Wet Heparinized Suction for Abdominal Cancer

Cancer Clinical Trial

— EUS Heparin  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05041335
• Other study ID #: MCC-21926
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: December 12, 2024

Study information

• Verified date: May 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Shaffer Mok, MD
• Phone: 6099804564
• Email: mok.shaffer[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: December 12, 2024
• Est. primary completion date: December 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Cancer of Esophagus
• Cancer of Liver
• Cancer of Pancreas
• Cancer of Stomach
• Esophageal Neoplasms
• Liver Neoplasms
• Pancreatic Neoplasms
• Stomach Neoplasms

Intervention

Other:
• wet heparinzed suction
Needle flushed with 5000 Units in 10mL of heparin
• Microsieve
A microsieve used for tissue preparation
• No heparin flush
The needle not prepped
• No microsieve
The tissue is placed into formalin

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (23)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Gastrointest Endosc. 2012 Nov;76(5):1085. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aggregate specimen length (ASL)	sum length of all pieces of tissue obtained from EUS-FNB	immediately after the intervention/procedure/surgery
Secondary	Length of the longest piece (LLP)	total length of the longest tissue piece	immediately after the intervention/procedure/surgery
Secondary	Mean number of small pieces	defined by pieces measuring <4 mm in length	immediately after the intervention/procedure/surgery
Secondary	Mean number of medium pieces	defined by pieces measuring 5-8 mm in length	immediately after the intervention/procedure/surgery
Secondary	Means number of long pieces	defined by pieces measuring >9 mm in length	immediately after the intervention/procedure/surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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