of the safety of EUS-LB as well as the adequacy of specimens obtained in this fashion. Most studies involve a 19-g needle, therefore in this study we hope to compare the tissue yields of a 19-g fine needle biopsy (FNB) needle, in comparison to conventional 19-g fine needle aspiration (FNA) needle. We predict that 19-g FNA and 19-g FNB needle will demonstrate similar diagnostic accuracy, with less visible blood artifact. Similarly, we predict the safety to be equal.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | August 17, 2018 |
| Est. primary completion date | August 17, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Patients undergoing EUS-LB 2. Platelet count > 50,000 3. International normalized ratio (INR) < 1.5 4. Age > 18 years 5. Non-pregnant patients Exclusion Criteria: 1. Age < 18 years 2. Pregnant patients 3. Inability to obtain consent 4. Anticoagulants or anti-platelet agents use (excluding aspirin) within the last 7-10 days 5. Platelet count < 50,000 6. INR > 1.5 7. Presence of ascites 8. Known liver cirrhosis 9. Hemophilia |
| Country | Name | City | State |
|---|---|---|---|
| United States | Geisinger Medical Center | Danville | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Geisinger Clinic |
United States,
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* Note: There are 27 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pre-processing Length of the Longest Piece (LLP) | Pre-processing Length of the longest piece (LLP) measured in centimeter | up to 5 days | |
| Secondary | Post-processing Length of the Longest Piece (LLP) | Post-processing Length of the longest piece (LLP) measured in centimeter | 3-5 days | |
| Secondary | Number of Participants With LLP Pre-processing Length Less Than 2 cm or Greater Than 2 cm | Pre-processing Length of the longest piece (LLP) subgroups: < 2 cm > 2cm |
3-5 days | |
| Secondary | Pre-processing Aggregate Specimen Length (ASL) | Pre-processing Aggregate specimen length (ASL) measured in centimeter | 3-5 days | |
| Secondary | Post-processing Aggregate Specimen Length (ASL) | Post-processing Aggregate specimen length (ASL) measured in centimeter | 3-5 days | |
| Secondary | Portal Triads Number (Mean) | Number of portal triads (PT) in the specimen. | 3-5 days | |
| Secondary | Portal Triads Quantity (Median) | Number of portal triads (PT) in the specimen. | 3-5 days | |
| Secondary | Number of Participants With Fewer Than 11 Portal Triads or More Than 11 Portal Triads | Portal triads groups, n (%) < 11 Portal triads > 11 Portal triads | 3-5 days | |
| Secondary | No. of Fragments > 9 mm, Mean (SD) | No. of fragments > 9 mm, mean (SD) Pre-processing Post-processing | 3-5 days | |
| Secondary | Specimen Quality for Histologic Diagnosis | Number of cases for which a histologic diagnosis could be made based upon the amount of tissue obtained with the needle. | 3-5 days | |
| Secondary | Length of Longest Piece | Number Analyzed |