N/A
Completed N=20
19 Versus 22-Gauge Needle for EUS-LB
Diagnoses Diseases · Ultrasound Therapy; Complications · Liver disease
Source: ClinicalTrials.gov NCT02967991 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Number of Specimens for Which a Histologic Diagnosis Could be Made Based Upon the Amount of Tissue Obtained With the Needle — 17; 14 specimens
Summary
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-gauge needle, therefore in this study the investigators hope to compare the tissue yields of a 22-gauge fine needle biopsy (FNB) needle, in comparison to conventional 19-gauge. The investigators predict that 19 and 22 gauge FNB needle will demonstrate similar diagnostic accuracy, with less visible blood artifact. Similarly the investigators predict the safety to be equal.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Specimens for Which a Histologic Diagnosis Could be Made Based Upon the Amount of Tissue Obtained With the Needle |
17; 14 | — |
| SECONDARY The Number of Specimens With a Visible Core After Needle Biopsy |
20; 19 | — |
| SECONDARY The Number of Specimens With a Visible Clot After Needle Biopsy |
4; 1 | — |
| SECONDARY The Number of Patients With Visible Bleeding After Needle Biopsy |
— | — |
| SECONDARY The Number of Patients With Pain 1 Day After Needle Biopsy |
— | — |
| SECONDARY The Number of Patients With Pain 7 Day After Needle Biopsy |
1 | — |
| SECONDARY The Number of Patients Requiring Medical Care After Needle Biopsy |
1 | — |
| SECONDARY Number of Portal Tracts (PT) in the Specimen (Total) Under Histologic Examination |
7.4; 6.1 | — |
| SECONDARY Aggregate Specimen Length Under Histologic Examination |
76.5; 66.9 | — |
| SECONDARY Length of the Longest Piece Under Histologic Examination |
13.2; 10.8 | — |
Eligibility Criteria
Inclusion Criteria
- Patients undergoing EUS-LB
- Platelet count > 50,000
- International normalized ratio (INR) 18 years
- Non-pregnant patients
Exclusion Criteria
- Age 1.5
- Presence of ascites
- Known liver cirrhosis
Data sourced from ClinicalTrials.gov (NCT02967991). 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. Informational only — not medical advice.