CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
EUS-guided liver biopsyprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03103997
NCT03103997N/ACompleted

Wet Heparinized Suction: A Novel Technique to Enhance Tissue Acquisition for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB): A Prospective Trial

Geisinger Clinic·interventional·Posted Apr 7, 2017·Updated Aug 23, 2018

In Brief

A clinical study evaluating EUS-guided liver biopsy for Liver Diseases. Completed, enrolled 40 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Diseases
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 7, 2017
Enrollment StartJan 6, 2017
Primary CompletionJun 1, 2018
Study CompletionJun 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.2 years ago

Interventions

EUS-guided liver biopsyprocedure

EUS-guided liver biopsy using needles with various preparations