Endoscopic Ultrasonography (EUS) Guided Fine Needle Aspiration Using Free Stylet 22g and 25 g Needles

NCT01543282 | Completed DMC

• 1 other identifier: CE 11.150
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled study comparing EUS-FNA with 22 gauge and 25 gauge needles in consecutive patients. Summary Background: three needle sizes for endoscopic ultrasonography guided fine needle aspiration (EUS-FNA) are currently available: 22 Gauge (G), 25 G and 19 G. However, well design studies comparing them regarding efficacy and feasibility are lacking. Aims: to investigate diagnostic yield, specimen adequacy, feasibility and complications of the conventional 22 G compared with the 25 G needle. Methods: patients ≥ 18 years, referred to EUS-FNA for a solid lesion will be considered for inclusion. Patients with suspected diagnosis of lymphoma, GIST, sarcoidosis, significant coagulopathy (APT \< 50% or platelets \< 50000/mm3), use of warfarin or other anticoagulants, use of clopidogrel within 7 days of EUS, inability or refusal to sign the informed consent and pregnancy or suspected pregnancy will be excluded. Participants will be randomized to 22 G needle and 25 G FNA. Chi-square test will be used to compare proportions. Continuous variables will be compared using Student´s t test. A two-tailed P values of less than 0.05 will be considered statistically significant. The diagnostic yield of 25 G and 22 G needle will be evaluated by four criteria: sensitivity, specificity, positive predictive value and negative predictive value. An expected rate of 85% diagnostic yield from EUS guided FNA by using 22G needle will be considered. By using a power of 80% and an α value of 0.05 would be necessary 120 patients per group to detect a 15% difference in the rate of diagnostic yield.

Conditions

Solid Neoplasms

Keywords

endoscopic ultrasonography; fine needle aspiration cytology; 22 gauge; 25 gauge

Outcome Measures

Primary Outcomes (1)

• Accuracy of stylet-free, solid lesion EUS-FNA using the 22 G FNA vs the 25 G FNA needle, in consecutive patients referred to EUS-FNA.

  6 months

Secondary Outcomes (1)

• Specimen adequacy, number of FNA passes, ease of puncture, failure of the FNA needle and complications

  6 months

Study Arms (2)

EUS 22 gauge needle

ACTIVE COMPARATOR

EUS 22 g needle is the most common needle used in clinical practice. EUS-FNA passes will be performed without stylet until sample adequacy or until a maximum of 5 FNA passes in pancreatic lesions or 3 FNA passes in other lesions. In case of inadequate sample after 3 passes, or needle failure, cross over to the other type of needle is allowed.

Device: Endosonography guided fine needle aspiration cytology ( Cook Medical, Boston Scientific)

EUS 25 gauge needle

EXPERIMENTAL

25 gauge needle is usually used less frequently but nowadays is increasingly used and is as well a valid option. EUS-FNA passes will be performed without stylet until sample adequacy or until a maximum of 5 FNA passes in pancreatic lesions or 3 FNA passes in other lesions. In case of inadequate sample after 3 passes, or needle failure, cross over to the other type of needle is allowed.

Device: Endosonography guided fine needle aspiration cytology ( Cook Medical, Boston Scientific)

Interventions

Endosonography guided fine needle aspiration cytology ( Cook Medical, Boston Scientific) DEVICE

Patients will be randomized either to receive EUS-FNA with a 22 g needle or 25 g needle. EUS-FNA passes will be performed without stylet until sample adequacy or until a maximum of 5 FNA passes in pancreatic lesions or 3 FNA passes in other lesions. In case of inadequate sample after 3 passes, or needle failure, cross over to the other type of needle is allowed.

Also known as: Cook Medical, Boston Scientific

EUS 22 gauge needle; EUS 25 gauge needle

Eligibility Criteria

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

You may qualify if:

• Consecutive patients referred for EUS-FNA of a solid lesion.

You may not qualify if:

• Age \< 18 years
• Patients with suspected diagnosis of lymphoma, GIST, sarcoidosis or other lesions in which a large amount of tissue will be required for diagnosis
• Significant coagulopathy (INR \> 1.5, platelets \< 50000/mm3
• Use of low molecular weight heparin, use of clopidogrel within 7 days of EUS)
• Cystic lesions
• Inability or refusal to sign the informed consent

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator

Study Sites (1)

Hopital Saint Luc (Centre Hopitalier de l´Université du Montreal)

Montreal, Quebec, H2X3J4, Canada

Location

Related Publications (7)

• Yusuf TE, Ho S, Pavey DA, Michael H, Gress FG. Retrospective analysis of the utility of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) in pancreatic masses, using a 22-gauge or 25-gauge needle system: a multicenter experience. Endoscopy. 2009 May;41(5):445-8. doi: 10.1055/s-0029-1214643. Epub 2009 May 5.

  PMID: 19418399 RESULT

• Imazu H, Uchiyama Y, Kakutani H, Ikeda K, Sumiyama K, Kaise M, Omar S, Ang TL, Tajiri H. A prospective comparison of EUS-guided FNA using 25-gauge and 22-gauge needles. Gastroenterol Res Pract. 2009;2009:546390. doi: 10.1155/2009/546390. Epub 2009 Nov 17.

  PMID: 19997511 RESULT

• Lee JH, Stewart J, Ross WA, Anandasabapathy S, Xiao L, Staerkel G. Blinded prospective comparison of the performance of 22-gauge and 25-gauge needles in endoscopic ultrasound-guided fine needle aspiration of the pancreas and peri-pancreatic lesions. Dig Dis Sci. 2009 Oct;54(10):2274-81. doi: 10.1007/s10620-009-0906-1. Epub 2009 Aug 11.

  PMID: 19669880 RESULT

• Sakamoto H, Kitano M, Komaki T, Noda K, Chikugo T, Dote K, Takeyama Y, Das K, Yamao K, Kudo M. Prospective comparative study of the EUS guided 25-gauge FNA needle with the 19-gauge Trucut needle and 22-gauge FNA needle in patients with solid pancreatic masses. J Gastroenterol Hepatol. 2009 Mar;24(3):384-90. doi: 10.1111/j.1440-1746.2008.05636.x. Epub 2008 Nov 20.

  PMID: 19032453 RESULT

• Camellini 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.

  PMID: 21611946 RESULT

• 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 RESULT

• Wani S, Gupta N, Gaddam S, Singh V, Ulusarac O, Romanas M, Bansal A, Sharma P, Olyaee MS, Rastogi A. A comparative study of endoscopic ultrasound guided fine needle aspiration with and without a stylet. Dig Dis Sci. 2011 Aug;56(8):2409-14. doi: 10.1007/s10620-011-1608-z. Epub 2011 Feb 17.

  PMID: 21327919 RESULT

Study Officials

• Anand V Sahai, MD

  Hopital Saint Luc (Centre Hopitalier de l´Université du Montreal) Montreal, Quebec, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: March 2, 2012
• Study Start: December 10, 2011
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: May 22, 2020

Record last verified: 2020-05

Locations

CA (1)