19 Versus 22-Gauge Needle for EUS-LB

NCT02967991 | Completed Results DMC

• 1 other identifier: 2016-0281
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diagnoses Diseases; Ultrasound Therapy; Complications; Liver Diseases

Keywords

EUS; Biopsy; Liver; FNA; FNB

Outcome Measures

Primary Outcomes (1)

• Number of Specimens for Which a Histologic Diagnosis Could be Made Based Upon the Amount of Tissue Obtained With the Needle

  Defined by total portal structures \> 5 or length of the longest piece \> 15 mm) Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB. FNA-fine needle aspiration FNB-fine needle biopsy

  7 days

Secondary Outcomes (9)

• The Number of Specimens With a Visible Core After Needle Biopsy

  Day of Procedure

• The Number of Specimens With a Visible Clot After Needle Biopsy

  Day of Procedure

• The Number of Patients With Visible Bleeding After Needle Biopsy

  7 days

• The Number of Patients With Pain 1 Day After Needle Biopsy

  1 days

• The Number of Patients With Pain 7 Day After Needle Biopsy

  7 days

Study Arms (4)

19 Left

ACTIVE COMPARATOR

EUS-guided liver biopsy using a19-gauge liver biopsy in the left lobe

Device: EUS-guided liver biopsy

22 Left

EXPERIMENTAL

EUS-guided liver biopsy using a 22-gauge liver biopsy in the left lobe

Device: EUS-guided liver biopsy

19 Right

ACTIVE COMPARATOR

EUS-guided liver biopsy using a 19-gauge liver biopsy in the right lobe

Device: EUS-guided liver biopsy

22 Right

EXPERIMENTAL

EUS-guided liver biopsy using a 22-gauge liver biopsy in the right lobe

Device: EUS-guided liver biopsy

Interventions

EUS-guided liver biopsy DEVICE

Endoscopic ultrasound guided liver biopsy

19 Left; 19 Right; 22 Left; 22 Right

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing EUS-LB
• Platelet count \> 50,000
• International normalized ratio (INR) \< 1.5
• Age \> 18 years
• Non-pregnant patients

You may not qualify if:

• Age \< 18 years
• Pregnant Patients
• Inability to obtain consent
• Anticoagulants or anti-platelet agents use (excluding aspirin) within the last 7-10 days
• Platelet count \< 50,000
• INR \> 1.5
• Presence of ascites
• Known liver cirrhosis

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Related Publications (37)

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MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Limitations and Caveats

No blinding, single-center, no generalization to community, carrier effect with cross-over design, obesity, second pass.

Results Point of Contact

• Title: Shaffer Mok
• Organization: University Hospitals Case Western Reserve

Shaffer.Mok@UHHospitals.org

4404065500

Study Officials

• David L Diehl, M.D.

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 18, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 5, 2019
• Results First Posted: November 5, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)