Procore

Manufactured by Cook Medical

Sourced in United States

ProCore is a lab equipment product designed for core sample extraction. It is used to obtain cylindrical samples from various materials for analysis and testing purposes.

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Lab products found in correlation

Sharkcore, by Medtronic (4 mentions) Echotip, by Cook Medical (4 mentions) Gf uct180, by Olympus (4 mentions) Franseen needle, by Boston Scientific (2 mentions) Echotip ultra, by Cook Medical (2 mentions) Prosound ssd α 10, by Hitachi (1 mentions) Gf uct260, by Olympus (1 mentions) Gf uct240, by Olympus (1 mentions)

10 protocols using procore

Evaluation of EUS-guided LN Tissue Sampling

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Studies included in this meta-analysis were randomized–controlled trials (RCTs) or retrospective comparative series that met the following inclusion criteria: (i) patients: adult patients with mediastinal or abdominal lymphodenopathy of unclear origin; (ii) intervention: EUS-guided LN tissue sampling through FNB (reverse-bevel [ProCore^®, Cook Medical Inc., Bloomington, Indiana, USA], Franseen needle [Acquire^®, Boston Scientific, Marlborough, Massachusetts, USA], and the Fork-tip needle [SharkCore^®, Medtronic, Dublin, Ireland]); (iii) comparator: EUS-FNA of LNs; and (iv) outcomes: primary outcome was diagnostic accuracy, and secondary outcomes were histological core procurement, sample adequacy, diagnostic sensitivity, specificity, number of needle passes. Safety data were also analysed.
We excluded (i) non-comparative single cohort studies, (ii) case series with <10 patients per arm, (iii) studies not reporting any of the aforementioned outcomes, and (iv) studies evaluating endobronchial ultrasound-guided sampling of mediastinal LNs.

Facciorusso A., Crinò S.F., Gkolfakis P., Ramai D., Lisotti A., Papanikolaou I.S., Mangiavillano B., Tarantino I., Anderloni A., Fabbri C., Triantafyllou K, & Fusaroli P. (2022). Endoscopic ultrasound fine-needle biopsy vs fine-needle aspiration for lymph nodes tissue acquisition: a systematic review and meta-analysis. Gastroenterology Report, 10, goac062.

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Comparison of FNB and FNA Needles

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In the course of the ASPRO trial (ClinicalTrials.gov: NCT02167074), 13 EUS centers randomized 608 consecutive patients with a solid pancreatic lesion, lymph node, or submucosal or other solid lesion to sampling with a 20‐G FNB (ProCore; Cook Medical) or with a 25‐G FNA needle (EchoTip Ultra; Cook Medical), between February 2015 and September 2016. Parameters regarding specimen characteristics and diagnostic accuracy were compared. Gold standard diagnosis was based on the prior ASPRO study17 either on pathological evaluation of the surgical resection specimens or on clinical follow up for at least 9 months when surgical resection was not indicated. Gold standard diagnosis was recorded by the principal investigator of each of the participating centers.
For the present side‐study, the first 125 pancreatic and lymph node cases that were enrolled in the ASPRO study were included. Samples from these cases were reassessed by five expert academic and five non‐academic pathologists. Diagnosis of malignancy and quality scores were assessed, and agreement on these outcome measures was compared between the two needles and between academic and non‐academic pathologists.
As our study was a clinical trial, all authors could access the study data and have reviewed and approved the final manuscript.

van Riet P.A., Cahen D.L., Biermann K., Hansen B., Larghi A., Rindi G., Fellegara G., Arcidiacono P., Doglioni C., Liberta Decarli N., Iglesias‐Garcia J., Abdulkader I., Lazare Iglesias H., Kitano M., Chikugo T., Yasukawa S., van der Valk H., Nguyen N.Q., Ruszkiewicz A., Giovannini M., Poizat F., van der Merwe S., Roskams T., Santo E., Marmor S., Chang K., Lin F., Farrell J., Robert M., Bucobo J.C., Heimann A., Baldaque‐Silva F., Fernández Moro C., Bruno M.J., Attili F., Aslanian H., Adeniran A., Lee J.G., Petrone M., Bories E., Scapa E., Buscaglia J.M, & Wu M. (2019). Agreement on endoscopic ultrasonography‐guided tissue specimens: Comparing a 20‐G fine‐needle biopsy to a 25‐G fine‐needle aspiration needle among academic and non‐academic pathologists. Digestive Endoscopy, 31(6), 690-697.

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Endoscopic Ultrasound-Guided Fine-Needle Aspiration

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EUS-FNA was performed using a curvilinear echoendoscope (GF-UCT 240 or GF-UCT 260; Olympus, Tokyo, Japan) with corresponding display units (Prosound SSD α-10; Hitachi Aloka Medical, Tokyo, Japan). EUS procedures were carried out with the patient in the left lateral position under conscious sedation using pethidine hydrochloride and diazepam. EUS-FNA was performed with the same 25-G needle (Echotip^® or Procore^®; Cook Medical, Bloomington, IN, USA, SonoTip Pro Control^®; Medi-Globe, Achenmühle, Germany, or Expect^®; Boston Scientific, Natick, MA, USA) in the first and second passes. We choose a 25-G needle for flexibility of access, even with a transduodenal approach. After the second pass, the endosonographer performed EUS-FNA with a 25-, 22-, 21-, or 19-G needle (Echotip^®; Procore^®; SonoTip Pro Control^®; Expect^®; or an EUS SONOPSY CY^®; Hakko, Nagano, Japan). The choice of needle was based on the operator’s preference to achieve the safest and most successful puncture. Suction was applied with a 10-mL or 20-mL syringe while the needle was moved 20 times per needle pass within the lesion. The needle pass was repeated until enough specimens were obtained, with a minimum of 2 and a maximum of 6 passes. Adverse events were defined based on a lexicon for endoscopic adverse events described by the American Society Gastrointestinal Endoscopy [18 (link)].

Harada R., Kato H., Fushimi S., Inoue H., Uchida D., Akimoto Y., Tomoda T., Matsumoto K., Noma Y., Yamamoto N., Horiguchi S., Tsutsumi K, & Okada H. (2019). A “Back Light System” for Identification of Sites for Endoscopic Ultrasound-Guided Fine-Needle Aspiration in Solid Pancreatic Masses: A Prospective, Randomized Study with a Crossover Design. Clinical Endoscopy, 52(4), 334-339.

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EUS-Guided Tissue Sampling Techniques

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All EUS-guided tissue sampling procedures were performed using a linear array echoendoscope (Olympus GF-UCT180; Olympus, Center Valley, PA, USA) under deep sedation with monitored anesthesia care by experienced endosonographers or by gastroenterology fellows under direct expert supervision. Several different needles were used during this study period, including 22 G and 25 G FNA needles (Expect; Boston Scientific Co., Natick, MA, USA or Echotip; Cook Medical, Winston-Salem, NC, USA or Beacon; Medtronic Co., Newton, MA, USA) and 20 G, 22 G, and 25 G FNB needles (Acquire; Boston Scientific, or SharkCore; Medtronic, or ProCore; Cook Medical). No predefined protocol was used in the study. In general, after lesions were identified and punctured under EUS guidance, a fanning technique was performed. Individual operator technique varied between centers, including stylet slow-pull technique and standard suction.

de Moura D.T., McCarty T.R., Jirapinyo P., Ribeiro I.B., Farias G.F., Ryou M., Lee L.S, & Thompson C.C. (2019). Endoscopic Ultrasound Fine-Needle Aspiration versus Fine-Needle Biopsy for Lymph Node Diagnosis: A Large Multicenter Comparative Analysis. Clinical Endoscopy, 53(5), 600-610.

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Endoscopic Ultrasound-Guided Fine-Needle Aspiration and Biopsy

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Linear echoendoscope (GF-UCT 180, Olympus Corp., Tokyo, Japan) with an outer diameter of 14.6 mm and channel diameter of 3.7 mm was used in all the cases. The needle used for FNA had calibers 19G/22G/25G (EchoTip Ultra, Cook Medical, Bloomington, Indiana; Expect, Boston Scientific Corp., Marlborough, Massachusetts). The FNB needles included 22G/25G (ProCore, Cook Medical, Bloomington, Indiana; Acquire, Boston Scientific Corp., Marlborough, Massachusetts). The choice of needle caliber and design and method of tissue acquisition was at the discretion of the operating endoscopist. A 19G FNA needle was preferred in pancreatic cystic lesions >2 cm in size.

Nabi Z., Lakhtakia S., Chavan R., Asif S., Basha J., Gupta R., Yarlagadda R., Reddy P.M., Kalapala R, & Reddy D.N. (2021). Diagnostic utility of EUS-guided tissue acquisition in children: A tertiary care center experience. Endoscopic Ultrasound, 10(4), 288-293.

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EUS-Guided Tissue Sampling with Various Needles

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All EUS-guided tissue sampling procedures were performed with a linear array echoendoscope (Olympus GF-UCT180, Olympus, Center Valley, Pa, USA) under deep sedation with monitored anesthesia care by experienced endosonographers or by gastroenterology fellows under direct, expert supervision. Several different needles were used during this period, including 19-gauge, 22-gauge, and 25-gauge FNA needles (Expect, Boston Scientific Corporation, Natick, Mass, USA or Echotip, Cook Medical, Winston-Salem, NC, USA or Beacon, Medtronic Corporation, Newton, Mass, USA) and 19-gauge, 20-gauge, 21-gauge, 22-gauge, and 25-gauge FNB needles (Acquire, Boston Scientific Corporation, Natick, Mass, USA, or SharkCore, Medtronic Corporation, Newton, Mass, USA, or ProCore, Cook Medical, Winston-Salem, NC, USA). Cases in which more than one needle was used were not included in this study to avoid bias. After the lesion was identified and punctured under EUS guidance, a general fanning technique was performed. Individual operator technique varied from each center, including stylet slow-pull technique and standard suction as well as number of to-and-fro movements with each needle pass.

de Moura D.T., McCarty T.R., Jirapinyo P., Ribeiro I.B., Flumignan V.K., Najdawai F., Ryou M., Lee L.S, & Thompson C.C. (2020). EUS-guided fine-needle biopsy versus fine-needle aspiration in the diagnosis of subepithelial lesions: a large multicenter study. Gastrointestinal endoscopy, 92(1), 108-119.e3.

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Retrospective EUS-FNA/FNB Genomic Profiling

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Manual chart review was performed to obtain demographic, clinical, endoscopy, and pathology data. This included age, sex, race, smoking history, family history of pancreatic cancer, pancreatic cancer stage (I/II or III/IV), serum CA 19–9, enrollment in clinical trial, and surgical resection. Procedural information was ascertained through review of endoscopy reports, including the presence or absence of rapid on-site cytology evaluation (ROSE), method of suction (wet or standard), number of needle passes, and intra-procedural or immediate post-procedural complications (aspiration, perforation, bleeding, pancreatitis). Tissue sampling was performed with a 22 gauge FNA needle (EUSN-3, Cook Medical, Winston-Salem NC, USA) or a 22 gauge FNB needle (SharkCore, Medtronic, Minneapolis MN, USA or ProCore, Cook Medical Winston-Salem NC, USA). Of note, at our institution FNB was incorporated as a new technique within the study period. On review of included cases, the decision to use FNA or FNB was made a priori and was not based on patient demographics or tumor characteristics. There were no changes in the pre-determined technique during the procedure. Pathology reports were reviewed to determine the adequacy of EUS samples for genomic testing. Finally, overall survival and mortality data were collected for each patient.

Elhanafi S., Mahmud N., Vergara N., Kochman M.L., Das K.K., Ginsberg G.G., Rajala M, & Chandrasekhara V. (2018). Comparison of Endoscopic Ultrasound Tissue Acquisition Methods for Genomic Analysis of Pancreatic Cancer. Journal of gastroenterology and hepatology, 34(5), 907-913.

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EUS-Guided Biopsy Technique for Lesions

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Linear EUS was used with color and pulsed Doppler to scan the area for vessels. The lesion was then sampled with a 22-gauge reverse beveled needle (ProCore, Cook Medical Inc., Winston-Salem, NC) using the slow capillary suction and fanning techniques with five to 15 to-and-fro movements with each pass. A total of four passes were performed and then the procedure terminated. No cytopathologist was present to review the specimens. If the samples were of insufficient quality as per the impression of the endoscopist (defined as obtaining only tiny fragments, no visible core tissue or it appeared that only blood clot was present), an alternative method (e. g. EUS-FNA, SINK, etc) was performed at the discretion of the endoscopist.

Sanaei O., Fernández-Esparrach G., De La Serna-Higuera C., Carrara S., Kumbhari V., El Zein M.H., Ismail A., Ginès A., Sendino O., Montenegro A., Repici A., Rahal D., Brewer Gutierrez O.I., Moran R., Yang J., Parsa N., Paiji C., Aghaie Meybodi M., Shin E.J., Lennon A.M., Kalloo A.N., Singh V.K., Canto M.I, & Khashab M.A. (2020). EUS-guided 22-gauge fine needle biopsy versus single-incision with needle knife for the diagnosis of upper gastrointestinal subepithelial lesions: a randomized controlled trial. Endoscopy International Open, 8(3), E266-E273.

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EUS-Guided Tissue Sampling Techniques

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All EUS-guided tissue sampling procedures were performed with a linear array echoendoscope (Olympus GF-UCT180, Olympus, Center Valley, Pennsylvania, United States) under monitored anesthesia care by experienced endosonographers or by fellows under expert supervision. Several different needles were used during these period, including 19G, 22G, and 25G FNA needles (Expect, Boston Scientific Corporation, Natick, MA, USA or Echotip, Wilson-Cook Medical, Winston-Salem, North Carolina, United States or Beacon, Medtronic Corporation, Newton, Massachusetts, United States) and 19G, 20G, 21G, 22G, and 25G FNB needles (Acquire, Boston Scientific Corporation, Natick, Massachusetts, United States or SharkCore, Medtronic Corporation, Newton, Massachusetts, United States or ProCore, Cook Medical, Winston-Salem, North Carolina, United States). After the lesion was identified and punctured under EUS guidance, a general fanning technique was performed. Individual operator technique varied from each center, including stylet slow-pull technique and standard suction.

de Moura D.T., McCarty T.R., Jirapinyo P., Ribeiro I.B., Hathorn K.E., Madruga-Neto A.C., Lee L.S, & Thompson C.C. (2020). Evaluation of endoscopic ultrasound fine-needle aspiration versus fine-needle biopsy and impact of rapid on-site evaluation for pancreatic masses. Endoscopy International Open, 8(6), E738-E747.

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EUS-Guided Tissue Sampling in Patients with Pancreatic Masses and Biliary Stents

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Randomized controlled trials (RCTs) and/or observational cohort studies meeting the following inclusion criteria were included: (a) patients > 18 years with solid pancreatic head masses and jaundice; (b) intervention: EUS-guided tissue sampling through side-fenestrated FNB (ProCore^®, Cook Medical Inc., Bloomington, IN, USA), end-cutting FNB (Franseen needle (Acquire^®, Boston Scientific, Marlborough, MA, USA) or Fork-tip needle (SharkCore^®, Medtronic, Dublin, Ireland)) or FNA in patients with plastic or metal biliary stents; (c) comparator: EUS-TA through side-fenestrated FNB, end-cutting FNB or FNA in patients without biliary stents; and (d) outcomes: primary outcome was diagnostic accuracy, whereas secondary outcomes were overall pooled sample adequacy, diagnostic sensitivity, specificity and mean number of needle passes. Additionally, safety data, including adverse events, were also analyzed.
Our exclusion criteria were as follows: (a) single-arm cohort studies without a comparator, (b) studies not reporting subgroup analysis restricted to patients with biliary stents, and (c) studies not reporting our primary and secondary outcomes of interest.

Facciorusso A., Chandan S., Gkolfakis P., Ramai D., Mohan B.P., Lisotti A., Conti Bellocchi M.C., Papanikolaou I.S., Mangiavillano B., Triantafyllou K., Manthopoulou E., Mare R., Fusaroli P, & Crinò S.F. (2023). Do Biliary Stents Affect EUS-Guided Tissue Acquisition (EUS-TA) in Solid Pancreatic Lesions Determining Biliary Obstruction? A Literature Review with Meta-Analysis. Cancers, 15(6), 1789.

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