Comparison of 22-gauge standard and Franseen needles in EUS-guided tissue acquisition for diagnosing solid pancreatic lesions: a multicenter randomized controlled trial.

Endoscopic Ultrasound-Guided Fine Needle Aspiration / methods Endosonography Humans Needles Pancreas / diagnostic imaging Pancreatic Neoplasms / diagnosis

Journal

Gastrointestinal endoscopy
ISSN: 1097-6779
Titre abrégé: Gastrointest Endosc
Pays: United States
ID NLM: 0010505

Informations de publication

Date de publication:
07 2022
Historique:
received: 21 10 2021
accepted: 01 02 2022
pubmed: 14 2 2022
medline: 22 6 2022
entrez: 13 2 2022
Statut: ppublish

Résumé

This large multicenter randomized controlled trial compared the diagnostic yields of 22-gauge standard and 22-gauge Franseen needles for EUS-guided tissue acquisition (EUS-TA) of solid pancreatic lesions. Consecutive patients with solid pancreatic lesions were prospectively randomized to EUS-TA using standard or Franseen needles. Samples obtained with the first needle pass and with second and subsequent passes were evaluated separately. The primary endpoint was the rate of accuracy for diagnosis of malignancy. Other endpoints were technical success rate, sample cellularity, adverse events, diagnostic accuracy in patient subgroups, and the diagnostic accuracy and numbers of second and subsequent needle passes. Of 523 patients undergoing EUS-TA, 260 were randomized to using standard 22-gauge needles and 263 to 22-gauge Franseen needles. The technical success rate in each group was 99.6%, with similar adverse event rates in the standard (1.5%) and Franseen (.8%) needle groups. First-pass EUS-TA using the Franseen needle resulted in significantly greater diagnostic accuracy (84.0% vs 71.2%, P < .001) and sensitivity (82.4% vs 66.7%, P < .001) than first-pass EUS-TA using a standard needle and also resulted in superior diagnostic accuracy in patients requiring immunostaining. Second and subsequent EUS-TA using Franseen needles showed significantly greater accuracy (94.7% vs 90.0%, P = .049) and sensitivity (94.0% vs 88.6%, P = .047) and required fewer needle passes (1.81 vs 2.03, P = .008) than using standard needles. EUS-TA with the Franseen needle is superior to EUS-TA with a standard needle with respect to diagnostic accuracy per pass, particularly in patients who require immunostaining, and number of passes when using macroscopic on-site evaluation. (Clinical trial registration numbers: UMIN000030634 and jRCTs052180062.).

Sections du résumé

BACKGROUND AND AIMS
This large multicenter randomized controlled trial compared the diagnostic yields of 22-gauge standard and 22-gauge Franseen needles for EUS-guided tissue acquisition (EUS-TA) of solid pancreatic lesions.
METHODS
Consecutive patients with solid pancreatic lesions were prospectively randomized to EUS-TA using standard or Franseen needles. Samples obtained with the first needle pass and with second and subsequent passes were evaluated separately. The primary endpoint was the rate of accuracy for diagnosis of malignancy. Other endpoints were technical success rate, sample cellularity, adverse events, diagnostic accuracy in patient subgroups, and the diagnostic accuracy and numbers of second and subsequent needle passes.
RESULTS
Of 523 patients undergoing EUS-TA, 260 were randomized to using standard 22-gauge needles and 263 to 22-gauge Franseen needles. The technical success rate in each group was 99.6%, with similar adverse event rates in the standard (1.5%) and Franseen (.8%) needle groups. First-pass EUS-TA using the Franseen needle resulted in significantly greater diagnostic accuracy (84.0% vs 71.2%, P < .001) and sensitivity (82.4% vs 66.7%, P < .001) than first-pass EUS-TA using a standard needle and also resulted in superior diagnostic accuracy in patients requiring immunostaining. Second and subsequent EUS-TA using Franseen needles showed significantly greater accuracy (94.7% vs 90.0%, P = .049) and sensitivity (94.0% vs 88.6%, P = .047) and required fewer needle passes (1.81 vs 2.03, P = .008) than using standard needles.
CONCLUSIONS
EUS-TA with the Franseen needle is superior to EUS-TA with a standard needle with respect to diagnostic accuracy per pass, particularly in patients who require immunostaining, and number of passes when using macroscopic on-site evaluation. (Clinical trial registration numbers: UMIN000030634 and jRCTs052180062.).

Identifiants

DOI: 10.1016/j.gie.2022.02.005 PMID: 35151711
pubmed: 35151711
pii: S0016-5107(22)00099-2
doi: 10.1016/j.gie.2022.02.005
pii:
doi:

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

57-66.e2

Informations de copyright

Copyright © 2022 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Auteurs

Masahiro Itonaga (M)

Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.

Satoru Yasukawa (S)

Department of Pathology, Kyoto Second Red Cross Hospital, Kyoto, Japan Department of Surgical Pathology, Kyoto Prefectural University of Medicine, Kyoto, Japan.

Nobuyasu Fukutake (N)

Department of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan.

Takeshi Ogura (T)

The Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan.

Masanori Asada (M)

Department of Gastroenterology and Hepatology, Japanese Red Cross Osaka Hospital, Osaka, Japan.

Toshio Shimokawa (T)

Clinical Study Support Center, Wakayama Medical University, Wakayama, Japan.

Osamu Inatomi (O)

Division of Gastroenterology, Department of Medicine, Shiga University of Medical Science, Shiga, Japan.

Yoshitaka Nakai (Y)

Digestive Disease Center, Department of Gastroenterology & Hepatology, Kyoto Katsura Hospital, Kyoto, Japan.

Hideyuki Shiomi (H)

Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.

Hiroko Nebiki (H)

Department of Gastroenterology, Osaka City General Hospital, Osaka, Japan.

Azumi Suzuki (A)

Department of Gastroenterology, Kyoto Second Red Cross Hospital, Kyoto, Japan.

Koh Kitagawa (K)

Department of Gastroenterology, Nara Medical University, Nara, Japan.

Satoshi Asai (S)

Department of Gastroenterology, Tane General Hospital, Osaka, Japan.

Masaaki Shimatani (M)

Division of Gastroenterology and Hepatology, The Third Department of Internal Medicine, Kansai Medical University, Osaka, Japan.

Tsuyoshi Sanuki (T)

Department of Gastroenterology, Kita-harima Medical Center, Hyogo, Japan.

Akira Kurita (A)

Department of Gastroenterology and Hepatology, Kitano Hospital, Tazuke Kofukai Medical Research Institute, Osaka, Japan.

Mamoru Takenaka (M)

Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.

Motoyuki Yoshida (M)

Department of Gastroenterology, Nara Prefecture Western Medical Center, Nara, Japan.

Noriyuki Hoki (N)

Department of Gastroenterology, Bellland General Hospital, Sakai, Japan.

Hiroaki Yasuda (H)

Department of Medicine, Division of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.

Hirotsugu Maruyama (H)

Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan.

Hisakazu Matsumoto (H)

Department of Gastroenterology and Hepatology, Japanese Red Cross Society of Wakayama Medical Center, Wakayama, Japan.

Akio Yanagisawa (A)

Department of Pathology, Japanese Red Cross Society Kyoto Daiichi Hospital, Kyoto, Japan Department of Surgical Pathology, Kyoto Prefectural University of Medicine, Kyoto, Japan.

Masayuki Kitano (M)

Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.

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Classifications MeSH

questionsmedicales.fr › Techniques d'investigation › Techniques cytologiques › Cytodiagnostic › Biopsie › Biopsie guidée par l'image › Cytoponction sous échoendoscopie › Comparison of 22-gauge standard and Franseen...
questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Imagerie diagnostique › Échographie › Endosonographie › Comparison of 22-gauge standard and Franseen...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Comparison of 22-gauge standard and Franseen...
questionsmedicales.fr › Équipement et fournitures › Aiguilles › Comparison of 22-gauge standard and Franseen...
questionsmedicales.fr › Système digestif › Pancréas › Comparison of 22-gauge standard and Franseen...
questionsmedicales.fr › Maladies endocriniennes › Tumeurs des glandes endocrines › Tumeurs du pancréas › Comparison of 22-gauge standard and Franseen...