Alessandro Fugazza1, Amrita Sethi2, Arvind J Trindade3, Edoardo Troncone4, John Devlin5, Mouen A Khashab6, Frank P Vleggaar7, Auke Bogte7, Ilaria Tarantino8, Pierre H Deprez9, Carlo Fabbri10, José Ramón Aparicio11, Paul Fockens12, Rogier P Voermans12, Will Uwe13, Geoffroy Vanbiervliet14, Antoine Charachon15, Christopher D Packey2, Petros C Benias3, Yasser El-Sherif5, Christopher Paiji6, Dario Ligresti8, Cecilia Binda10, Belén Martínez11, Loredana Correale16, Douglas G Adler17, Alessandro Repici18, Andrea Anderloni16. 1. Digestive Endoscopy Unit, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Italy. Electronic address: alessandro.fugazza@humanitas.it. 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. Digestive Endoscopy Unit, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Italy. 17. Division of Gastroenterology and Hepatology, University of Utah School of Medicine, Salt Lake City, Utah, USA. 18. Digestive Endoscopy Unit, Department of Gastroenterology, Humanitas Research Hospital, Rozzano, Italy; Humanitas University, Rozzano, 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: NCT03544008.).
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: NCT03544008.).
Authors: Mikhail Attaar; Bailey Su; Harry J Wong; Kristine Kuchta; Woody Denham; Stephen P Haggerty; John Linn; Michael B Ujiki Journal: Surg Endosc Date: 2020-08-11 Impact factor: 4.584
Authors: Ji Young Bang; C Mel Wilcox; Juan Pablo Arnoletti; Shajan Peter; John Christein; Udayakumar Navaneethan; Robert Hawes; Shyam Varadarajulu Journal: Dig Endosc Date: 2021-09-06 Impact factor: 6.337