Wet Heparin for Obtaining Liver Tissue for EUS Guided Liver Biopsy

NCT03103997 | Completed DMC

• 1 other identifier: 2016-0300
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Since its inception, endoscopic ultrasound with fine needle aspiration (EUS-FNA) has proven a valuable diagnostic and prognostic tool for evaluating a diverse number of pathologies. One such pathology is chronic liver disease (CLD), for which EUS-guided liver biopsy has become a well-accepted method for tissues acquisition. EUS-LB also been compared with percutaneous and transguluar routes showing at least comparable ability to obtain adequate tissue for CLD. Though enhancements to EUS-FNA, such as dry suction, stylet pull have not proven to demonstrate increased diagnostic accuracy for EUS-FNA, the use of wet suction technique (WEST) has demonstrated the ability to obtain more cellular tissue samples with less blood contamination. In an attempt to obtain further improvement in tissue adequacy, with less blood contamination for EUS-LB, the use of wet heparinized needles will be investigated as compared with conventional EUS-LB for patients with CLD. To do this subjects shall be selected to undergo EUS-LB. As it is the standard to perform 3 needle passes during EUS-LB, subjects will undergo one pass with the following designations: pass 1: conventional EUS-LB \[no flush\], pass 2: dry heparin heparin \[5 milliliters (mL) of heparin flushed and then flushed with air\], and pass 3: wet heparin \[5 milliliters (mL) of heparin flushed and retained in the needle\]. It is predicted that specimens collected with heparinized needle shall show improved adequacy compared with conventional EUS-LB. It is also predicted that the heparin wash will lead to less blood contamination compared with conventional methods. Subjects shall also be monitored for adverse events (AE).

Conditions

Liver Diseases

Keywords

Liver; EUS; Biopsy; Heparin

Outcome Measures

Primary Outcomes (1)

• Proportion of cases for which a histologic diagnosis could be made based upon Proportion of cases for which a histologic diagnosis could be made based upon the amount of tissue obtained with the needle

  Proportion of cases for which a histologic diagnosis could be made based upon the amount of tissue obtained with the needle

  7 days

Secondary Outcomes (9)

• The Number of patients with a visible core after needle biopsy

  Presence of a visible core specimen (yes/no) at time 7 days

• The Number of patients with a visible clot after needle biopsy

  Presence of visible clots in specimen (yes/no) at time 7 days

• 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 (3)

New Needle

ACTIVE COMPARATOR

EUS-guided liver biopsy with needle and suction, no preparation

Procedure: EUS-guided liver biopsy

Dry Heparin

EXPERIMENTAL

EUS-guided liver biopsy with needle flushed with heparin, then flushed with air, suction then attached

Procedure: EUS-guided liver biopsy

Wet Heparin

EXPERIMENTAL

EUS-guided liver biopsy with needle flushed with heparin, 2 cc of liquid added to suction then attached.

Procedure: EUS-guided liver biopsy

Interventions

EUS-guided liver biopsy PROCEDURE

EUS-guided liver biopsy using needles with various preparations

Dry Heparin; New Needle; Wet Heparin

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
• Patients with a heparin or porcine allergy
• Patients with prior heparin induced thrombocytopenia (HIT)
• Patient's with religious aversion to porcine-containing products

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Related Publications (38)

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MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• David L Diehl, M.D.

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants undergo each biopsy in the protocol. The care provider will be directing and performing each needle pass. The outcome assessor will be unaware of each group.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects enrolled will undergo EUS-guided biopsies in the following manner. First pass needle out of package without preparation and full suction. Second pass: needle flushed with heparin, then flushed with air and suction, dry heparin. Third pass: needle flushed with heparin and then 2 cc of liquid added to suction syringe and attached, wet heparin.

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: April 7, 2017
• Study Start: January 6, 2017
• Primary Completion: June 1, 2018
• Study Completion: June 30, 2018
• Last Updated: August 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)