Liver DiseasesNCT03103997
Wet Heparin for Obtaining Liver Tissue for EUS Guided Liver Biopsy
A study testing EUS-guided liver biopsy in people with Liver Diseases, run by Geisinger Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases
- What is being tested?
- EUS-guided liver biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2017to 30 Jun 2018
- 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
- Patients undergoing EUS-LB
- Platelet count > 50,000
- International normalized ratio (INR) < 1.5
- Age > 18 years
- Non-pregnant patients
Who cannot join
- Age < 18 years
- Pregnant Patients
- Inability to obtain consent
- Anticoagulants or anti-platelet agents use (excluding aspirin) within the last 7-10 days
- Platelet count < 50,000
- INR > 1.5
Show all 11Show fewer
- Presence of ascites
- Known liver cirrhosis
- 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.
United States1 site
Geisinger Medical Center
Danville, Pennsylvania, 17822
About this study
Official title: Wet Heparinized Suction: A Novel Technique to Enhance Tissue Acquisition for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB): A Prospective Trial
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).
Read the 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
- Proportion of cases for which a histologic diagnosis could be made based upon the amount of tissue obtained with the needle.
- Number of portal tracts (PT) in the specimen
- Aggregate specimen length (ASL), length of the longest piece (LLP), and degree of fragmentation Secondary End Points
- 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.
- Conditions
- Liver Diseases
- Being tested
- EUS-guided liver biopsy
- Keywords
- Liver, EUS, Biopsy, Heparin
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-guided liver biopsyProcedure or surgery
EUS-guided liver biopsy using needles with various preparations
| Study group | Role | What they receive |
|---|---|---|
| New Needle | Active comparator | EUS-guided liver biopsy with needle and suction, no preparation Receives: Procedure: EUS-guided liver biopsy |
| Dry Heparin | Experimental | EUS-guided liver biopsy with needle flushed with heparin, then flushed with air, suction then attached Receives: Procedure: EUS-guided liver biopsy |
| Wet Heparin | Experimental | EUS-guided liver biopsy with needle flushed with heparin, 2 cc of liquid added to suction then attached. Receives: Procedure: EUS-guided liver biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Proportion of cases for which a histologic diagnosis could be made based upon the amount of tissue obtained with the needle
Measured: 7 days
Secondary outcomes (9)
The Number of patients with a visible core after needle biopsy
Day of Procedure
Measured: Presence of a visible core specimen (yes/no) at time 7 days
The Number of patients with a visible clot after needle biopsy
Day of Procedure
Measured: Presence of visible clots in specimen (yes/no) at time 7 days
The Number of patients with visible bleeding after needle biopsy
Patient with blood visible from patient's mouth, rectum with a 2 gram drop in hemoglobin
Measured: 7 Days
The Number of patients with Pain 1 Day after needle biopsy
Pain using Likert score 0-10 (10 worst)
Measured: 1 Days
The Number of patients with Pain 7 Day after needle biopsy
Pain using Likert score 0-10 (10 worst)
Measured: 7 Days
The Number of patients requiring medical care after needle biopsy
Patient requiring visit to healthcare center (emergency room, hospital, call to service) within time 7 days
Measured: 7 Days
Number of portal tracts (PT) in the specimen (total) under histologic examination
Number of portal tracts (PT) in the specimen (total) under histologic examination
Measured: 7 Days
Aggregate Specimen Length under histologic examination
Length of all the tissue (centimeters) by adding the sum of all pieces
Measured: 7 Days
Length of the longest piece under histologic examination
length of the longest tissue biopsy piece (centimeters) as measured by pathology
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start6 Jan 2017
- Primary completion1 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David L Diehl, M.D., Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103997
- Sponsor's protocol ID
- 2016-0300
- Status last verified
- Aug 2018
- First submitted
- 14 Mar 2017
- Last updated
- 23 Aug 2018
- 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, Polkowski M, Larghi A, Vilmann P, Giovannini M, Frossard JL, Heresbach D, Pujol B, Fernandez-Esparrach G, Vazquez-Sequeiros E, Gines A; European Society of Gastrointestinal Endoscopy. Indications, results, and clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2011 Oct;43(10):897-912. doi: 10.1055/s-0030-1256754. Epub 2011 Aug 12.
PubMed 21842456Hebert-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 14502798Harada N, Kouzu T, Arima M, Isono K. Endoscopic ultrasound-guided histologic needle biopsy: preliminary results using a newly developed endoscopic ultrasound transducer. Gastrointest Endosc. 1996 Sep;44(3):327-30. doi: 10.1016/s0016-5107(96)70173-6. No abstract available.
PubMed 8885355Binmoeller KF, Thul R, Rathod V, Henke P, Brand B, Jabusch HC, Soehendra N. Endoscopic ultrasound-guided, 18-gauge, fine needle aspiration biopsy of the pancreas using a 2.8 mm channel convex array echoendoscope. Gastrointest Endosc. 1998 Feb;47(2):121-7. doi: 10.1016/s0016-5107(98)70343-8.
PubMed 9512275Voss M, Hammel P, Molas G, Palazzo L, Dancour A, O'Toole D, Terris B, Degott C, Bernades P, Ruszniewski P. Value of endoscopic ultrasound guided fine needle aspiration biopsy in the diagnosis of solid pancreatic masses. Gut. 2000 Feb;46(2):244-9. doi: 10.1136/gut.46.2.244.
PubMed 10644320Varadarajulu S, Fraig M, Schmulewitz N, Roberts S, Wildi S, Hawes RH, Hoffman BJ, Wallace MB. Comparison of EUS-guided 19-gauge Trucut needle biopsy with EUS-guided fine-needle aspiration. Endoscopy. 2004 May;36(5):397-401. doi: 10.1055/s-2004-814316.
PubMed 15100946Shah SM, Ribeiro A, Levi J, Jorda M, Rocha-Lima C, Sleeman D, Hamilton-Nelson K, Ganjei-Azar P, Barkin J. EUS-guided fine needle aspiration with and without trucut biopsy of pancreatic masses. JOP. 2008 Jul 10;9(4):422-30.
PubMed 18648133Thomas 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 19262518Levy MJ, Jondal ML, Clain J, Wiersema MJ. Preliminary experience with an EUS-guided trucut biopsy needle compared with EUS-guided FNA. Gastrointest Endosc. 2003 Jan;57(1):101-6. doi: 10.1067/mge.2003.49.
PubMed 12518144Iglesias-Garcia J, Poley JW, Larghi A, Giovannini M, Petrone MC, Abdulkader I, Monges G, Costamagna G, Arcidiacono P, Biermann K, Rindi G, Bories E, Dogloni C, Bruno M, Dominguez-Munoz JE. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc. 2011 Jun;73(6):1189-96. doi: 10.1016/j.gie.2011.01.053. Epub 2011 Mar 21.
PubMed 21420083Larghi A, Iglesias-Garcia J, Poley JW, Monges G, Petrone MC, Rindi G, Abdulkader I, Arcidiacono PG, Costamagna G, Biermann K, Bories E, Doglioni C, Dominguez-Munoz JE, Hassan C, Bruno M, Giovannini M. Feasibility and yield of a novel 22-gauge histology EUS needle in patients with pancreatic masses: a multicenter prospective cohort study. Surg Endosc. 2013 Oct;27(10):3733-8. doi: 10.1007/s00464-013-2957-9. Epub 2013 May 4.
PubMed 23644834
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. 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 Liver Biopsy (EUS-LB): A Prospective Trial
- ClinicalTrials.gov ID
- NCT03103997
- Acronym / sponsor ID
- 2016-0300
- Conditions
- Liver Diseases
- Keywords
- Liver, EUS, Biopsy, Heparin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 7 Apr 2017 (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.
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).
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
- Proportion of cases for which a histologic diagnosis could be made based upon the amount of tissue obtained with the needle.
- Number of portal tracts (PT) in the specimen
- Aggregate specimen length (ASL), length of the longest piece (LLP), and degree of fragmentation Secondary End Points
- 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| New Needle | Active comparator | Procedure: EUS-guided liver biopsyEUS-guided liver biopsy with needle and suction, no preparation |
| Dry Heparin | Experimental | Procedure: EUS-guided liver biopsyEUS-guided liver biopsy with needle flushed with heparin, then flushed with air, suction then attached |
| Wet Heparin | Experimental | Procedure: EUS-guided liver biopsyEUS-guided liver biopsy with needle flushed with heparin, 2 cc of liquid added to suction then attached. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing EUS-LB
- Platelet count > 50,000
- International normalized ratio (INR) < 1.5
- Age > 18 years
- Non-pregnant patients
Key exclusion criteria (11 listed)
- Age < 18 years
- Pregnant Patients
- Inability to obtain consent
- Anticoagulants or anti-platelet agents use (excluding aspirin) within the last 7-10 days
- Platelet count < 50,000
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 |
|---|---|---|
| EUS-guided liver biopsyEUS-guided liver biopsy using needles with various preparations | Procedure or surgery | Dry Heparin, New Needle, Wet Heparin |
Primary outcome
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
9 secondary outcomes
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
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
The Number of patients with visible bleeding after needle biopsy
Time frame: 7 Days
The Number of patients with Pain 1 Day after needle biopsy
Time frame: 1 Days
The Number of patients with Pain 7 Day after needle biopsy
Time frame: 7 Days
The Number of patients requiring medical care after needle biopsy
Time frame: 7 Days
Number of portal tracts (PT) in the specimen (total) under histologic examination
Time frame: 7 Days
Aggregate Specimen Length under histologic examination
Time frame: 7 Days
Length of the longest piece under histologic examination
Time frame: 7 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Results publication: 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.
- Results publication: PubMed 21842456Dumonceau JM, Polkowski M, Larghi A, Vilmann P, Giovannini M, Frossard JL, Heresbach D, Pujol B, Fernandez-Esparrach G, Vazquez-Sequeiros E, Gines A; European Society of Gastrointestinal Endoscopy. Indications, results, and clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2011 Oct;43(10):897-912. doi: 10.1055/s-0030-1256754. Epub 2011 Aug 12.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 8885355Harada N, Kouzu T, Arima M, Isono K. Endoscopic ultrasound-guided histologic needle biopsy: preliminary results using a newly developed endoscopic ultrasound transducer. Gastrointest Endosc. 1996 Sep;44(3):327-30. doi: 10.1016/s0016-5107(96)70173-6. No abstract available.
- Results publication: PubMed 9512275Binmoeller KF, Thul R, Rathod V, Henke P, Brand B, Jabusch HC, Soehendra N. Endoscopic ultrasound-guided, 18-gauge, fine needle aspiration biopsy of the pancreas using a 2.8 mm channel convex array echoendoscope. Gastrointest Endosc. 1998 Feb;47(2):121-7. doi: 10.1016/s0016-5107(98)70343-8.
- Results publication: PubMed 10644320Voss M, Hammel P, Molas G, Palazzo L, Dancour A, O'Toole D, Terris B, Degott C, Bernades P, Ruszniewski P. Value of endoscopic ultrasound guided fine needle aspiration biopsy in the diagnosis of solid pancreatic masses. Gut. 2000 Feb;46(2):244-9. doi: 10.1136/gut.46.2.244.
- Results publication: PubMed 15100946Varadarajulu S, Fraig M, Schmulewitz N, Roberts S, Wildi S, Hawes RH, Hoffman BJ, Wallace MB. Comparison of EUS-guided 19-gauge Trucut needle biopsy with EUS-guided fine-needle aspiration. Endoscopy. 2004 May;36(5):397-401. doi: 10.1055/s-2004-814316.
- Results publication: PubMed 18648133Shah SM, Ribeiro A, Levi J, Jorda M, Rocha-Lima C, Sleeman D, Hamilton-Nelson K, Ganjei-Azar P, Barkin J. EUS-guided fine needle aspiration with and without trucut biopsy of pancreatic masses. JOP. 2008 Jul 10;9(4):422-30.
- Results publication: PubMed 19262518Thomas 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.
- 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.
David L Diehl, M.D. principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-guided liver biopsy in people with Liver Diseases, run by Geisinger Clinic 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 11 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: finished, as of the sponsor's last update on 23 Aug 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). 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 NCT03103997, which also lists 38 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 23 Aug 2018.