EUS Heparin: Wet Heparinized Suction for Abdominal Cancer

Sponsor

H. Lee Moffitt Cancer Center and Research Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05041335

Collaborator

(none)

Enrollment

Location

Arms

11.9

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer of Pancreas Cancer of Stomach Cancer of Esophagus Cancer of Liver Cancer	Other: wet heparinzed suction Other: Microsieve Other: No heparin flush Other: No microsieve	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Participant, Care Provider, Investigator)

Masking Description:

These needle preparations will be wrapped in non-transparent 2-inch tape to hide the appearance of the injectate agent. The needle is prepared by removing the stylet and flushing with the selected substance. The PI/Co-I will then flush the needle with the selected substance until drops of the liquid are seen exiting the needle tip. Those randomized to have the needle flushed with heparin will be termed "dry heparin" and will be flushed with 500 U heparin USP per 10 mL. Those who randomize not to receive heparin, the needle will be flushed with saline. The device shall then be placed into the linear echoendoscope and the FNB will be performed. The PI is blinded to heparin vs. no heparin only. Randomization to the microsieve vs. not is apparent to the PI.

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Dec 15, 2022

Anticipated Primary Completion Date :

Dec 12, 2023

Anticipated Study Completion Date :

Dec 12, 2023

Arms and Interventions

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 heparin flush The needle not prepped Other: No microsieve The tissue is placed into formalin

Outcome Measures

Primary Outcome Measures

Aggregate specimen length (ASL) [immediately after the intervention/procedure/surgery]
sum length of all pieces of tissue obtained from EUS-FNB

Secondary Outcome Measures

Length of the longest piece (LLP) [immediately after the intervention/procedure/surgery]
total length of the longest tissue piece
Mean number of small pieces [immediately after the intervention/procedure/surgery]
defined by pieces measuring <4 mm in length
Mean number of medium pieces [immediately after the intervention/procedure/surgery]
defined by pieces measuring 5-8 mm in length
Means number of long pieces [immediately after the intervention/procedure/surgery]
defined by pieces measuring >9 mm in length
Histology adequacy score [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
Presence of a visible core specimen [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
Presence of visible clots in specimen [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
Mean blood clot score during histology [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).
Adequacy of diagnosis [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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