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International multicenter comprehensive analysis of adverse events associated with lumen-apposing metal stent placement for pancreatic fluid collection drainage - 29/02/20

Doi : 10.1016/j.gie.2019.11.021 
Alessandro Fugazza, MD 1, , Amrita Sethi, MD 2, Arvind J. Trindade, MD 3, Edoardo Troncone, MD 4, John Devlin, MD 5, Mouen A. Khashab, MD 6, Frank P. Vleggaar, MD, PhD 7, Auke Bogte, MD, PhD 7, Ilaria Tarantino, MD 8, Pierre H. Deprez, MD, PhD 9, Carlo Fabbri, MD 10, José Ramón Aparicio, MD 11, Paul Fockens, MD PhD 12, Rogier P. Voermans, MD, PhD 12, Will Uwe, MD 13, Geoffroy Vanbiervliet, MD 14, Antoine Charachon, MD 15, Christopher D. Packey, MD, PhD 2, Petros C. Benias, MD 3, Yasser El-Sherif, MD 5, Christopher Paiji, MD 6, Dario Ligresti, MD 8, Cecilia Binda, MD 10, Belén Martínez, MD 11, Loredana Correale, PhD 1, Douglas G. Adler, MD, FACG, AGAF, FASGE 16, Alessandro Repici, MD 1, 17, Andrea Anderloni, MD, PhD 1
1 Digestive Endoscopy Unit, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Italy 
2 Division of Digestive and Liver Disease, Columbia University Medical Center-NYPH, New York, New York, USA 
3 Division of Gastroenterology, Long Island Jewish Medical Center, Zucker School of Medicine at Hofstra/Northwell, Northwell Health System, New Hyde Park, New York, USA 
4 Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy 
5 Institute of Liver Studies, Kings College Hospital, London, UK 
6 Therapeutic Endoscopy, Division of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore, Maryland, USA 
7 Department of Gastroenterology and Hepatology, University Medical Center, Utrecht, Netherlands 
8 Endoscopy Service, Department of Diagnostic and Therapeutic Services, IRCCS-ISMETT, Palermo, Italy 
9 Department of Hepatogastroenterology, Cliniques universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium 
10 Unit of Gastroenterology and Digestive Endoscopy, Forlì-Cesena Hospitals, AUSL, Romagna, Italy 
11 Endoscopy Unit, Digestive Service, Alicante University General Hospital, Alicante, Spain 
12 Department of Gastroenterology & Hepatology, Amsterdam University Medical Centers AMC, Amsterdam, Netherlands 
13 Department of Gastroenterology, Municipal Hospital, Gera, Germany 
14 Digestive Endoscopy Unit, l'Archet University Hospital, Nice, France 
15 Service d'Hépato-gastro-entérologie, CH Princesse Grace, Monaco 
16 Division of Gastroenterology and Hepatology, University of Utah School of Medicine, Salt Lake City, Utah, USA 
17 Humanitas University, Rozzano, Italy 

Reprint requests: Alessandro Fugazza, MD, Digestive Endoscopy Unit, Departement of Gastroenterology, Humanitas Research Hospital, Rozzano(MI), Italy.Digestive Endoscopy UnitDepartement of GastroenterologyHumanitas Research HospitalRozzano(MI)Italy

Abstract

Background and Aims

High rates of technical and clinical success were reported for lumen-apposing metal stent (LAMS) placement for peripancreatic fluid collection (PFC) drainage. However, data on the adverse event (AE) rates are heterogeneous. The aim of this study was to evaluate the incidence, severity, management, and risk factors of AEs related to the use of LAMSs for drainage of PFCs in a large cohort of patients.

Methods

This is a multicenter, international, retrospective review from 15 centers of all patients who underwent placement of LAMSs for the management of PFCs. A nested case-control study was conducted in patients with (case) or without (control) AEs.

Results

Three hundred thirty-three procedures in 328 patients were performed (5 patients treated with 2 LAMSs). Technical success was achieved in 321 patients (97.9%). Three hundred four patients were finally included in the study (7 excluded for lost to follow-up information; 10 excluded for deaths unrelated to LAMSs). The rate of clinical success was 89.5%. Seventy-nine LAMS-related AEs occurred in 74 of 304 patients (24.3%), after a mean time of 25.3 days (median, 18 days; interquartile range, 6-30) classified as 20 (25.3%) mild, 54 (68.4%) moderate, or 5 (6.3%) severe. On multivariable analysis compared with control subjects, cases were more likely to have walled-off necrosis (WON) versus pancreatic pseudocysts (odds ratio, 2.18; 95% confidence interval, 1.09-4.46; P = .028), whereas cases were less likely to have undergone tract (balloon) dilation (yes vs no; odds ratio, .47; 95% confidence interval, .22-.93; P = .034).

Conclusions

Data from this large international retrospective study confirm that the use of LAMSs for management of PFCs has excellent technical and good clinical success rates. The rate of AEs, however, is not negligible and should be carefully considered before using these stents for drainage of PFCs and in particular for WON. Further prospective studies are needed to confirm these findings. (Clinical trial registration number: NCT 03544008.)

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Abbreviations : AE, ASGE, LAMS, PFC, MOF, OR, PP, SEMS, WON


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 DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: A. Sethi: Consultant for Boston Scientific, Olympus, and Fujifilm. A. J. Trindade: Consultant for Olympus America, Pentax America, C2 Therapeutics, and CSA Medical. M. A. Khashab: Consultant for Boston Scientific, Olympus, and Medtronic. F. P. Vleggaar, C. Fabbri, J. R. Aparicio, D. G. Adler: Consultant for Boston Scientific. R. P. Voermans: Consultant for and research grant recipient from Boston Scientific. G. Vanbiervliet: Consultant for Boston Scientific and Cook Medical. P. C. Benias: Consultant for Fujinon Medical, Apollo Endo Surgery, and Boston Scientific. A. Repici: Consultant for Boston Scientific and Fujifilm. A. Anderloni: Consultant for Boston Scientific and Olympus. All other authors disclosed no financial relationships.


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