Wet Heparinized Suction for Abdominal Cancer (EUS Heparin)

April 21, 2025 updated by: H. Lee Moffitt Cancer Center and Research Institute

Wet Heparinized Suction: A Novel Technique to Enhance Tissue Acquisition for Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB) of Solid Abdominal Masses: A Randomized Prospective Trial

The purpose of this research is to compare the amount and quality of tissue obtained by EUS-FNB when the device is flushed with an anticoagulant or "blood thinner" vs. saline a salt water solution as well as the use of a microsieve in order for the doctor to look at the tissue to check the acceptability of the specimens before sending for analysis.

You will be randomly assigned (like a flip of a coin) to have either the blood thinner or the salt water solution placed within the needle being used to sample your abdominal tumor and to have either a sieve used or not.

You will be one of 42 participants enrolled in this data collection study which includes 1 sites in the United States.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Since its inception in the early 1990's, endoscopic ultrasound with fine needle aspiration (EUS-FNA) has developed into an important method for obtaining diagnostically accuracy for gastrointestinal, and extra-luminal pathology [1,2]. Present society guidelines by both the European Society of Gastrointestinal Endoscopy (ESGE) and American Society of Gastrointestinal Endoscopy (ASGE) have estimated an overall 60-90% diagnostic accuracy of EUS-FNA [2,3]. However, this accuracy is dependent upon determination of adequacy by expert gastrointestinal pathologists, which may not be available at all centers [4-6].

New developments in needle technology has led to development of "core needles", which can allow for acquisition of a tissue specimen with intact tissue architecture and therefore more ability for immunohistochemical staining (IHC). When evaluating pancreatic lesions, FNB needles have demonstrated 81-100% technical success and up to 94.7% diagnostic accuracy [18-21]. Overall, EUS-FNB appears to be a promising addition to EUS guided tissue acquisition, which has the potential of leading to improved diagnostic accuracy.

As an additional means for optimizing EUS-FNB, heparin has been described and studied in the past. The study investigators have been using heparin to prime the wet suction needle to prevent formation of clot in the needle which produces "blood noodles" in the specimen that can interfere with tissue processing and interpretation. There are previous data demonstrating that heparin priming of the needle may also increase yield [22]. The study investigators have demonstrated that use of a heparin primed needle does not interfere with cytology, histology or immunohistochemical analysis, and may ease stylet handling [23]. Also, the study investigators have directly validated the use of heparin for EUS-guided liver biopsies (EUS-LB) demonstrating improvement in the size and number of histologic fragments obtained from EUS-guided biopsy [24-25]. Given this information, heparin flush is actively used and readily available, in EUS-guided biopsies here at UH.

Rapid onsite cytological evaluation (ROSE) has been used to make an immediate assessment of tissue adequacy during the EUS-FNA procedure, as well as to deliver a rapid pathological diagnosis during the EUS session. ROSE has been shown to increase the yield while having the potential of decreasing the number of needle passes required. However, ROSE is not available at many EUS centers. It would be advantageous to predict adequacy of a needle biopsy specimen without having to rely on ROSE.

In standard EUS-FNA practice, part of the biopsy specimens is used to prepare a smear that can be examined microscopically. The remainder of the specimen processed by the laboratory for "cell block" analysis. Microscopic examination of the smears and the cell-block are done by the pathologist to arrive at a final diagnosis.

The study investigators have developed a new technique of specimen enrichment using a "microsieve device". In this technique, a small microsieve collects the larger tissue fragments, while single cells and small cell clusters wash through the microsieve. Visible tissue fragments or cores likely represent a macroscopic representation of adequacy of tissue, and could theoretically supplant ROSE in providing an on-site determination of adequacy.

In the course of this study, the study investigators will collect the larger fragments as well as the wash-through and examine each separately.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age ≥ 18 year
  • Non-pregnant Patients
  • Patients with the presence of a solid abdominal mass as seen on diagnostic imaging [ie. ultrasound (US), computer tomography (CT) or magnetic resonance imaging (MRI)] scheduled to undergo EUS examination OR Patients who underwent a prior EUS-FNA/FNB for solid pancreatic mass and did not receive a conclusive diagnosis
  • Patients with platelet count > 50,000
  • Patients with International Normalized Ratio (INR) < 1.5

Exclusion Criteria:

  • Age < 18 years
  • Pregnant Patients
  • Patients who cannot consent for themselves
  • Patients with anticoagulants or anti-platelet agents (excluding aspirin) within the last 7-10 days
  • Patients with cystic abdominal masses
  • Patients with a platelet count < 50,000
  • Patients with an INR > 1.5
  • Patients with a heparin or porcine allergy
  • Patients with prior heparin induced thrombocytopenia (HIT)
  • Patient's with religious aversion to porcine-containing products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heparin and microsieve
The needle will be prepped with 500 U heparin USP per 10 mL to coat the inside of the needle. The provider will expel the tissue onto the microsieve
Other: wet heparinzed suction
Needle flushed with 5000 Units in 10mL of heparin
Other: Microsieve
A microsieve used for tissue preparation
Experimental: Heparin and no microsieve
The needle will be prepped with 500 U heparin USP per 10 mL to coat the inside of the needle. The provider will expel the tissue into formalin
Other: wet heparinzed suction
Needle flushed with 5000 Units in 10mL of heparin
Other: No microsieve
The tissue is placed into formalin
Experimental: No heparin and microsieve
The needle not be prepped. The provider will expel the tissue onto the microsieve
Other: Microsieve
A microsieve used for tissue preparation
Other: No heparin flush
The needle not prepped
Active Comparator: No heparina nd no microsieve
The needle not be prepped. The provider will expel the tissue into formalin
Other: No microsieve
The tissue is placed into formalin
Other: No heparin flush
The needle not prepped

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aggregate specimen length (ASL)
Time Frame: immediately after the intervention/procedure/surgery
sum length of all pieces of tissue obtained from EUS-FNB
immediately after the intervention/procedure/surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of the longest piece (LLP)
Time Frame: immediately after the intervention/procedure/surgery
total length of the longest tissue piece
immediately after the intervention/procedure/surgery
Mean number of small pieces
Time Frame: immediately after the intervention/procedure/surgery
defined by pieces measuring <4 mm in length
immediately after the intervention/procedure/surgery
Mean number of medium pieces
Time Frame: immediately after the intervention/procedure/surgery
defined by pieces measuring 5-8 mm in length
immediately after the intervention/procedure/surgery
Means number of long pieces
Time Frame: immediately after the intervention/procedure/surgery
defined by pieces measuring >9 mm in length
immediately after the intervention/procedure/surgery
Histology adequacy score
Time Frame: immediately after the intervention/procedure/surgery
Histology adequacy score, defined as 1, a pathologist can make a clinical diagnosis using the tissue obtained or 0 a pathologist cannot make a clinical diagnosis using the tissue obtained
immediately after the intervention/procedure/surgery
Presence of a visible core specimen
Time Frame: immediately after the intervention/procedure/surgery
defined as 1, visible tissue seen by the endoscopist at the time of tissue preparation or 0 no visible tissue seen by the endoscopist at the time of tissue preparation
immediately after the intervention/procedure/surgery
Presence of visible clots in specimen
Time Frame: immediately after the intervention/procedure/surgery
defined as 1, visible clots seen by the endoscopist at the time of tissue preparation or 0 visible clots seen by the endoscopist at the time of tissue preparation
immediately after the intervention/procedure/surgery
Mean blood clot score during histology
Time Frame: immediately after the intervention/procedure/surgery
Defined as (0: Nearly absent of red blood cells (RBC), 1+: Monolayer of RBC, no cluster formation, 2+: Aggregates of RBC present, < x40 high power field, 3+: Aggregates of RBC present, > x40 high power field).
immediately after the intervention/procedure/surgery
Adequacy of diagnosis
Time Frame: immediately after the intervention/procedure/surgery
based upon fluid washed out from the microsieve tissue sample defined by Smears with relatively abundant and well-visualized lesional material.
immediately after the intervention/procedure/surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Shaffer Mok, MD, Moffitt Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

January 12, 2027

Study Completion (Estimated)

January 12, 2027

Study Registration Dates

First Submitted

February 15, 2021

First Submitted That Met QC Criteria

September 7, 2021

First Posted (Actual)

September 13, 2021

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 21, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-21926

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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