Comparation Between Needles for EUS-guided Sampling of Solid Pancreatic Lesions

NCT04877340 | Unknown DMC

• 1 other identifier: 26962419.3.0000.0065
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized study in order to compare the diagnostic yield (primary outcome) of EUS-guided sampling of pancreatic solid lesions obtained with the 25-gauge Franseen and the 25-gauge standard needle in patients undergoing EUS-guided sampling of pancreatic solid masses without ROSE. Secondary outcomes are the number of extra passes with each needle required to reach adequate core, possibility to perform immunohistochemistry and the adverse event rate.

Conditions

Pancreatic Neoplasms

Keywords

accuracy; pancreatic cancer; endoscopic ultrasound-guided

Outcome Measures

Primary Outcomes (1)

• Compare the diagnostic yield

  compare the diagnostic yield between two EUS needles

  2 years

Secondary Outcomes (3)

• extra passes with each needle

  2 years

• perform immunohistochemistry

  2 years

• adverse event rate

  2 years

Study Arms (2)

Standard FNA 22G needle

OTHER

The pancreatic mass will be puncture, for expert endoscopist, with a standard FNA 22G needle

Device: needle punction

Franseen 22G needle

EXPERIMENTAL

The pancreatic mass will be puncture, for expert endoscopist, with a FNB 22G needle. The sequence of the use of needles will be randomized.

Device: needle punction

Interventions

needle punction DEVICE

EUS-guided sampling of pancreatic solid lesions obtained with the 22-gauge

Franseen 22G needle; Standard FNA 22G needle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- solid pancreatic lesion larger than 15 mm

You may not qualify if:

• pancreatic cystic lesion
• lesion not detected in EUS
• abnormal coagulation parameters (INR\> 2, platelet count \< 50,000)

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

ICESP

São Paulo, São Paulo, 01246-000, Brazil

RECRUITING

Related Publications (14)

• Madhoun MF, Wani SB, Rastogi A, Early D, Gaddam S, Tierney WM, Maple JT. The diagnostic accuracy of 22-gauge and 25-gauge needles in endoscopic ultrasound-guided fine needle aspiration of solid pancreatic lesions: a meta-analysis. Endoscopy. 2013;45(2):86-92. doi: 10.1055/s-0032-1325992. Epub 2013 Jan 10.

  PMID: 23307148 BACKGROUND

• Puri R, Vilmann P, Saftoiu A, Skov BG, Linnemann D, Hassan H, Garcia ES, Gorunescu F. Randomized controlled trial of endoscopic ultrasound-guided fine-needle sampling with or without suction for better cytological diagnosis. Scand J Gastroenterol. 2009;44(4):499-504. doi: 10.1080/00365520802647392.

  PMID: 19117242 BACKGROUND

• Wani S, Early D, Kunkel J, Leathersich A, Hovis CE, Hollander TG, Kohlmeier C, Zelenka C, Azar R, Edmundowicz S, Collins B, Liu J, Hall M, Mullady D. Diagnostic yield of malignancy during EUS-guided FNA of solid lesions with and without a stylet: a prospective, single blind, randomized, controlled trial. Gastrointest Endosc. 2012 Aug;76(2):328-35. doi: 10.1016/j.gie.2012.03.1395. Epub 2012 Jun 12.

  PMID: 22695205 BACKGROUND

• Itoi T, Sofuni A, Itokawa F, Irisawa A, Khor CJ, Rerknimitr R. Current status of diagnostic endoscopic ultrasonography in the evaluation of pancreatic mass lesions. Dig Endosc. 2011 May;23 Suppl 1:17-21. doi: 10.1111/j.1443-1661.2011.01132.x.

  PMID: 21535194 BACKGROUND

• Levy MJ. Endoscopic ultrasound-guided trucut biopsy of the pancreas: prospects and problems. Pancreatology. 2007;7(2-3):163-6. doi: 10.1159/000104240. Epub 2007 Jun 21.

  PMID: 17592229 BACKGROUND

• Fabbri C, Polifemo AM, Luigiano C, Cennamo V, Baccarini P, Collina G, Fornelli A, Macchia S, Zanini N, Jovine E, Fiscaletti M, Alibrandi A, D'Imperio N. Endoscopic ultrasound-guided fine needle aspiration with 22- and 25-gauge needles in solid pancreatic masses: a prospective comparative study with randomisation of needle sequence. Dig Liver Dis. 2011 Aug;43(8):647-52. doi: 10.1016/j.dld.2011.04.005. Epub 2011 May 17.

  PMID: 21592873 BACKGROUND

• Wang Y, Chen Q, Wang J, Wu X, Duan Y, Yin P, Guo Q, Hou W, Cheng B. Comparison of modified wet suction technique and dry suction technique in endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) for solid lesions: study protocol for a randomized controlled trial. Trials. 2018 Jan 17;19(1):45. doi: 10.1186/s13063-017-2380-y.

  PMID: 29343303 BACKGROUND

• Kim HJ, Jung YS, Park JH, Park DI, Cho YK, Sohn CI, Jeon WK, Kim BI, Choi KY, Ryu S. Endosonographer's macroscopic evaluation of EUS-FNAB specimens after interactive cytopathologic training: a single-center prospective validation cohort study. Surg Endosc. 2016 Oct;30(10):4184-92. doi: 10.1007/s00464-015-4727-3. Epub 2016 Jan 7.

  PMID: 26743106 BACKGROUND

• Sadaf S, Loya A, Akhtar N, Yusuf MA. Role of endoscopic ultrasound-guided-fine needle aspiration biopsy in the diagnosis of lymphoma of the pancreas: A clinicopathological study of nine cases. Cytopathology. 2017 Dec;28(6):536-541. doi: 10.1111/cyt.12442. Epub 2017 Jul 24.

  PMID: 28737285 BACKGROUND

• Mohanty SK, Pradhan D, Sharma S, Sharma A, Patnaik N, Feuerman M, Bonasara R, Boyd A, Friedel D, Stavropoulos S, Gupta M. Endoscopic ultrasound guided fine-needle aspiration: What variables influence diagnostic yield? Diagn Cytopathol. 2018 Apr;46(4):293-298. doi: 10.1002/dc.23883. Epub 2017 Dec 27.

  PMID: 29280329 BACKGROUND

• 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.

  PMID: 1568614 RESULT

• Iglesias-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.

  PMID: 21483464 RESULT

• Iglesias-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.

  PMID: 21420083 RESULT

• Bang JY, Hebert-Magee S, Hasan MK, Navaneethan U, Hawes R, Varadarajulu S. Endoscopic ultrasonography-guided biopsy using a Franseen needle design: Initial assessment. Dig Endosc. 2017 May;29(3):338-346. doi: 10.1111/den.12769. Epub 2016 Dec 20.

  PMID: 27878861 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• FAUZE MALUF-FILHO, PHD

  ICESP/FMUSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

FAUZE MALUF-FILHO, PHD

CONTACT

+55 (11)38932000; fauze.maluf@terra.om.br

GABRIELA PADUANI, MD

CONTACT

+55(11)944605119; gabrielapaduani@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: May 7, 2021
• Study Start: November 26, 2020
• Primary Completion: November 1, 2022
• Study Completion: April 1, 2023
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)