Management of small subepithelial tumors by endoscopic banding without resection and single-incision needle-knife-assisted biopsy sampling: a prospective multicenter study.

Autor: Bas-Cutrina F; Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Barcelona, Spain; Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain; Department of Clinical Sciences, School of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain; Digestive Diseases Unit, Hospital General de Granollers, Barcelona, Spain., Loras C; Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari Mútua de Terrassa, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain; Faculty of Health Sciences, Universitat Oberta de Catalunya, Barcelona, Spain., Pardo A; Department of Digestive Diseases, Hospital Universitari Joan XXIII, Tarragona, Spain., Ballester-Clau R; Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari Arnau de Vilanova, Lleida, Spain., Huertas C; Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari Doctor Josep Trueta, Girona, Spain., Guarner-Argente C; Endoscopy Unit, Digestive Pathology Service, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain., Colan-Hernandez J; Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain., Consiglieri CF; Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Barcelona, Spain; Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain; Department of Clinical Sciences, School of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain., Andujar X; Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari Mútua de Terrassa, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain., Vilanova-Serra M; Department of Digestive Diseases, Hospital Universitari Joan XXIII, Tarragona, Spain., González-Huix F; Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari Arnau de Vilanova, Lleida, Spain., Pardo-Grau L; Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari Doctor Josep Trueta, Girona, Spain., Maisterra S; Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Barcelona, Spain; Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain; Department of Clinical Sciences, School of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain., Ruiz-Ramírez P; Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari Mútua de Terrassa, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain., Garcia-Sumalla A; Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Barcelona, Spain; Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain; Department of Clinical Sciences, School of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain., Tebé C; Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain; Statistics Advisory Service, Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain., Videla S; Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain; Department of Clinical Sciences, School of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain; Clinical Research and Clinical Trial Unit (UICEC-IDIBELL), Hospital Universitari de Bellvitge, Barcelona, Spain., Gornals JB; Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Barcelona, Spain; Bellvitge Biomedical Research Institute (IDIBELL), Barcelona, Spain; Department of Clinical Sciences, School of Medicine and Health Sciences, University of Barcelona, Barcelona, Spain; Faculty of Health Sciences, Universitat Oberta de Catalunya, Barcelona, Spain.
Jazyk: angličtina
Zdroj: Gastrointestinal endoscopy [Gastrointest Endosc] 2023 Dec; Vol. 98 (6), pp. 911-921.e8. Date of Electronic Publication: 2023 May 30.
DOI: 10.1016/j.gie.2023.05.057
Abstrakt: Background and Aims: Endoscopic band ligation (EBL) without resection combined with single-incision needle-knife (SINK) biopsy sampling may have a positive impact on small GI subepithelial tumor (SET) management, but the method needs to be tested. The aim was to evaluate the feasibility of this strategy in small-sized SETs.
Methods: This prospective multicenter observational cohort study in 7 centers included patients with SETs ≤15 mm (confirmed by EUS) between March 2017 and March 2020. The primary outcome was clinical success at 4 weeks, defined as complete SET disappearance on EUS. Secondary outcomes were long-term (1-year) clinical success, technical difficulty level, clinical impact, yield pathology, and safety.
Results: Of 273 patients screened, 122 (62.3% women; mean age, 60.9 ± 13.2 years) were included with SETs (mean size, 9 ± 2.8 mm; gastric location, 77%; superficial layer dependence, 63%). The primary endpoint was achieved in 73.6% of patients (95% confidence interval [CI], 64.8-81.2). At the 1-year follow-up, the success rate was 68.4% (95% CI, 59.1-76.8). A favorable clinical impact was observed in 97 cases (79.5%; 95% CI, 71.3-86.3). Pathology diagnosis was known in 70%. Potentially malignant lesions were present in 24.7%. The related adverse events rate was 4.1% (95% CI, 1.3-9.3; all mild: 2 bleeding, 2 abdominal pain). On multivariable analysis, the ≤10-mm SET group was associated with a greater success rate (1 year, 87%; relative risk, 5.07; 95% CI, 2.63-9.8) and clinical impact rate (92.7%; relative risk, 6.15; 95% CI, 2.72-13.93).
Conclusions: EBL plus SINK biopsy sampling seems to be feasible and safe, and it may offer a favorable clinical impact in small-sized SETs. In particular, SETs ≤10 mm are the best candidates. (Clinical trial registration number: NCT03247231.).
(Copyright © 2023 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE