Pancreatic TumorNCT01698190
Comparing the Efficacy of Endoscopic FNA vs FNB in Diagnosing Solid Gastrointestinal Lesions
A study testing Endoscopic ultrasound guided needle tissue acquisition. in people with Pancreatic Tumor and Gastric Tumor, run by Stony Brook University at 1 site in United States.
Trial summary
The purpose of this study is to determine if fine needle aspiration or fine needle biopsy is more efficacious and cost-effective than the other while maintaining diagnostic accuracy in the setting of solid gastrointestinal lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Tumor, Gastric Tumor, Esophageal Tumor
- What is being tested?
- Endoscopic ultrasound guided needle tissue acquisition.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Dec 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive adult patients who require endoscopic ultrasound and tissue sampling of either a) pancreatic solid lesion, b) subepithelial solid lesion of the esophagus, stomach, duodenum or rectum, c) liver lesion, or d) lymph nodes or mass lesion located adjacent to the esophagus, stomach, duodenum or rectum
- Ability to give consent
Who cannot join
- Inability to obtain informed consent
- Pregnant patients
- Patients under the age of 18
- Severe cardiopulmonary disease preventing a safe EUS procedure
- Patients unable to safely stop anti-coagulation therapy prior to EUS procedure
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University Hospital
Stony Brook, New York, 11794
Satish Nagula, M.D.
About this study
Official title: Comparing the Overall Efficacy of Endoscopic Ultrasound Fine Needle Aspiration Versus Fine Needle Biopsy in the Diagnosis of Solid Lesions: A Multicenter, Randomized Clinical Trial
The purpose of this study is to determine if fine needle aspiration or fine needle biopsy is more efficacious and cost-effective than the other while maintaining diagnostic accuracy in the setting of solid gastrointestinal lesions.
Read the detailed description
When ultrasound is used during endoscopy, we are able to visualize the structures adjacent to the gastrointestinal tract in close detail. Once the mass is visualized, we use endoscopic ultrasound to obtain a tissue sample, which the pathologist can examine in order to provide a diagnosis.
The conventional method for obtaining a sample of tissue with endoscopic ultrasound is called fine needle aspiration (FNA). This involves the insertion of a thin needle into the mass and obtaining a small sample of tissue which the pathologist can examine. An alternative technique is called fine needle biopsy (FNB), and involves the insertion of a thin double-edged needle into the mass. This double-edged needle may potentially provide a larger sample of tissue to examine.
Both of these techniques are commonly used, and both methods are equally safe. However, it is not known if one of these techniques is more effective at obtaining a sample of tissue or if one of these techniques is more cost-effective than the other. The purpose of this study is to determine if one method is more efficacious and cost-effective than the other while maintaining diagnostic accuracy. The results of this study may alter the way gastroenterologists obtain tissue samples during endoscopic ultrasound, improving the utility of the exam and reducing unnecessary healthcare costs.
- Being tested
- Endoscopic ultrasound guided needle tissue acquisition.
- Medical subject headings
- Pancreatic Neoplasms, Stomach Neoplasms, Esophageal Neoplasms, Lymphadenopathy, Duodenal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound guided needle tissue acquisition.Procedure or surgery
Also called Echotip ProCore
Endoscopic ultrasound with fine needle aspiration (FNA) allows for the safe and efficacious sampling of solid lesions that are in close proximity to the gastrointestinal tract, including extraintestinal masses, subepithelial tumors, and peri-intestinal lymphadenopathy. Fine needle core biopsy (FNB) has the potential of accruing larger tissue samples during biopsies, which may make the procedure more efficacious. In our study, we are comparing the overall efficacy between these two needles which are currently both used as standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Fine needle aspiration (FNA) | Active comparator | Endoscopic ultrasound guided needle tissue acquisition: Tissue acquisition using a standard FNA needle Receives: Procedure: Endoscopic ultrasound guided needle tissue acquisition. |
| Fine needle biopsy (FNB) | Active comparator | Endoscopic ultrasound guided needle tissue acquisition: Tissue acquisition using a new Core needle (Procore; Fine Needle Biopsy). Receives: Procedure: Endoscopic ultrasound guided needle tissue acquisition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of needle passes needed to obtain a pathologic diagnosis.
Measured: Within 1 week of study enrollment
Secondary outcomes (3)
Diagnostic yield, defined as percentage of cases with a diagnostic biopsy sample, between FNA and FNB.
Measured: By three months post-op in the pathology report
Visible core specimens obtained and its correlation to obtaining a diagnostic sample.
Measured: During the intervention itself
Frequency of adverse side effects.
Measured: Three months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pancreatic TumorStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- New York Medical College, Yale University, Icahn School of Medicine at Mount Sinai, Columbia University, Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Satish Nagula, MD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698190
- Sponsor's protocol ID
- SBUGI-2012
- Status last verified
- Nov 2014
- First submitted
- 25 May 2012
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
ASGE Standards of Practice Committee; Gan SI, Rajan E, Adler DG, Baron TH, Anderson MA, Cash BD, Davila RE, Dominitz JA, Harrison ME 3rd, Ikenberry SO, Lichtenstein D, Qureshi W, Shen B, Zuckerman M, Fanelli RD, Lee KK, Van Guilder T. Role of EUS. Gastrointest Endosc. 2007 Sep;66(3):425-34. doi: 10.1016/j.gie.2007.05.026. Epub 2007 Jul 23. No abstract available.
PubMed 17643438Gress FG, Hawes RH, Savides TJ, Ikenberry SO, Lehman GA. Endoscopic ultrasound-guided fine-needle aspiration biopsy using linear array and radial scanning endosonography. Gastrointest Endosc. 1997 Mar;45(3):243-50. doi: 10.1016/s0016-5107(97)70266-9.
PubMed 9087830Wiersema MJ, Vilmann P, Giovannini M, Chang KJ, Wiersema LM. Endosonography-guided fine-needle aspiration biopsy: diagnostic accuracy and complication assessment. Gastroenterology. 1997 Apr;112(4):1087-95. doi: 10.1016/s0016-5085(97)70164-1.
PubMed 9097990Iglesias-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 21483464Schwartz DA, Unni KK, Levy MJ, Clain JE, Wiersema MJ. The rate of false-positive results with EUS-guided fine-needle aspiration. Gastrointest Endosc. 2002 Dec;56(6):868-72. doi: 10.1067/mge.2002.129610.
PubMed 12447300Iglesias-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 21420083Camellini L, Carlinfante G, Azzolini F, Iori V, Cavina M, Sereni G, Decembrino F, Gallo C, Tamagnini I, Valli R, Piana S, Campari C, Gardini G, Sassatelli R. A randomized clinical trial comparing 22G and 25G needles in endoscopic ultrasound-guided fine-needle aspiration of solid lesions. Endoscopy. 2011 Aug;43(8):709-15. doi: 10.1055/s-0030-1256482. Epub 2011 May 24.
PubMed 21611946Nagula S, Pourmand K, Aslanian H, Bucobo JC, Gonda TA, Gonzalez S, Goodman A, Gross SA, Ho S, DiMaio CJ, Kim MK, Pais S, Poneros JM, Robbins DH, Schnoll-Sussman F, Sethi A, Buscaglia JM; New York Endoscopic Research Outcomes Group (NYERO). Comparison of Endoscopic Ultrasound-Fine-Needle Aspiration and Endoscopic Ultrasound-Fine-Needle Biopsy for Solid Lesions in a Multicenter, Randomized Trial. Clin Gastroenterol Hepatol. 2018 Aug;16(8):1307-1313.e1. doi: 10.1016/j.cgh.2017.06.013. Epub 2017 Jun 15.
PubMed 28624647
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Overall Efficacy of Endoscopic Ultrasound Fine Needle Aspiration Versus Fine Needle Biopsy in the Diagnosis of Solid Lesions: A Multicenter, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01698190
- Acronym / sponsor ID
- SBUGI-2012
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- New York Medical College, Yale University, Icahn School of Medicine at Mount Sinai, Columbia University, Weill Medical College of Cornell University
- Study start
- Dec 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 2 Oct 2012 (estimated)
- 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 study is to determine if fine needle aspiration or fine needle biopsy is more efficacious and cost-effective than the other while maintaining diagnostic accuracy in the setting of solid gastrointestinal lesions.
Detailed description
When ultrasound is used during endoscopy, we are able to visualize the structures adjacent to the gastrointestinal tract in close detail. Once the mass is visualized, we use endoscopic ultrasound to obtain a tissue sample, which the pathologist can examine in order to provide a diagnosis.
The conventional method for obtaining a sample of tissue with endoscopic ultrasound is called fine needle aspiration (FNA). This involves the insertion of a thin needle into the mass and obtaining a small sample of tissue which the pathologist can examine. An alternative technique is called fine needle biopsy (FNB), and involves the insertion of a thin double-edged needle into the mass. This double-edged needle may potentially provide a larger sample of tissue to examine.
Both of these techniques are commonly used, and both methods are equally safe. However, it is not known if one of these techniques is more effective at obtaining a sample of tissue or if one of these techniques is more cost-effective than the other. The purpose of this study is to determine if one method is more efficacious and cost-effective than the other while maintaining diagnostic accuracy. The results of this study may alter the way gastroenterologists obtain tissue samples during endoscopic ultrasound, improving the utility of the exam and reducing unnecessary healthcare costs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fine needle aspiration (FNA) | Active comparator | Procedure: Endoscopic ultrasound guided needle tissue acquisition.Endoscopic ultrasound guided needle tissue acquisition: Tissue acquisition using a standard FNA needle |
| Fine needle biopsy (FNB) | Active comparator | Procedure: Endoscopic ultrasound guided needle tissue acquisition.Endoscopic ultrasound guided needle tissue acquisition: Tissue acquisition using a new Core needle (Procore; Fine Needle Biopsy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Consecutive adult patients who require endoscopic ultrasound and tissue sampling of either a) pancreatic solid lesion, b) subepithelial solid lesion of the esophagus, stomach, duodenum or rectum, c) liver lesion, or d) lymph nodes or mass lesion located adjacent to the esophagus, stomach, duodenum or rectum
- Ability to give consent
Key exclusion criteria (5 listed)
- Inability to obtain informed consent
- Pregnant patients
- Patients under the age of 18
- Severe cardiopulmonary disease preventing a safe EUS procedure
- Patients unable to safely stop anti-coagulation therapy prior to EUS procedure
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 |
|---|---|---|
| Endoscopic ultrasound guided needle tissue acquisition.Also: Echotip ProCoreEndoscopic ultrasound with fine needle aspiration (FNA) allows for the safe and efficacious sampling of solid lesions that are in close proximity to the gastrointestinal tract, including extraintestinal masses, subepithelial tumors, and peri-intestinal lymphadenopathy. Fine needle core biopsy (FNB) has the potential of accruing larger tissue samples during biopsies, which may make the procedure more efficacious. In our study, we are comparing the overall efficacy between these two needles which are currently both used as standard of care. | Procedure or surgery | Fine needle aspiration (FNA), Fine needle biopsy (FNB) |
Primary outcome
Number of needle passes needed to obtain a pathologic diagnosis.
Time frame: Within 1 week of study enrollment
3 secondary outcomes
Diagnostic yield, defined as percentage of cases with a diagnostic biopsy sample, between FNA and FNB.
Time frame: By three months post-op in the pathology report
Visible core specimens obtained and its correlation to obtaining a diagnostic sample.
Time frame: During the intervention itself
Frequency of adverse side effects.
Time frame: Three months post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
- Background: PubMed 17643438ASGE Standards of Practice Committee; Gan SI, Rajan E, Adler DG, Baron TH, Anderson MA, Cash BD, Davila RE, Dominitz JA, Harrison ME 3rd, Ikenberry SO, Lichtenstein D, Qureshi W, Shen B, Zuckerman M, Fanelli RD, Lee KK, Van Guilder T. Role of EUS. Gastrointest Endosc. 2007 Sep;66(3):425-34. doi: 10.1016/j.gie.2007.05.026. Epub 2007 Jul 23. No abstract available.
- Background: PubMed 9087830Gress FG, Hawes RH, Savides TJ, Ikenberry SO, Lehman GA. Endoscopic ultrasound-guided fine-needle aspiration biopsy using linear array and radial scanning endosonography. Gastrointest Endosc. 1997 Mar;45(3):243-50. doi: 10.1016/s0016-5107(97)70266-9.
- Background: PubMed 9097990Wiersema MJ, Vilmann P, Giovannini M, Chang KJ, Wiersema LM. Endosonography-guided fine-needle aspiration biopsy: diagnostic accuracy and complication assessment. Gastroenterology. 1997 Apr;112(4):1087-95. doi: 10.1016/s0016-5085(97)70164-1.
- 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 12447300Schwartz DA, Unni KK, Levy MJ, Clain JE, Wiersema MJ. The rate of false-positive results with EUS-guided fine-needle aspiration. Gastrointest Endosc. 2002 Dec;56(6):868-72. doi: 10.1067/mge.2002.129610.
- Background: PubMed 21420083Iglesias-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.
- Background: PubMed 21611946Camellini L, Carlinfante G, Azzolini F, Iori V, Cavina M, Sereni G, Decembrino F, Gallo C, Tamagnini I, Valli R, Piana S, Campari C, Gardini G, Sassatelli R. A randomized clinical trial comparing 22G and 25G needles in endoscopic ultrasound-guided fine-needle aspiration of solid lesions. Endoscopy. 2011 Aug;43(8):709-15. doi: 10.1055/s-0030-1256482. Epub 2011 May 24.
- Derived from this study: PubMed 28624647Nagula S, Pourmand K, Aslanian H, Bucobo JC, Gonda TA, Gonzalez S, Goodman A, Gross SA, Ho S, DiMaio CJ, Kim MK, Pais S, Poneros JM, Robbins DH, Schnoll-Sussman F, Sethi A, Buscaglia JM; New York Endoscopic Research Outcomes Group (NYERO). Comparison of Endoscopic Ultrasound-Fine-Needle Aspiration and Endoscopic Ultrasound-Fine-Needle Biopsy for Solid Lesions in a Multicenter, Randomized Trial. Clin Gastroenterol Hepatol. 2018 Aug;16(8):1307-1313.e1. doi: 10.1016/j.cgh.2017.06.013. Epub 2017 Jun 15.
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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.
Satish Nagula, MD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasound guided needle tissue acquisition. in people with Pancreatic Tumor and Gastric Tumor, run by Stony Brook University 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Nov 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Satish Nagula, M.D. (631-444-2119, satish.nagula@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of needle passes needed to obtain a pathologic diagnosis. (time frame: Within 1 week of study enrollment). 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 NCT01698190, which also lists 8 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 19 Nov 2014; AzTrials last refreshed its copy on 7 Nov 2026.