CC BY-NC-ND 4.0 · Endosc Int Open 2020; 08(03): E266-E273
DOI: 10.1055/a-1075-1900
Original article
Owner and Copyright © Georg Thieme Verlag KG 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

Omid Sanaei*
1  Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institution, Baltimore, Maryland, United States
,
Glòria Fernández-Esparrach*
2  Endoscopy Unit, Gastroenterology Department, ICMDiM, Hospital Clinic, University of Barcelona, Catalonia, Spain
3  Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
4  Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Barcelona, Spain
,
Carlos De La Serna-Higuera
5  Gastroenterology Department, Hospital Universitario Rio Hortega, Valladolid, Spain
,
Silvia Carrara
6  Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Clinical and Research Center – IRCCS, Rozzano, Italy
,
Vivek Kumbhari
1  Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institution, Baltimore, Maryland, United States
,
Mohamad H. El Zein
1  Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institution, Baltimore, Maryland, United States
,
Amr Ismail
1  Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institution, Baltimore, Maryland, United States
,
Angels Ginès
2  Endoscopy Unit, Gastroenterology Department, ICMDiM, Hospital Clinic, University of Barcelona, Catalonia, Spain
3  Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
4  Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Barcelona, Spain
,
Oriol Sendino
2  Endoscopy Unit, Gastroenterology Department, ICMDiM, Hospital Clinic, University of Barcelona, Catalonia, Spain
3  Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain
4  Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Barcelona, Spain
,
Andrea Montenegro
2  Endoscopy Unit, Gastroenterology Department, ICMDiM, Hospital Clinic, University of Barcelona, Catalonia, Spain
,
Alessandro Repici
6  Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Clinical and Research Center – IRCCS, Rozzano, Italy
,
Daoud Rahal
7  Department of Pathology, Humanitas Clinical and Research Center, Rozzano, Italy
,
Olaya I. Brewer Gutierrez
1  Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institution, Baltimore, Maryland, United States
,
Robert Moran
1  Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institution, Baltimore, Maryland, United States
,
Juliana Yang
1  Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institution, Baltimore, Maryland, United States
,
Nasim Parsa
1  Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institution, Baltimore, Maryland, United States
,
Christopher Paiji
1  Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institution, Baltimore, Maryland, United States
,
Mohamad Aghaie Meybodi
1  Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institution, Baltimore, Maryland, United States
,
Eun Ji Shin
1  Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institution, Baltimore, Maryland, United States
,
Anne Marie Lennon
1  Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institution, Baltimore, Maryland, United States
,
Anthony N. Kalloo
1  Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institution, Baltimore, Maryland, United States
,
Vikesh K. Singh
1  Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institution, Baltimore, Maryland, United States
,
Marcia Irene Canto
1  Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institution, Baltimore, Maryland, United States
,
Mouen A. Khashab
1  Division of Gastroenterology and Hepatology, Johns Hopkins Medical Institution, Baltimore, Maryland, United States
› Author Affiliations
Further Information

Publication History

submitted 06 September 2019

accepted after revision 18 November 2019

Publication Date:
21 February 2020 (online)

Abstract

Background and study aims EUS-FNA has suboptimal accuracy in diagnosing gastrointestinal subepithelial tumors (SETs). EUS-guided 22-gauge fine needle biopsy (EUS-FNB) and single-incision with needle knife (SINK) were proposed to increase accuracy of diagnosis. This study aimed to prospectively compare the diagnostic accuracy and safety of EUS-FNB with SINK in patients with upper gastrointestinal SETs.

Patients and methods All adult patients referred for EUS evaluation of upper gastrointestinal SETs ≥ 15 mm in size were eligible for inclusion. Patients were randomized to undergo EUS-FNB or SINK. Lesions were sampled with a 22-gauge reverse beveled core needle in the EUS-FNB group and by a conventional needle-knife sphincterotome and biopsy forceps in the SINK group. Patients were blinded to the technique used. The primary outcome was diagnostic accuracy. Secondary outcomes included adverse events, histological yield and procedure duration. Study enrollment was terminated early due to poor recruitment.

Results A total of 56 patients (31 male (55.37 %); mean age, 67.41 ± 12.70 years) were randomized to either EUS-FNB (n = 26) or SINK (n = 30). Technical success was 96.15 % and 96.66 %, respectively. The majority of lesions were gastrointestinal stromal tumors (51.78 %). No significant difference was found between EUS-FNB and SINK in terms of diagnostic accuracy for a malignant or benign disease (76 % vs. 89.28 %, respectively; P = 0.278). The rate of adverse events (none severe) was also comparable (7.69 % vs. 10 %, respectively; P = 1.0) including two abdominal pain episodes in the EUS-FNB group compared to two delayed bleeding (one requiring hospitalization and radiologic embolization) and 1 abdominal pain in the SINK group.

Conclusion EUS-FNB and SINK are equally effective techniques for upper gastrointestinal SETs sampling. SINK can be associated with mild to moderate delayed bleeding.

* Drs. Sanaei and Fernández-Esparrach contributed equally.