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Wet Heparin for Obtaining Liver Tissue for EUS Guided Liver Biopsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103997
Recruitment Status : Completed
First Posted : April 7, 2017
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Geisinger Clinic

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).


Condition or disease Intervention/treatment Phase
Liver Diseases Procedure: EUS-guided liver biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Diagnostic
Official Title: Wet Heparinized Suction: A Novel Technique to Enhance Tissue Acquisition for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB): A Prospective Trial
Actual Study Start Date : January 6, 2017
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Heparin

Arm Intervention/treatment
Active Comparator: New Needle
EUS-guided liver biopsy with needle and suction, no preparation
Procedure: EUS-guided liver biopsy
EUS-guided liver biopsy using needles with various preparations

Experimental: Dry Heparin
EUS-guided liver biopsy with needle flushed with heparin, then flushed with air, suction then attached
Procedure: EUS-guided liver biopsy
EUS-guided liver biopsy using needles with various preparations

Experimental: Wet Heparin
EUS-guided liver biopsy with needle flushed with heparin, 2 cc of liquid added to suction then attached.
Procedure: EUS-guided liver biopsy
EUS-guided liver biopsy using needles with various preparations




Primary Outcome Measures :
  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 [ Time Frame: 7 days ]
    Proportion of cases for which a histologic diagnosis could be made based upon the amount of tissue obtained with the needle


Secondary Outcome Measures :
  1. The Number of patients with a visible core after needle biopsy [ Time Frame: Presence of a visible core specimen (yes/no) at time 7 days ]
    Day of Procedure

  2. The Number of patients with a visible clot after needle biopsy [ Time Frame: Presence of visible clots in specimen (yes/no) at time 7 days ]
    Day of Procedure

  3. The Number of patients with visible bleeding after needle biopsy [ Time Frame: 7 Days ]
    Patient with blood visible from patient's mouth, rectum with a 2 gram drop in hemoglobin

  4. The Number of patients with Pain 1 Day after needle biopsy [ Time Frame: 1 Days ]
    Pain using Likert score 0-10 (10 worst)

  5. The Number of patients with Pain 7 Day after needle biopsy [ Time Frame: 7 Days ]
    Pain using Likert score 0-10 (10 worst)

  6. The Number of patients requiring medical care after needle biopsy [ Time Frame: 7 Days ]
    Patient requiring visit to healthcare center (emergency room, hospital, call to service) within time 7 days

  7. Number of portal tracts (PT) in the specimen (total) under histologic examination [ Time Frame: 7 Days ]
    Number of portal tracts (PT) in the specimen (total) under histologic examination

  8. Aggregate Specimen Length under histologic examination [ Time Frame: 7 Days ]
    Length of all the tissue (centimeters) by adding the sum of all pieces

  9. Length of the longest piece under histologic examination [ Time Frame: 7 Days ]
    length of the longest tissue biopsy piece (centimeters) as measured by pathology



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103997


Locations
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United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Sponsors and Collaborators
Geisinger Clinic
Investigators
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Principal Investigator: David L Diehl, M.D. Geisinger Clinic
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Geisinger Clinic
ClinicalTrials.gov Identifier: NCT03103997    
Other Study ID Numbers: 2016-0300
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Geisinger Clinic:
Liver
EUS
Biopsy
Heparin
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases