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NCT03103997 · ClinicalTrials.gov registry record · NA

Wet Heparin for Obtaining Liver Tissue for EUS Guided Liver Biopsy

A NA study, sponsored by Geisinger Clinic.

Completed
Registry status
NA
Development phase
40
Enrollment target

NCT03103997 is a NA study that has completed, run by Geisinger Clinic. The registered enrollment target is 40 participants.

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The verdict

NCT03103997, a NA study, has completed, sponsored by Geisinger Clinic.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target

Study 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).

Interventions

  • PROCEDURE EUS-guided liver biopsy

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2017-01-06
Est. Completion 2018-06-30
Phase NA

Sponsor

Geisinger Clinic

107 total trials

What the Registry Record Tells You About NCT03103997

The ClinicalTrials.gov registry entry for NCT03103997 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Geisinger Clinic, which has 107 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which EUS-guided liver biopsy is the first listed.

NCT03103997 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03103997 about?

NCT03103997 is a clinical study titled "Wet Heparin for Obtaining Liver Tissue for EUS Guided Liver Biopsy". 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...

What is the current status of trial NCT03103997?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2017-01-06. Estimated completion is 2018-06-30.

What interventions are being tested in trial NCT03103997?

The interventions under investigation include: EUS-guided liver biopsy (PROCEDURE).

Who is sponsoring clinical trial NCT03103997?

This trial is sponsored by Geisinger Clinic, which has 107 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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