Wet Heparinized Suction for Abdominal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Cancer of Pancreas, Cancer of Stomach, Cancer of Esophagus, Cancer of Liver, Cancer

Intervention / Treatment
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* Other: wet heparinzed suction
* Other: Microsieve
* Other: No heparin flush
* Other: No microsieve


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The control group will have 21 patients and the group receiving heparin will have 21 patients; the randomization is 1:1:1:1; heparin and microsieve, heparin and no microsieve, no heparin and microsieve and no heparin and no microsieve. Forty two subjects will be enrolled at UH for a total of 42 subjects.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heparin and microsieve<br>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<br>* Needle flushed with 5000 Units in 10mL of heparin<br>Other: Microsieve<br>* A microsieve used for tissue preparation<br>|
| Experimental: Heparin and no microsieve<br>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<br>* Needle flushed with 5000 Units in 10mL of heparin<br>Other: No microsieve<br>* The tissue is placed into formalin<br>|
| Experimental: No heparin and microsieve<br>The needle not be prepped. The provider will expel the tissue onto the microsieve | Other: Microsieve<br>* A microsieve used for tissue preparation<br>Other: No heparin flush<br>* The needle not prepped<br>|
| Active Comparator: No heparina nd no microsieve<br>The needle not be prepped. The provider will expel the tissue into formalin | Other: No heparin flush<br>* The needle not prepped<br>Other: No microsieve<br>* The tissue is placed into formalin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aggregate specimen length (ASL) | 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) | total length of the longest tissue piece | immediately after the intervention/procedure/surgery | 
| Mean number of small pieces | defined by pieces measuring <4 mm in length | immediately after the intervention/procedure/surgery | 
| Mean number of medium pieces | defined by pieces measuring 5-8 mm in length | immediately after the intervention/procedure/surgery | 
| Means number of long pieces | defined by pieces measuring >9 mm in length | immediately after the intervention/procedure/surgery | 
| Histology adequacy score | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, esophagus, stomach, gastric, pancreas, biliary, bile, bile duct, liver, hepatic