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

Published:November 20, 2019DOI:https://doi.org/10.1016/j.gie.2019.11.021

      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)
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      References

        • Banks P.A.
        • Bollen T.L.
        • Dervenis C.
        • et al.
        Classification of acute pancreatitis—2012: revision of the Atlanta classification and definitions by international consensus.
        Gut. 2013; 62: 102-111
        • Yeo C.J.
        • Bastidas J.A.
        • Lynch-Nyhan A.
        • et al.
        The natural history of pancreatic pseudocysts documented by computed tomography.
        Surg Gynecol Obstet. 1990; 170: 411-417
        • Cheruvu C.V.
        • Clarke M.G.
        • Prentice M.
        • et al.
        Conservative treatment as an option in the management of pancreatic pseudocyst.
        Ann R Coll Surg Engl. 2003; 85: 313-316
        • Alali A.
        • Mosko J.
        • May G.
        • et al.
        Endoscopic ultrasound-guided management of pancreatic fluid collections: update and review of the literature.
        Clin Endosc. 2017; 50: 117-125
        • Gomatos I.P.
        • Halloran C.M.
        • Ghaneh P.
        • et al.
        Outcomes from minimal access retroperitoneal and open pancreatic necrosectomy in 394 patients with necrotizing pancreatitis.
        Ann Surg. 2016; 263: 992-1001
        • Varadarajulu S.
        • Christein J.D.
        • Wilcox C.M.
        Frequency of complications during EUS-guided drainage of pancreatic fluid collections in 148 consecutive patients.
        J Gastroenterol Hepatol. 2011; 26: 1504-1508
        • Bakker O.J.
        • van Santvoort H.C.
        • van Brunschot S.
        • et al.
        Endoscopic transgastric vs surgical necrosectomy for infected necrotizing pancreatitis: a randomized trial.
        JAMA. 2012; 307: 1053-1061
        • McVay T.
        • Adler D.G.
        EUS-guided drainage of pancreatic fluid collections: double pigtails, metal biliary, or dedicated transluminal stents?.
        Endosc Ultrasound. 2015; 4: 1-3
        • Itoi T.
        • Binmoeller K.F.
        • Shah J.
        • et al.
        Clinical evaluation of a novel lumen-apposing metal stent for endosonography-guided pancreatic pseudocyst and gallbladder drainage (with videos).
        Gastrointest Endosc. 2012; 75: 870-876
        • Rinninella E.
        • Kunda R.
        • Dollhopf M.
        • et al.
        EUS-guided drainage of pancreatic fluid collections using a novel lumen-apposing metal stent on an electrocautery-enhanced delivery system: a large retrospective study (with video).
        Gastrointest Endosc. 2015; 82: 1039-1046
        • Gornals J.B.
        • De la Serna-Higuera C.
        • Sanchez-Yague A.
        • et al.
        Endosonography-guided drainage of pancreatic fluid collections with a novel lumen-apposing stent.
        Surg Endosc. 2013; 27: 1428-1434
        • Shah R.J.
        • Shah J.N.
        • Waxman I.
        • et al.
        Safety and efficacy of endoscopic ultrasound-guided drainage of pancreatic fluid collections with lumen-apposing covered self-expanding metal stents.
        Clin Gastroenterol Hepatol. 2015; 13: 747-752
        • Yang J.
        • Chen Y.I.
        • Friedland S.
        • et al.
        Lumen-apposing stents versus plastic stents in the management of pancreatic pseudocysts: a large, comparative, international, multicenter study.
        Endoscopy. 2019; 51: 1035-1043
        • Garcia-Alonso F.J.
        • Sanchez-Ocana R.
        • Penas-Herrero I.
        • et al.
        Cumulative risks of stent migration and gastrointestinal bleeding in patients with lumen-apposing metal stents.
        Endoscopy. 2018; 50: 386-395
        • Siddiqui A.A.
        • Kowalski T.E.
        • Loren D.E.
        • et al.
        Fully covered self-expanding metal stents versus lumen-apposing fully covered self-expanding metal stent versus plastic stents for endoscopic drainage of pancreatic walled-off necrosis: clinical outcomes and success.
        Gastrointest Endosc. 2017; 85: 758-765
        • Cotton P.B.
        • Eisen G.M.
        • Aabakken L.
        • et al.
        A lexicon for endoscopic adverse events: report of an ASGE workshop.
        Gastrointest Endosc. 2010; 71: 446-454
        • Anderloni A.
        • Attili F.
        • Carrara S.
        • et al.
        Intra-channel stent release technique for fluoroless endoscopic ultrasound-guided lumen-apposing metal stent placement: changing the paradigm.
        Endosc Int Open. 2017; 5: E25-E29
        • Breslow N.E.
        • Day N.E.
        Statistical methods in cancer research. Volume I—the analysis of case-control studies.
        IARC Sci Pub. 1980; 5: 338
        • Lakhtakia S.
        • Basha J.
        • Talukdar R.
        • et al.
        Endoscopic "step-up approach" using a dedicated biflanged metal stent reduces the need for direct necrosectomy in walled-off necrosis (with videos).
        Gastrointest Endosc. 2017; 85: 1243-1252
        • van Brunschot S.
        • van Grinsven J.
        • van Santvoort H.C.
        • et al.
        Endoscopic or surgical step-up approach for infected necrotising pancreatitis: a multicentre randomised trial.
        Lancet. 2018; 391: 51-58
        • Chandran S.
        • Efthymiou M.
        • Kaffes A.
        • et al.
        Management of pancreatic collections with a novel endoscopically placed fully covered self-expandable metal stent: a national experience (with videos).
        Gastrointest Endosc. 2015; 81: 127-135
        • Mukai S.
        • Itoi T.
        • Sofuni A.
        • et al.
        Clinical evaluation of endoscopic ultrasonography-guided drainage using a novel flared-type biflanged metal stent for pancreatic fluid collection.
        Endosc Ultrasound. 2015; 4: 120-125
        • Bang J.Y.
        • Navaneethan U.
        • Hasan M.K.
        • et al.
        Non-superiority of lumen-apposing metal stents over plastic stents for drainage of walled-off necrosis in a randomised trial.
        Gut. 2019; 68: 1200-1209
        • Varadarajulu S.
        • Bang J.Y.
        • Phadnis M.A.
        • et al.
        Endoscopic transmural drainage of peripancreatic fluid collections: outcomes and predictors of treatment success in 211 consecutive patients.
        J Gastrointest Surg. 2011; 15: 2080-2088
        • Yang D.
        • Perbtani Y.B.
        • Mramba L.K.
        • et al.
        Safety and rate of delayed adverse events with lumen-apposing metal stents (LAMS) for pancreatic fluid collections: a multicenter study.
        Endosc Int Open. 2018; 6: E1267-E1275
        • Bang J.Y.
        • Hasan M.
        • Navaneethan U.
        • et al.
        Lumen-apposing metal stents (LAMS) for pancreatic fluid collection (PFC) drainage: may not be business as usual.
        Gut. 2017; 66: 2054-2056
        • Dhir V.
        • Adler D.G.
        • Dalal A.
        • et al.
        Early removal of biflanged metal stents in the management of pancreatic walled-off necrosis: a prospective study.
        Endoscopy. 2018; 50: 597-605
        • van Santvoort H.C.
        • Bakker O.J.
        • Bollen T.L.
        • et al.
        A conservative and minimally invasive approach to necrotizing pancreatitis improves outcome.
        Gastroenterology. 2011; 141: 1254-1263
        • Bang J.Y.
        • Arnoletti J.P.
        • Holt B.A.
        • et al.
        An endoscopic transluminal approach, compared with minimally invasive surgery, reduces complications and costs for patients with necrotizing pancreatitis.
        Gastroenterology. 2019; 156: 1027-1040.e3
        • van Santvoort H.C.
        • Besselink M.G.
        • Bakker O.J.
        • et al.
        A step-up approach or open necrosectomy for necrotizing pancreatitis.
        N Engl J Med. 2010; 362: 1491-1502

      Linked Article

      • Adverse events of lumen-apposing stents for pancreatic fluid collections: opening Pandora’s box
        Gastrointestinal EndoscopyVol. 91Issue 5
        • Preview
          We 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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