Solid Neoplasms Clinical Trial
Official title:
Randomized Controlled Study Comparing Endoscopic Ultrasonography Guided Fine Needle Aspiration Using Free Stylet 22g and 25 g Needles in Solid Lesions
NCT number | NCT01543282 |
Other study ID # | CE 11.150 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 10, 2011 |
Est. completion date | July 2017 |
Verified date | May 2020 |
Source | Centre hospitalier de l'Université de Montréal (CHUM) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | July 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Consecutive patients referred for EUS-FNA of a solid lesion. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Hopital Saint Luc (Centre Hopitalier de l´Université du Montreal) | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) | Centre de Recherche du Centre Hospitalier de l'Université de Montréal |
Canada,
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-ne — View Citation
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 — View Citation
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. — View Citation
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 D — View Citation
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 ma — View Citation
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/s1 — View Citation
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. 20 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Specimen adequacy, number of FNA passes, ease of puncture, failure of the FNA needle and complications | 6 months |
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