International multicenter comprehensive analysis of adverse events associated with lumen-apposing metal stent placement for pancreatic fluid collection drainage - 29/02/20
, 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 1Abstract |
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.)
Le texte complet de cet article est disponible en PDF.Abbreviations : AE, ASGE, LAMS, PFC, MOF, OR, PP, SEMS, WON
Plan
| 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. |
Vol 91 - N° 3
P. 574-583 - mars 2020 Retour au numéro
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