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.)
Abbreviations:
AE (adverse event), ASGE (American Society for Gastrointestinal Endoscopy), LAMS (lumen-apposing metal stent), PFC (peripancreatic fluid collection), MOF (multiorgan failure), OR (odds ratio), PP (pancreatic pseudocyst), SEMS (self-expanding metallic stent), WON (walled-off necrosis)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: November 20, 2019
Accepted:
November 9,
2019
Received:
July 2,
2019
Footnotes
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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© 2020 by the American Society for Gastrointestinal Endoscopy
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Access this article on ScienceDirectLinked Article
- Adverse events of lumen-apposing stents for pancreatic fluid collections: opening Pandora’s boxGastrointestinal EndoscopyVol. 91Issue 5
- PreviewWe read with great interest the article by Fugazza et al,1 retrospectively evaluating the occurrence of adverse events (AEs) in 304 patients with pancreatic pseudocysts (PCs) (153) and walled-off necrosis (WON) (151) treated with lumen-apposing metal stents (LAMSs). Seventy-four (24.3%) patients experienced 79 AEs, of which bleeding (22), stent migration (20), stent occlusion (14), and infection (19) were the most frequently observed. At multivariate analysis, WON and lack of pneumatic tract dilation were the only statistically significant risk factors associated with AEs.
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