Wet Heparinized Suction for Abdominal Cancer

NCT05041335 | Not Yet Recruiting DMC

• 1 other identifier: MCC-21926
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Pancreas; Cancer of Stomach; Cancer of Esophagus; Cancer of Liver; Cancer

Keywords

cancer; esophagus; stomach; gastric; pancreas; biliary; bile; bile duct; liver; hepatic

Outcome Measures

Primary Outcomes (1)

• Aggregate specimen length (ASL)

  sum length of all pieces of tissue obtained from EUS-FNB

  immediately after the intervention/procedure/surgery

Secondary Outcomes (9)

• Length of the longest piece (LLP)

  immediately after the intervention/procedure/surgery

• Mean number of small pieces

  immediately after the intervention/procedure/surgery

• Mean number of medium pieces

  immediately after the intervention/procedure/surgery

• Means number of long pieces

  immediately after the intervention/procedure/surgery

• Histology adequacy score

  immediately after the intervention/procedure/surgery

Study Arms (4)

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

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

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

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

Other: No heparin flush; Other: No microsieve

Interventions

wet heparinzed suction OTHER

Needle flushed with 5000 Units in 10mL of heparin

Heparin and microsieve; Heparin and no microsieve

Microsieve OTHER

A microsieve used for tissue preparation

Heparin and microsieve; No heparin and microsieve

No heparin flush OTHER

The needle not prepped

No heparin and microsieve; No heparina nd no microsieve

No microsieve OTHER

The tissue is placed into formalin

Heparin and no microsieve; No heparina nd no microsieve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Publications (23)

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• 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.

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• 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.

  PMID: 15824948 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.

  PMID: 22898415 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.

  PMID: 22019795 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.

  PMID: 29527558 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.

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• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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MeSH Terms

Conditions

Pancreatic Neoplasms; Stomach Neoplasms; Esophageal Neoplasms; Liver Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Liver Diseases

Study Officials

• Shaffer Mok, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shaffer Mok, MD

CONTACT

6099804564; mok.shaffer@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: September 13, 2021
• Study Start: March 15, 2026
• Primary Completion (Estimated): January 12, 2027
• Study Completion (Estimated): January 12, 2027
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)