Wet Heparin for Obtaining Liver Tissue for EUS Guided Liver Biopsy

• ClinicalTrials.gov Identifier: NCT03103997
• Recruitment Status: Completed
• First Posted: April 7, 2017
• Last Update Posted: August 23, 2018
• Sponsor: Geisinger Clinic
• Information provided by (Responsible Party): Geisinger Clinic

Study Description

Brief Summary:

Since its inception, endoscopic ultrasound with fine needle aspiration (EUS-FNA) has proven a valuable diagnostic and prognostic tool for evaluating a diverse number of pathologies. One such pathology is chronic liver disease (CLD), for which EUS-guided liver biopsy has become a well-accepted method for tissues acquisition. EUS-LB also been compared with percutaneous and transguluar routes showing at least comparable ability to obtain adequate tissue for CLD.

Though enhancements to EUS-FNA, such as dry suction, stylet pull have not proven to demonstrate increased diagnostic accuracy for EUS-FNA, the use of wet suction technique (WEST) has demonstrated the ability to obtain more cellular tissue samples with less blood contamination. In an attempt to obtain further improvement in tissue adequacy, with less blood contamination for EUS-LB, the use of wet heparinized needles will be investigated as compared with conventional EUS-LB for patients with CLD. To do this subjects shall be selected to undergo EUS-LB. As it is the standard to perform 3 needle passes during EUS-LB, subjects will undergo one pass with the following designations: pass 1: conventional EUS-LB [no flush], pass 2: dry heparin heparin [5 milliliters (mL) of heparin flushed and then flushed with air], and pass 3: wet heparin [5 milliliters (mL) of heparin flushed and retained in the needle]. It is predicted that specimens collected with heparinized needle shall show improved adequacy compared with conventional EUS-LB. It is also predicted that the heparin wash will lead to less blood contamination compared with conventional methods. Subjects shall also be monitored for adverse events (AE).

Condition or disease	Intervention/treatment	Phase
Liver Diseases	Procedure: EUS-guided liver biopsy	Not Applicable

Detailed Description:

3 BACKGROUND AND SIGNIFICANCE Since its inception in 1992, endoscopic ultrasound with fine needle aspiration (EUS-FNA) has continued to be an evolving method for obtaining diagnostically accuracy for gastrointestinal, and extra-luminal pathology. 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. However, this accuracy is dependent upon determination of adequacy by expert gastrointestinal pathologists, which may not be available at all centers.

To enhance the diagnostic accuracy of EUS-FNA, several techniques have been described including, acquisition of a core specimen by fine needle biopsy (FNB), the use of a stylet, and suction. Regarding FNB, this technique allows for acquisition of a tissue specimen with intact tissue architecture and therefore more ability for immunohistochemical staining (IHC). The original generations of FNB needles have been studies, demonstrating no noticeable advantage of convention FNA. More recent evolutions of these FNB needles have led to promising preliminary results. For obtaining EUS-guided liver biopsy (EUS-LB), the technical success was 100% and over 91% diagnostic accuracy. Furthermore, EUS-LB appears to have a higher diagnostic accuracy for chronic liver disease (CLD) compared with percutaneous (PLB) and transgulular (TLB) routes. Overall, EUS-FNB appears to be a promising additional to EUS guided tissue acquisition, which shall lead to improved diagnostic accuracy.

In addition to EUS-FNB, both EUS-FNA with stylet use and suction, have gained some notoriety. It is important to note that there is no definitive evidence of improved diagnostic accuracy of EUS-FNA with these methods. One caveat to these supplemental methods for EUS-FNA, would be the use of "wet suction" technique (WEST) for EUS-FNA. The wet suction technique involved the use of 5 milliliters (mL) of 0.9% normal saline (NS) to supplant the traditional column of air present in the FNA needle. When compared to traditional EUS-FNA, the WEST demonstrated an increase in cellularity of the cellblock, improved specimen accuracy and no difference in the blood contamination compared with standard EUS-FNA. Though not specifically an EUS technique, using heparinized needles for PLB of liver lesions, has been described as well. Despite these promising results, this technique has never been employed as an enhancement to EUS-FNA.

Therefore in this study a heparinized solution (wet heparin) shall be employed for the acquisition of tissue in EUS-LB compared with dry heparin and convention EUS-LB. It is predicted that EUS-LB wet heparin will lead to less blood contamination and more adequate tissue acquisition, as compared with dry heparin and conventional EUS-LB.

Primary End Points

1. Proportion of cases for which a histologic diagnosis could be made based upon the amount of tissue obtained with the needle.
2. Number of portal tracts (PT) in the specimen
3. Aggregate specimen length (ASL), length of the longest piece (LLP), and degree of fragmentation Secondary End Points

1. Presence of a visible core specimen 2. Presence of visible clots in specimen 3. Adverse events (AE) and serious adverse events (SAE) 4 HYPOTHESIS AND SPECIFIC AIMS 4.1 Hypothesis It is predicted that EUS-LB with wet heparin will lead to less blood contamination and more adequate tissue acquisition, as compared with dry heparin and conventional EUS-LB 4. 2 Specific Aim 1 To determine the adequacy of EUS-LB using wet and dry heparin 4.3 Specific Aim 2 To determine the degree of blood contamination for EUS-LB using wet heparin and dry heparin 4.4 Specific Aim 3 To determine the adequacy for EUS-LB using wet heparin and dry heparin 5 PRELIMINARY DATA Heparin flush has been used previously in several patients undergoing EUS-guided liver biopsy, and cores of liver tissue can be obtained. It has been found that this needle preparation using heparin flush has led to the presence of less blood contamination of tissue and therefore improved diagnostic accuracy and ability to make the diagnosis.

6 STUDY DESIGN 6.1 Description This is an open-labeled, prospective trial comparing tissue acquisition adequacy and blood contamination for EUS-LB using wet heparin (Group A), dry heparin (Group B) and conventional EUS-LB (Group C).

Group A: Needle flushed with 5mL of heparin, left in the EUS-FNB needle Group B: Needle flushed with 5mL of heparin, then flushed with air to dry Group C: Needle not flushed with solution

Subjects shall then undergo EUS-LB (see below) with 3 trans-gastric passes total in the left lobe, as is the present standard of practice. Pass 1: Group C, Pass 2: Group B, Pass 3: Group A.

After EUS-LB, the tissue sample shall then be evaluated after each pass by the endosongrapher performing EUS-LB for tissue length. The tissue and fluid washed from the tissue specimens shall then be sent for processing, as described below, and evaluated for the primary and secondary outcomes by 2 expert pathologists, blinded to which arm each specimen had come from. Patients shall then receive a telephone call 7 days after EUS-LB to evaluate for adverse events.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Subjects enrolled will undergo EUS-guided biopsies in the following manner. First pass needle out of package without preparation and full suction. Second pass: needle flushed with heparin, then flushed with air and suction, dry heparin. Third pass: needle flushed with heparin and then 2 cc of liquid added to suction syringe and attached, wet heparin.
• Masking: Single (Outcomes Assessor)
• Masking Description: Participants undergo each biopsy in the protocol. The care provider will be directing and performing each needle pass. The outcome assessor will be unaware of each group.
• Primary Purpose: Diagnostic
• Official Title: Wet Heparinized Suction: A Novel Technique to Enhance Tissue Acquisition for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB): A Prospective Trial
• Actual Study Start Date: January 6, 2017
• Actual Primary Completion Date: June 1, 2018
• Actual Study Completion Date: June 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: New Needle; EUS-guided liver biopsy with needle and suction, no preparation	Procedure: EUS-guided liver biopsy; EUS-guided liver biopsy using needles with various preparations
Experimental: Dry Heparin; EUS-guided liver biopsy with needle flushed with heparin, then flushed with air, suction then attached	Procedure: EUS-guided liver biopsy; EUS-guided liver biopsy using needles with various preparations
Experimental: Wet Heparin; EUS-guided liver biopsy with needle flushed with heparin, 2 cc of liquid added to suction then attached.	Procedure: EUS-guided liver biopsy; EUS-guided liver biopsy using needles with various preparations

Outcome Measures

Primary Outcome Measures :

1. Proportion of cases for which a histologic diagnosis could be made based upon Proportion of cases for which a histologic diagnosis could be made based upon the amount of tissue obtained with the needle [ Time Frame: 7 days ]
   Proportion of cases for which a histologic diagnosis could be made based upon the amount of tissue obtained with the needle

Secondary Outcome Measures :

1. The Number of patients with a visible core after needle biopsy [ Time Frame: Presence of a visible core specimen (yes/no) at time 7 days ]
   Day of Procedure
2. The Number of patients with a visible clot after needle biopsy [ Time Frame: Presence of visible clots in specimen (yes/no) at time 7 days ]
   Day of Procedure
3. The Number of patients with visible bleeding after needle biopsy [ Time Frame: 7 Days ]
   Patient with blood visible from patient's mouth, rectum with a 2 gram drop in hemoglobin
4. The Number of patients with Pain 1 Day after needle biopsy [ Time Frame: 1 Days ]
   Pain using Likert score 0-10 (10 worst)
5. The Number of patients with Pain 7 Day after needle biopsy [ Time Frame: 7 Days ]
   Pain using Likert score 0-10 (10 worst)
6. The Number of patients requiring medical care after needle biopsy [ Time Frame: 7 Days ]
   Patient requiring visit to healthcare center (emergency room, hospital, call to service) within time 7 days
7. Number of portal tracts (PT) in the specimen (total) under histologic examination [ Time Frame: 7 Days ]
   Number of portal tracts (PT) in the specimen (total) under histologic examination
8. Aggregate Specimen Length under histologic examination [ Time Frame: 7 Days ]
   Length of all the tissue (centimeters) by adding the sum of all pieces
9. Length of the longest piece under histologic examination [ Time Frame: 7 Days ]
   length of the longest tissue biopsy piece (centimeters) as measured by pathology

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Patients undergoing EUS-LB
2. Platelet count > 50,000
3. International normalized ratio (INR) < 1.5
4. Age > 18 years
5. Non-pregnant patients

Exclusion Criteria:

1. Age < 18 years
2. Pregnant Patients
3. Inability to obtain consent
4. Anticoagulants or anti-platelet agents use (excluding aspirin) within the last 7-10 days
5. Platelet count < 50,000
6. INR > 1.5
7. Presence of ascites
8. Known liver cirrhosis
9. Patients with a heparin or porcine allergy
10. Patients with prior heparin induced thrombocytopenia (HIT)
11. Patient's with religious aversion to porcine-containing products

Contacts and Locations

Locations

United States, Pennsylvania

Geisinger Medical Center

Danville, Pennsylvania, United States, 17822

Sponsors and Collaborators

Geisinger Clinic

Investigators

• Principal Investigator: David L Diehl, M.D.; Geisinger Clinic

More Information

Publications of Results:

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Stavropoulos SN, Im GY, Jlayer Z, Harris MD, Pitea TC, Turi GK, Malet PF, Friedel DM, Grendell JH. High yield of same-session EUS-guided liver biopsy by 19-gauge FNA needle in patients undergoing EUS to exclude biliary obstruction. Gastrointest Endosc. 2012 Feb;75(2):310-8. doi: 10.1016/j.gie.2011.09.043.

Gor N, Salem SB, Jakate S, Patel R, Shah N, Patil A. Histological adequacy of EUS-guided liver biopsy when using a 19-gauge non-Tru-Cut FNA needle. Gastrointest Endosc. 2014 Jan;79(1):170-2. doi: 10.1016/j.gie.2013.06.031. Epub 2013 Jul 31. No abstract available.

Diehl DL, Johal AS, Khara HS, Stavropoulos SN, Al-Haddad M, Ramesh J, Varadarajulu S, Aslanian H, Gordon SR, Shieh FK, Pineda-Bonilla JJ, Dunkelberger T, Gondim DD, Chen EZ. Endoscopic ultrasound-guided liver biopsy: a multicenter experience. Endosc Int Open. 2015 Jun;3(3):E210-5. doi: 10.1055/s-0034-1391412. Epub 2015 Feb 27.

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Pineda JJ, Diehl DL, Miao CL, Johal AS, Khara HS, Bhanushali A, Chen EZ. EUS-guided liver biopsy provides diagnostic samples comparable with those via the percutaneous or transjugular route. Gastrointest Endosc. 2016 Feb;83(2):360-5. doi: 10.1016/j.gie.2015.08.025. Epub 2015 Aug 22.

Wallace MB, Kennedy T, Durkalski V, Eloubeidi MA, Etamad R, Matsuda K, Lewin D, Van Velse A, Hennesey W, Hawes RH, Hoffman BJ. Randomized controlled trial of EUS-guided fine needle aspiration techniques for the detection of malignant lymphadenopathy. Gastrointest Endosc. 2001 Oct;54(4):441-7. doi: 10.1067/mge.2001.117764.

Sahai AV, Paquin SC, Gariepy G. A prospective comparison of endoscopic ultrasound-guided fine needle aspiration results obtained in the same lesion, with and without the needle stylet. Endoscopy. 2010 Nov;42(11):900-3. doi: 10.1055/s-0030-1255676. Epub 2010 Aug 19. Erratum In: Endoscopy. 2011 Feb;43(2):168.

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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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Bhatia V, Hijioka S, Hara K, Mizuno N, Imaoka H, Yamao K. Endoscopic ultrasound description of liver segmentation and anatomy. Dig Endosc. 2014 May;26(3):482-90. doi: 10.1111/den.12216. Epub 2013 Dec 19.

ASGE Standards of Practice Committee; Early DS, Acosta RD, Chandrasekhara V, Chathadi KV, Decker GA, Evans JA, Fanelli RD, Fisher DA, Fonkalsrud L, Hwang JH, Jue TL, Khashab MA, Lightdale JR, Muthusamy VR, Pasha SF, Saltzman JR, Sharaf RN, Shergill AK, Cash BD. Adverse events associated with EUS and EUS with FNA. Gastrointest Endosc. 2013 Jun;77(6):839-43. doi: 10.1016/j.gie.2013.02.018. No abstract available.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Geisinger Clinic
• ClinicalTrials.gov Identifier: NCT03103997
• Other Study ID Numbers: 2016-0300
• First Posted: April 7, 2017
• Last Update Posted: August 23, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Geisinger Clinic:

Liver; EUS; Biopsy; Heparin

Additional relevant MeSH terms:

Liver Diseases; Digestive System Diseases