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| Name | Class |
|---|---|
| Cook Ireland, Ltd. | INDUSTRY |
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The aim of this study is to compare the diagnostic accuracy of two EUS-guided tissue acquisition devices; the 25G Echotip Ultra Fine Needle Aspiration (FNA) device and the 20G Echotip ProCore Fine Needle Biopsy (FNB) device.
Endoscopic ultrasound (EUS)-guided tissue acquisition has emerged as a valuable method to diagnose and stage malignancies. During Endoscopic Ultrasound (EUS), tissue samples can be obtained for pathological evaluation with different devices. Fine needle aspiration (FNA) provides a cytological specimen. Unfortunately, in a cytological specimen, inflammatory changes may be undistinguishable from well-differentiated dysplasia. Moreover, for neoplasms such as lymphomas and stromal tumors, tissue architecture and cell morphology are essential for accurate pathological assessment. Therefore, pathologists generally prefer a histological specimen. Fine needle biopsy (FNB) has the advantage of obtaining a histological specimen, which may lead to better diagnostic performance. However, FNB needles are stiffer and more difficult to handle, which can complicate tissue acquisition. In addition, the superiority of histology over cytology in EUS-guided tissue sampling has not been proven yet. For instance, tissue, obtained by FNA and processed with the new cell-block technique, may equal the diagnostic yield of histological tissue cores.
A recent meta-analysis suggested that 25G is the optimal FNA needle size to obtain an adequate cytological specimen. In this study, we aim to compare the properties and merits of a newly designed, more flexible, 20G EUS ProCore FNB device to a conventional 25G EUS-FNA device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 25G FNA needle | Active Comparator | Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). |
|
| 20G ProCore FNB needle | Active Comparator | Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 25G FNA needle | Device |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy | Diagnostic accuracy is the number of correctly diagnosed cases as compared to gold standard diagnosis Gold standard diagnosis is defined as;
| 27 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in Whom Target Lesion Was Sampled | records if a target lesion was reached during the procedure using the randomised needle or not | 1 day |
| Presence of Vital Target Cells Per Case, Per Needle Type |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco J Bruno, MD, PhD | Erasmus Medical Center | Study Chair |
| Djuna L Cahen, MD, PhD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California | Irvine | California | CA 92868 | United States | ||
| Yale University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31330556 | Derived | van Riet PA, Giorgio Arcidiacono P, Petrone M, Quoc Nguyen N, Kitano M, Chang K, Larghi A, Iglesias-Garcia J, Giovannini M, van der Merwe S, Santo E, Baldaque-Silva F, Bucobo JC, Bruno MJ, Aslanian HR, Cahen DL, Farrell J. Combined versus single use 20 G fine-needle biopsy and 25 G fine-needle aspiration for endoscopic ultrasound-guided tissue sampling of solid gastrointestinal lesions. Endoscopy. 2020 Jan;52(1):37-44. doi: 10.1055/a-0966-8755. Epub 2019 Jul 22. | |
| 30367877 |
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3 patients were included but met exclusion criteria 4 patients were lost to follow-up
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| ID | Title | Description |
|---|---|---|
| FG000 | 25G FNA Needle | Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 25G FNA needle |
| FG001 | 20G ProCore FNB Needle | Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 20G ProCore FNB needle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 25G FNA Needle | Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 25G FNA needle |
| BG001 | 20G ProCore FNB Needle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Diagnostic Accuracy | Diagnostic accuracy is the number of correctly diagnosed cases as compared to gold standard diagnosis Gold standard diagnosis is defined as;
| Posted | Count of Participants | Participants | 27 months |
|
27 months
it does not differ, 5 adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 25G FNA Needle | Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 25G FNA needle |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. P. van Riet | Erasmusm MC University Medical Center Rotterdam | 0031648237608 | p.vanriet@erasmusmc.nl |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 13, 2014 | Aug 4, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 13, 2014 | Feb 24, 2020 | SAP_001.pdf |
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| 20G ProCore FNB needle |
| Device |
|
|
Presence of sufficient vital target cells, as in, target organ cells to provide a diagnosis (yes or no)
| after 27 months |
| Number of Patients With Adverse Events Per Needle Type | adverse events per needle type, up to 27 months after procedure | 27 months after procedure |
| Diagnostic Yield of the First Needle Pass | Yield is expressed as sample sufficiency for diagnostic analysis by pathologists, this was either sufficient or not | after 27 months |
| On-site Pathological Evaluation Performed | Presence of pathologist on site during procedure | 27 months |
| New Haven |
| Connecticut |
| CT 06520 |
| United States |
| Stony Brook University Hospital | New York | New York | NY 11794 | United States |
| The Royal Adelaide Hospital | Adelaide | Australia |
| University Hospital Leuven | Leuven | Belgium |
| Institut Paoli-Calmettes | Marseille | France |
| Tel Aviv Sourasky Medical Center | Tel Aviv | Israel |
| Vita Salute San Raffaele University | Milan | Italy |
| Catholic University Rome | Rome | Italy |
| Kinki University | ÅŒsaka-sayama | Japan |
| Erasmus University Medical Center | Rotterdam | South Holland | 3015 CE | Netherlands |
| University Hospital of Santiago de Compostella | Santiago de Compostela | Spain |
| Karolinska University Hospital | Stockholm | Sweden |
| Derived |
| van Riet PA, Larghi A, Attili F, Rindi G, Nguyen NQ, Ruszkiewicz A, Kitano M, Chikugo T, Aslanian H, Farrell J, Robert M, Adeniran A, Van Der Merwe S, Roskams T, Chang K, Lin F, Lee JG, Arcidiacono PG, Petrone M, Doglioni C, Iglesias-Garcia J, Abdulkader I, Giovannini M, Bories E, Poizat F, Santo E, Scapa E, Marmor S, Bucobo JC, Buscaglia JM, Heimann A, Wu M, Baldaque-Silva F, Moro CF, Erler NS, Biermann K, Poley JW, Cahen DL, Bruno MJ. A multicenter randomized trial comparing a 25-gauge EUS fine-needle aspiration device with a 20-gauge EUS fine-needle biopsy device. Gastrointest Endosc. 2019 Feb;89(2):329-339. doi: 10.1016/j.gie.2018.10.026. Epub 2018 Oct 24. |
Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic).
20G ProCore FNB needle
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic).
20G ProCore FNB needle
|
|
| Secondary | Number of Participants in Whom Target Lesion Was Sampled | records if a target lesion was reached during the procedure using the randomised needle or not | Posted | Count of Participants | Participants | 1 day |
|
|
|
| Secondary | Presence of Vital Target Cells Per Case, Per Needle Type | Presence of sufficient vital target cells, as in, target organ cells to provide a diagnosis (yes or no) | Posted | Count of Participants | Participants | after 27 months |
|
|
|
|
| Secondary | Number of Patients With Adverse Events Per Needle Type | adverse events per needle type, up to 27 months after procedure | Posted | Count of Participants | Participants | 27 months after procedure |
|
|
|
| Secondary | Diagnostic Yield of the First Needle Pass | Yield is expressed as sample sufficiency for diagnostic analysis by pathologists, this was either sufficient or not | Yield is expressed as sample sufficiency for diagnostic analysis by pathologists, this was either sufficient or not | Posted | Count of Participants | Participants | after 27 months |
|
|
|
| Secondary | On-site Pathological Evaluation Performed | Presence of pathologist on site during procedure | Posted | Number | participants | 27 months |
|
|
|
| 0 |
| 306 |
| 0 |
| 306 |
| 3 |
| 306 |
| EG001 | 20G ProCore FNB Needle | Patients referred for EUS-guided tissue acquisition of a pancreatic mass, lymph node, or other submucosal or undefined mass (non-pancreatic). 20G ProCore FNB needle | 0 | 302 | 0 | 302 | 2 | 302 |
| pain | General disorders | Non-systematic Assessment |
|
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