Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
42 participants
Study Classification
INTERVENTIONAL
Study Start Date
2026-03-15
Study Completion Date
2027-01-12
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.
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.
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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.
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.
Conditions
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Cancer of Pancreas
Cancer of Stomach
Cancer of Esophagus
Cancer of Liver
Cancer
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
DIAGNOSTIC
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
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.
Study Groups
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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
Group Type
EXPERIMENTAL
wet heparinzed suction
Intervention Type
OTHER
Needle flushed with 5000 Units in 10mL of heparin
Microsieve
Intervention Type
OTHER
A microsieve used for tissue preparation
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
Group Type
EXPERIMENTAL
wet heparinzed suction
Intervention Type
OTHER
Needle flushed with 5000 Units in 10mL of heparin
No microsieve
Intervention Type
OTHER
The tissue is placed into formalin
No heparin and microsieve
The needle not be prepped. The provider will expel the tissue onto the microsieve
Group Type
EXPERIMENTAL
Microsieve
Intervention Type
OTHER
A microsieve used for tissue preparation
No heparin flush
Intervention Type
OTHER
The needle not prepped
No heparina nd no microsieve
The needle not be prepped. The provider will expel the tissue into formalin
Group Type
ACTIVE_COMPARATOR
No heparin flush
Intervention Type
OTHER
The needle not prepped
No microsieve
Intervention Type
OTHER
The tissue is placed into formalin
Interventions
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wet heparinzed suction
Needle flushed with 5000 Units in 10mL of heparin
Intervention Type
OTHER
Microsieve
A microsieve used for tissue preparation
Intervention Type
OTHER
No heparin flush
The needle not prepped
Intervention Type
OTHER
No microsieve
The tissue is placed into formalin
Intervention Type
OTHER
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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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H. Lee Moffitt Cancer Center and Research Institute
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Shaffer Mok, MD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Locations
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Moffitt Cancer Center
Tampa, Florida, United States
Site Status
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Vilmann P, Jacobsen GK, Henriksen FW, Hancke S. Endoscopic ultrasonography with guided fine needle aspiration biopsy in pancreatic disease. Gastrointest Endosc. 1992 Mar-Apr;38(2):172-3. doi: 10.1016/s0016-5107(92)70385-x. No abstract available.
Reference Type
BACKGROUND
Dumonceau JM, Deprez PH, Jenssen C, Iglesias-Garcia J, Larghi A, Vanbiervliet G, Aithal GP, Arcidiacono PG, Bastos P, Carrara S, Czako L, Fernandez-Esparrach G, Fockens P, Gines A, Havre RF, Hassan C, Vilmann P, van Hooft JE, Polkowski M. Indications, results, and clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated January 2017. Endoscopy. 2017 Jul;49(7):695-714. doi: 10.1055/s-0043-109021. Epub 2017 May 16.
Reference Type
BACKGROUND
Hebert-Magee S, Bae S, Varadarajulu S, Ramesh J, Frost AR, Eloubeidi MA, Eltoum IA. The presence of a cytopathologist increases the diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration cytology for pancreatic adenocarcinoma: a meta-analysis. Cytopathology. 2013 Jun;24(3):159-71. doi: 10.1111/cyt.12071.
Reference Type
BACKGROUND
Iglesias-Garcia J, Dominguez-Munoz JE, Abdulkader I, Larino-Noia J, Eugenyeva E, Lozano-Leon A, Forteza-Vila J. Influence of on-site cytopathology evaluation on the diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of solid pancreatic masses. Am J Gastroenterol. 2011 Sep;106(9):1705-10. doi: 10.1038/ajg.2011.119. Epub 2011 Apr 12.
Reference Type
BACKGROUND
Eloubeidi MA, Tamhane A, Jhala N, Chhieng D, Jhala D, Crowe DR, Eltoum IA. Agreement between rapid onsite and final cytologic interpretations of EUS-guided FNA specimens: implications for the endosonographer and patient management. Am J Gastroenterol. 2006 Dec;101(12):2841-7. doi: 10.1111/j.1572-0241.2006.00852.x. Epub 2006 Oct 6.
Reference Type
BACKGROUND
Jhala NC, Jhala DN, Chhieng DC, Eloubeidi MA, Eltoum IA. Endoscopic ultrasound-guided fine-needle aspiration. A cytopathologist's perspective. Am J Clin Pathol. 2003 Sep;120(3):351-67. doi: 10.1309/MFRF-J0XY-JLN8-NVDP.
Reference Type
BACKGROUND
Itoi T, Itokawa F, Sofuni A, Nakamura K, Tsuchida A, Yamao K, Kawai T, Moriyasu F. Puncture of solid pancreatic tumors guided by endoscopic ultrasonography: a pilot study series comparing Trucut and 19-gauge and 22-gauge aspiration needles. Endoscopy. 2005 Apr;37(4):362-6. doi: 10.1055/s-2004-826156.
Reference Type
BACKGROUND
Larghi A, Capurso G, Carnuccio A, Ricci R, Alfieri S, Galasso D, Lugli F, Bianchi A, Panzuto F, De Marinis L, Falconi M, Delle Fave G, Doglietto GB, Costamagna G, Rindi G. Ki-67 grading of nonfunctioning pancreatic neuroendocrine tumors on histologic samples obtained by EUS-guided fine-needle tissue acquisition: a prospective study. Gastrointest Endosc. 2012 Sep;76(3):570-7. doi: 10.1016/j.gie.2012.04.477.
Reference Type
BACKGROUND
Iwashita T, Yasuda I, Doi S, Ando N, Nakashima M, Adachi S, Hirose Y, Mukai T, Iwata K, Tomita E, Itoi T, Moriwaki H. Use of samples from endoscopic ultrasound-guided 19-gauge fine-needle aspiration in diagnosis of autoimmune pancreatitis. Clin Gastroenterol Hepatol. 2012 Mar;10(3):316-22. doi: 10.1016/j.cgh.2011.09.032. Epub 2011 Oct 20.
Reference Type
BACKGROUND
Diehl DL, Mok SRS, Khara HS, Johal AS, Kirchner HL, Lin F. Heparin priming of EUS-FNA needles does not adversely affect tissue cytology or immunohistochemical staining. Endosc Int Open. 2018 Mar;6(3):E356-E362. doi: 10.1055/s-0043-121880. Epub 2018 Mar 7.
Reference Type
BACKGROUND
Kasugai H, Yamamoto R, Tatsuta M, Okano Y, Okuda S, Kishigami Y, Kitamura T, Wada A, Tamura H. Value of heparinized fine-needle aspiration biopsy in liver malignancy. AJR Am J Roentgenol. 1985 Feb;144(2):243-4. doi: 10.2214/ajr.144.2.243.
Reference Type
BACKGROUND
Mok SRS, Diehl DL, Johal AS, Khara HS, Confer BD, Mudireddy PR, Kirchner HL, Chen ZE. A prospective pilot comparison of wet and dry heparinized suction for EUS-guided liver biopsy (with videos). Gastrointest Endosc. 2018 Dec;88(6):919-925. doi: 10.1016/j.gie.2018.07.036. Epub 2018 Aug 16.
Reference Type
BACKGROUND
Attam R, Arain MA, Bloechl SJ, Trikudanathan G, Munigala S, Bakman Y, Singh M, Wallace T, Henderson JB, Catalano MF, Guda NM. "Wet suction technique (WEST)": a novel way to enhance the quality of EUS-FNA aspirate. Results of a prospective, single-blind, randomized, controlled trial using a 22-gauge needle for EUS-FNA of solid lesions. Gastrointest Endosc. 2015;81(6):1401-7. doi: 10.1016/j.gie.2014.11.023. Epub 2015 Feb 27.
Reference Type
BACKGROUND
Schulman AR, Thompson CC, Odze R, Chan WW, Ryou M. Optimizing EUS-guided liver biopsy sampling: comprehensive assessment of needle types and tissue acquisition techniques. Gastrointest Endosc. 2017 Feb;85(2):419-426. doi: 10.1016/j.gie.2016.07.065. Epub 2016 Aug 13.
Reference Type
BACKGROUND
Thomas T, Kaye PV, Ragunath K, Aithal G. Efficacy, safety, and predictive factors for a positive yield of EUS-guided Trucut biopsy: a large tertiary referral center experience. Am J Gastroenterol. 2009 Mar;104(3):584-91. doi: 10.1038/ajg.2008.97. Epub 2009 Feb 10.
Reference Type
BACKGROUND
Wahnschaffe U, Ullrich R, Mayerle J, Lerch MM, Zeitz M, Faiss S. EUS-guided Trucut needle biopsies as first-line diagnostic method for patients with intestinal or extraintestinal mass lesions. Surg Endosc. 2009 Oct;23(10):2351-5. doi: 10.1007/s00464-009-0345-2. Epub 2009 Mar 5.
Reference Type
BACKGROUND
Sey MS, Al-Haddad M, Imperiale TF, McGreevy K, Lin J, DeWitt JM. EUS-guided liver biopsy for parenchymal disease: a comparison of diagnostic yield between two core biopsy needles. Gastrointest Endosc. 2016 Feb;83(2):347-52. doi: 10.1016/j.gie.2015.08.012. Epub 2015 Aug 13.
Reference Type
BACKGROUND
Gleeson FC, Clayton AC, Zhang L, Clain JE, Gores GJ, Rajan E, Smyrk TC, Topazian MD, Wang KK, Wiersema MJ, Levy MJ. Adequacy of endoscopic ultrasound core needle biopsy specimen of nonmalignant hepatic parenchymal disease. Clin Gastroenterol Hepatol. 2008 Dec;6(12):1437-40. doi: 10.1016/j.cgh.2008.07.015. Epub 2008 Jul 26.
Reference Type
BACKGROUND
Nieto J, Khaleel H, Challita Y, Jimenez M, Baron TH, Walters L, Hathaway K, Patel K, Lankarani A, Herman M, Holloman D, Saab S. EUS-guided fine-needle core liver biopsy sampling using a novel 19-gauge needle with modified 1-pass, 1 actuation wet suction technique. Gastrointest Endosc. 2018 Feb;87(2):469-475. doi: 10.1016/j.gie.2017.05.013. Epub 2017 May 24.
Reference Type
BACKGROUND
Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
Reference Type
BACKGROUND
Burlingame OO, Kesse KO, Silverman SG, Cibas ES. On-site adequacy evaluations performed by cytotechnologists: correlation with final interpretations of 5241 image-guided fine-needle aspiration biopsies. Cancer Cytopathol. 2012 Jun 25;120(3):177-84. doi: 10.1002/cncy.20184. Epub 2011 Aug 31.
Reference Type
BACKGROUND
Mok SRS, Diehl DL, Johal AS, Khara HS, Confer BD, Mudireddy PR, Kovach AH, Diehl MM, Kirchner HL, Chen ZE. Endoscopic ultrasound-guided biopsy in chronic liver disease: a randomized comparison of 19-G FNA and 22-G FNB needles. Endosc Int Open. 2019 Jan;7(1):E62-E71. doi: 10.1055/a-0655-7462. Epub 2019 Jan 4.
Reference Type
BACKGROUND
Mok SRS, Diehl DL. The Role of EUS in Liver Biopsy. Curr Gastroenterol Rep. 2019 Jan 31;21(2):6. doi: 10.1007/s11894-019-0675-8.
Reference Type
BACKGROUND
Other Identifiers
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MCC-21926
Identifier Type: -
Identifier Source: org_study_id
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