Cancer of PancreasEUS HeparinNCT05041335
Wet Heparinized Suction for Abdominal Cancer
A study testing wet heparinzed suction, Microsieve and No heparin flush in people with Cancer of Pancreas and Cancer of Stomach, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer of Pancreas, Cancer of Stomach, Cancer of Esophagus
- What is being tested?
- wet heparinzed suction, Microsieve and No heparin flush
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2025to 25 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- wet heparinzed suction, Microsieve, No heparin flush, No microsieve
- Keywords
- cancer, esophagus, stomach, gastric, pancreas, biliary, bile, bile duct, liver, hepatic
- Medical subject headings
- Pancreatic Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Liver Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wet heparinzed suctionOther
Needle flushed with 5000 Units in 10mL of heparin
MicrosieveOther
A microsieve used for tissue preparation
No heparin flushOther
The needle not prepped
No microsieveOther
The tissue is placed into formalin
| Study group | Role | What they receive |
|---|---|---|
| Heparin and microsieve | Experimental | 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 Receives: Other: wet heparinzed suction; Other: Microsieve |
| Heparin and no microsieve | Experimental | 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 Receives: Other: wet heparinzed suction; Other: No microsieve |
| No heparin and microsieve | Experimental | The needle not be prepped. The provider will expel the tissue onto the microsieve Receives: Other: Microsieve; Other: No heparin flush |
| No heparina nd no microsieve | Active comparator | The needle not be prepped. The provider will expel the tissue into formalin Receives: Other: No heparin flush; Other: No microsieve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aggregate specimen length (ASL)
sum length of all pieces of tissue obtained from EUS-FNB
Measured: immediately after the intervention/procedure/surgery
Secondary outcomes (9)
Length of the longest piece (LLP)
total length of the longest tissue piece
Measured: immediately after the intervention/procedure/surgery
Mean number of small pieces
defined by pieces measuring <4 mm in length
Measured: immediately after the intervention/procedure/surgery
Mean number of medium pieces
defined by pieces measuring 5-8 mm in length
Measured: immediately after the intervention/procedure/surgery
Means number of long pieces
defined by pieces measuring >9 mm in length
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: immediately after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start25 Nov 2025 (estimated)
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
Why it stopped: study no longer proceeding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Cancer of PancreasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaffer Mok, MD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041335
- Sponsor's protocol ID
- MCC-21926
- Acronym
- EUS Heparin
- Status last verified
- Sep 2026
- First submitted
- 15 Feb 2021
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 1568614Dumonceau 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.
PubMed 28511234Hebert-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.
PubMed 23711182Iglesias-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.
PubMed 21483464Eloubeidi 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.
PubMed 17026562Jhala 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.
PubMed 14502798Itoi 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.
PubMed 15824948Larghi 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.
PubMed 22898415Iwashita 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.
PubMed 22019795Diehl 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.
PubMed 29527558Kasugai 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.
PubMed 2981458Mok 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.
PubMed 30120956Attam 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.
PubMed 25733127Schulman 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.
PubMed 27530070Thomas 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.
PubMed 19262518
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05041335
- Acronym / sponsor ID
- EUS Heparin / MCC-21926
- Keywords
- cancer, esophagus, stomach, gastric, pancreas, biliary, bile, bile duct
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study no longer proceeding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 25 Nov 2025 (estimated)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Heparin and microsieve | Experimental | Other: wet heparinzed suction, Other: MicrosieveThe 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 |
| Heparin and no microsieve | Experimental | Other: wet heparinzed suction, Other: No microsieveThe 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 |
| No heparin and microsieve | Experimental | Other: Microsieve, Other: No heparin flushThe needle not be prepped. The provider will expel the tissue onto the microsieve |
| No heparina nd no microsieve | Active comparator | Other: No heparin flush, Other: No microsieveThe needle not be prepped. The provider will expel the tissue into formalin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wet heparinzed suctionNeedle flushed with 5000 Units in 10mL of heparin | Other | Heparin and microsieve, Heparin and no microsieve |
| MicrosieveA microsieve used for tissue preparation | Other | Heparin and microsieve, No heparin and microsieve |
| No heparin flushThe needle not prepped | Other | No heparin and microsieve, No heparina nd no microsieve |
| No microsieveThe tissue is placed into formalin | Other | Heparin and no microsieve, No heparina nd no microsieve |
Primary outcome
Aggregate specimen length (ASL)
Time frame: immediately after the intervention/procedure/surgery
sum length of all pieces of tissue obtained from EUS-FNB
9 secondary outcomes
Length of the longest piece (LLP)
Time frame: immediately after the intervention/procedure/surgery
Mean number of small pieces
Time frame: immediately after the intervention/procedure/surgery
Mean number of medium pieces
Time frame: immediately after the intervention/procedure/surgery
Means number of long pieces
Time frame: immediately after the intervention/procedure/surgery
Histology adequacy score
Time frame: immediately after the intervention/procedure/surgery
Presence of a visible core specimen
Time frame: immediately after the intervention/procedure/surgery
Presence of visible clots in specimen
Time frame: immediately after the intervention/procedure/surgery
Mean blood clot score during histology
Time frame: immediately after the intervention/procedure/surgery
Adequacy of diagnosis
Time frame: immediately after the intervention/procedure/surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 1568614Vilmann 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.
- Background: PubMed 28511234Dumonceau 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.
- Background: PubMed 23711182Hebert-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.
- Background: PubMed 21483464Iglesias-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.
- Background: PubMed 17026562Eloubeidi 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.
- Background: PubMed 14502798Jhala 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.
- Background: PubMed 15824948Itoi 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.
- Background: PubMed 22898415Larghi 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.
- Background: PubMed 22019795Iwashita 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.
- Background: PubMed 29527558Diehl 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.
- Background: PubMed 2981458Kasugai 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.
- Background: PubMed 30120956Mok 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaffer Mok, MD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wet heparinzed suction, Microsieve and No heparin flush in people with Cancer of Pancreas and Cancer of Stomach, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aggregate specimen length (ASL) (time frame: immediately after the intervention/procedure/surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05041335, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.